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Application Docs

The document contains details of 62 supplemental application submissions to the FDA, including application number, submission type, submission number, document title, URL, and date. Each entry provides information about a specific supplemental submission made to the FDA regarding an application.

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RohitKumar

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0% found this document useful (0 votes)

60 views3,809 pages

Application Docs

Uploaded by

RohitKumar

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as TXT, PDF, TXT or read online on Scribd

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ApplicationDocsID ApplicationDocsTypeID ApplNo SubmissionType SubmissionNo

ApplicationDocsTitle ApplicationDocsURL ApplicationDocsDate

1 1 004782 SUPPL 125 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr125ltr.pdf
2003-07-28 00:00:00
2 1 004782 SUPPL 128 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/04782slr128ltr.pdf
2002-11-27 00:00:00
3 1 004782 SUPPL 130 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-
115,slr130ltr.pdf 2003-05-16 00:00:00
4 1 004782 SUPPL 138 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf
2005-04-12 00:00:00
5 1 004782 SUPPL 141 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s141ltr.pdf
2005-08-04 00:00:00
6 1 004782 SUPPL 142 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s142ltr.pdf
2005-11-03 00:00:00
7 1 004782 SUPPL 147 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/04782s147_ltr.pdf
2006-09-18 00:00:00
8 1 004782 SUPPL 164 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167l
tr.pdf 2011-10-31 00:00:00
9 1 004782 SUPPL 167 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167l
tr.pdf 2011-10-31 00:00:00
10 1 004782 SUPPL 171 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/004782Orig1s171ltr.pdf
2014-12-04 00:00:00
11 1 005010 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr047ltr.pdf
2003-03-10 00:00:00
12 1 005010 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005010s049ltr.pdf
2009-03-10 00:00:00
13 1 005010 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s050ltr.pdf
2011-04-13 00:00:00
14 1 005213 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005213s037ltr.pdf
2009-01-30 00:00:00
15 1 005378 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s027ltr.pdf
2013-08-27 00:00:00
16 1 005619 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619s16ltr.pdf
2004-05-27 00:00:00
17 1 005856 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005856s020ltr.pdf
2009-04-29 00:00:00
18 1 005929 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and2014
8slr007,008ltr.pdf 2003-07-31 00:00:00
19 1 005939 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/05939s007Ltr.pdf
2007-04-25 00:00:00
20 1 006002 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06002slr039ltr.pdf
2003-06-22 00:00:00
21 1 006002 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/006002s042ltr.pdf
2009-06-17 00:00:00
22 1 006035 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06035slr072ltr.pdf
2004-03-02 00:00:00
23 1 006035 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06035slr073ltr.pdf
2003-10-09 00:00:00
24 1 006134 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/06134s028ltr.pdf
2006-12-04 00:00:00
25 1 006134 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006134Orig1s032ltr.pdf
2013-04-16 00:00:00
26 1 006134 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s035ltr.pdf
2014-04-17 00:00:00
27 1 006134 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s036ltr.pdf
2014-08-20 00:00:00
28 1 006134 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s039ltr.pdf
2016-04-22 00:00:00
29 1 006188 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf
2011-07-29 00:00:00
30 1 006695 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06695slr030ltr.pdf
2003-03-26 00:00:00
31 1 006773 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06773slr036ltr.pdf
2003-07-06 00:00:00
32 1 006882 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06882slr033ltr.pdf
2003-06-08 00:00:00
33 1 006927 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr02
1ltr.pdf 2004-06-03 00:00:00
34 1 007073 SUPPL 126 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007073Orig1s126ltr.pdf
2013-07-22 00:00:00
35 1 007337 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/07337slr029ltr.pdf
2004-06-15 00:00:00
36 1 007337 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/07337s043LTR.pdf
2006-08-21 00:00:00
37 1 007337 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/007337s046ltr.pdf
2010-07-30 00:00:00
38 1 007409 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370
Orig1s033ltr.pdf 2013-01-15 00:00:00
39 1 007638 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/007638s032ltr.pdf
2006-01-30 00:00:00
40 1 007638 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/007638s033ltr.pdf
2008-02-07 00:00:00
41 1 007935 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr
.pdf 2002-12-26 00:00:00
42 1 007935 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr
.pdf 2002-12-26 00:00:00
43 1 007935 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/07935s030ltr.pdf
2004-11-15 00:00:00
44 1 007961 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,
008370s032ltr.pdf 2011-08-02 00:00:00
45 1 000793 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/000793s025ltr.pdf
2007-10-04 00:00:00
46 1 001546 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/1546s011.pdf
2002-04-24 00:00:00
47 1 003444 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/03444slr020ltr.pdf
2003-11-25 00:00:00
48 1 004782 SUPPL 93 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093_premarin_appltrs.pdf
1998-09-08 00:00:00
49 1 004782 SUPPL 115 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-
115,slr130ltr.pdf 2003-05-16 00:00:00
50 1 004782 SUPPL 129 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr129ltr.pdf
2003-01-07 00:00:00
51 1 004782 SUPPL 133 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf
2004-04-29 00:00:00
52 1 004782 SUPPL 136 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf
2004-04-29 00:00:00
53 1 004782 SUPPL 137 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782s137ltr.pdf
2004-08-31 00:00:00
54 1 004782 SUPPL 139 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf
2005-04-12 00:00:00
55 1 004782 SUPPL 146 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/004782s146LTR.pdf
2006-04-25 00:00:00
56 1 004782 SUPPL 155 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/004782s155ltr.pdf
2008-03-05 00:00:00
57 1 004782 SUPPL 162 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167l
tr.pdf 2011-10-31 00:00:00
58 1 005010 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr048ltr.pdf
2003-06-08 00:00:00
59 1 005010 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s051ltr.pdf
2011-11-02 00:00:00
60 1 005378 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05378s024ltr.pdf
2006-04-13 00:00:00
61 1 005378 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/005378s026ltr.pdf
2007-05-16 00:00:00
62 1 005378 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s028ltr.pdf
2013-12-09 00:00:00
63 1 005378 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/005378Orig1s030ltr.pdf
2015-04-21 00:00:00
64 1 005619 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619slr018ltr.pdf
2004-05-28 00:00:00
65 1 005619 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/005619s020ltr.pdf
2005-06-07 00:00:00
66 1 005619 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005619s021ltr.pdf
2011-03-23 00:00:00
67 1 005856 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/005856s021ltr.pdf
2012-06-08 00:00:00
68 1 005929 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and2014
8slr007,008ltr.pdf 2003-07-31 00:00:00
69 1 006002 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006002Orig1s043ltr.pdf
2013-11-08 00:00:00
70 1 006035 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/006035s07LTRd.pdf
2007-05-01 00:00:00
71 1 006035 SUPPL 78 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006035s078ltr.pdf
2012-06-27 00:00:00
72 1 006134 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s030ltr.pdf
2012-07-11 00:00:00
73 1 006134 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s031ltr.pdf
2012-07-11 00:00:00
74 1 006134 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s037ltr.pdf
2015-06-29 00:00:00
75 1 006134 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s038ltr.pdf
2015-04-03 00:00:00
76 1 006188 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006188s020ltr.pdf
2010-04-05 00:00:00
77 1 006188 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf
2011-07-29 00:00:00
78 1 006188 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006188Orig1s024ltr.pdf
2015-02-12 00:00:00
79 1 006188 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006188Orig1s025ltr.pdf
2016-01-20 00:00:00
80 1 006488 SUPPL 74 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006488s074ltr.pdf
2010-03-18 00:00:00
81 1 006695 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06695slr031ltr.pdf
2004-03-02 00:00:00
82 1 006927 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr02
1ltr.pdf 2003-07-06 00:00:00
83 1 007073 SUPPL 115 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/07073s115ltr.pdf
2004-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7073slr120ltr.pdf
2004-05-27 00:00:00
85 1 007073 SUPPL 125 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/007073Orig1s125ltr.pdf
2012-12-18 00:00:00
86 1 007073 SUPPL 128 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/007073Orig1s128ltr.pdf
2014-03-06 00:00:00
87 1 007337 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/007337s045ltr.pdf
2010-03-18 00:00:00
88 1 007409 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf
2002-02-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008306s030ltr.pdf
2008-11-28 00:00:00
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2003-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008316s017ltr.pdf
2008-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008316Orig1s021ltr.pdf
2015-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008316Orig1s022ltr.pdf
2016-07-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08-
370slr030ltr.pdf 2002-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008372s045ltr.pdf
2012-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf
2003-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008381s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063l
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r.pdf 2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16084slr041ltr.pdf
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.pdf 2005-02-11 00:00:00
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2001-06-29 00:00:00
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6ltr.pdf 2003-06-22 00:00:00
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2001-04-09 00:00:00
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2002-02-14 00:00:00
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2007-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016267s045ltr.pdf
2009-01-30 00:00:00
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2006-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016273s066ltr.pdf
2012-03-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16295S34ltr.pdf
2001-04-04 00:00:00
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036ltr.pdf 2003-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16295slr037ltr.pdf
2004-03-02 00:00:00
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016295s036ltr.pdf 2006-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf
2012-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf
2012-01-30 00:00:00
435 1 016295 SUPPL 45 0

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2015-07-20 00:00:00
436 1 016295 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s046ltr.pdf
2015-07-20 00:00:00
437 1 016295 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016295Orig1s047,s048lt
r.pdf 2016-03-25 00:00:00
438 1 016320 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf
2003-02-06 00:00:00
439 1 016320 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016320s063ltr.pdf
2008-11-03 00:00:00
440 1 016324 SUPPL 26 0

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1ltr.pdf 2004-06-07 00:00:00
441 1 016324 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391
s015ltr.pdf 2011-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016367s178ltr.pdf
2005-09-07 00:00:00
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2004-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016418s076ltr.pdf
2007-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016419s026LTR.pdf
2006-07-27 00:00:00
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2006-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf
2009-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016466Orig1s046ltr.pdf
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018927s035,020234s025ltr.pdf 2007-08-17 00:00:00
459 1 016608 SUPPL 99 0

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Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf 2014-09-17 00:00:00
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s049,s050,018927s041,s042,020234s031,s033ltr.pdf 2011-03-07 00:00:00
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tr.pdf 2009-05-01 00:00:00
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s049,s050,018927s041,s042,020234s031,s033ltr.pdf 2011-03-07 00:00:00
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et al_ltr.pdf 2005-09-07 00:00:00
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016693s096ltr.pdf 2013-09-13 00:00:00
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Orig1s062,019022Orig1s026ltr.pdf 2014-12-30 00:00:00
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016692s095,019367s026ltr.pdf 2011-10-24 00:00:00
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r043,%2016862slr033ltr.pdf 2002-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,
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2002-04-03 00:00:00
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Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf
2013-09-12 00:00:00
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016758s019, 016904s033ltr.pdf 2008-04-17 00:00:00
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16s2320990s252719839s596364ltr.pdf 2007-08-07 00:00:00
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2003-07-31 00:00:00
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2013-02-13 00:00:00
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2ltr.pdf 2002-05-08 00:00:00
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2ltr.pdf 2002-05-08 00:00:00
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2ltr.pdf 2002-05-08 00:00:00
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9,18152slr017ltr.pdf 2004-06-03 00:00:00
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0ltr.pdf 2004-03-16 00:00:00
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r043,%2016862slr033ltr.pdf 2004-06-02 00:00:00
512 1 016862 SUPPL 41 0

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041,042,017122s061,062ltr.pdf 2009-11-13 00:00:00
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016758s019, 016904s033ltr.pdf 2008-04-17 00:00:00
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017373s038,018849s018ltr.pdf 2006-01-19 00:00:00
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518 1 016964 SUPPL 69 0

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022046s004ltr.pdf 2012-02-01 00:00:00
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2002-08-27 00:00:00
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Orig1s035ltr.pdf 2015-07-10 00:00:00
524 1 017001 SUPPL 19 0

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f 2003-05-29 00:00:00
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2009-05-07 00:00:00
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2020-03-23 00:00:00
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Orig1s062,020067Orig1s019ltr.pdf 2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17588slr031ltr.pdf
2002-12-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17588slr033ltr.pdf
2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017588s034ltr.pdf
2009-05-06 00:00:00
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2012-11-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017588s037ltr.pdf
2011-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017588Orig1s040ltr.pdf
2014-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s042ltr.pdf
2016-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17601slr020LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017604s041ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017604s043ltr.pdf
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2008-01-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017634s064ltr.pdf
2005-05-25 00:00:00
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et al_ltr.pdf 2005-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018449s039,017643s072l
tr.pdf 2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017648s064ltr.pdf
2005-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,
et al_ltr.pdf 2005-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017651s046ltr.pdf
2009-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052l
tr.pdf 2011-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055l
tr.pdf 2011-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651
Orig1s059.pdf 2014-04-07 00:00:00
678 1 017670 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17670slr043ltr.pdf
2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673slr065,17789slr05
1ltr.pdf 2003-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673scs067ltr.pdf
2003-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17681slr013ltr.pdf
2004-06-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17681s014ltr.pdf
2005-11-30 00:00:00
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017683s008ltr.pdf 2011-04-01 00:00:00
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2001-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17691s19ltr.pdf
2001-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017692s018ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017692s021ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017693Orig1s029ltr.pdf
2015-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp
014,scs015ltr.pdf 2004-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp
014,scs015ltr.pdf 2004-06-07 00:00:00
691 1 017697 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp
014,scs015ltr.pdf 2004-06-07 00:00:00
692 1 017703 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16832slr022,17703slr01
8ltr.pdf 2003-11-25 00:00:00
693 1 017735 SUPPL 107 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,0
18985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 2012-06-20 00:00:00
694 1 017735 SUPPL 110 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919
Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf
2013-10-04 00:00:00
695 1 017741 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17741slr022ltr.pdf
2003-12-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17760s9ltr.pdf
2001-07-13 00:00:00
697 1 017760 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017760s015ltr.pdf
2007-09-25 00:00:00
698 1 017768 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017768Orig1s041ltr.pdf
2014-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17781s15ltr.pdf
2001-10-03 00:00:00
700 1 017783 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017783s020ltr.pdf
2009-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017783s021ltr.pdf
2011-02-09 00:00:00
702 1 017783 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017783Orig1s025ltr.pdf
2013-10-16 00:00:00
703 1 017789 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673slr065,17789slr05
1ltr.pdf 2003-06-22 00:00:00
704 1 017789 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm05
2,etc,ltr.pdf 2004-05-27 00:00:00
705 1 017794 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017794s035_LTR.pdf
2007-04-25 00:00:00
706 1 017808 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17808slr024ltr.pdf
2003-06-08 00:00:00
707 1 017808 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017808Orig1s035ltr.pdf
2014-03-13 00:00:00
708 1 017808 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017808Orig1s036ltr.pdf
2015-02-03 00:00:00
709 1 017812 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
2001-11-26 00:00:00
710 1 017812 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17812s21ltr.pdf
2001-06-14 00:00:00
711 1 017812 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr02
1ltr.pdf 2003-01-31 00:00:00
712 1 017814 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18
332s028ltr.pdf 2005-03-29 00:00:00
713 1 017814 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042lt
r.pdf 2016-05-11 00:00:00
714 1 017820 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17820slr037ltr.pdf
2002-07-23 00:00:00
715 1 017824 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17824s024ltr.pdf
2004-10-04 00:00:00
716 1 017830 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,01
7,018,019,030ltr.pdf 2014-02-25 00:00:00
717 1 017830 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,01
7,018,019,030ltr.pdf 2014-02-25 00:00:00
718 1 017830 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,01
7,018,019,030ltr.pdf 2014-02-25 00:00:00
719 1 017831 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17831slr053ltr.pdf
2004-02-27 00:00:00
720 1 017831 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s057ltr.pdf
2015-03-19 00:00:00
721 14 017836 SUPPL 8 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
722 1 017854 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004l
tr.pdf 2009-07-06 00:00:00
723 1 017854 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005l
tr.pdf 2009-10-26 00:00:00
724 1 017858 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17858slr024ltr.pdf
2002-09-13 00:00:00
725 1 017858 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017858Orig1s035ltr.pdf
2012-08-16 00:00:00
726 1 017862 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf
2004-04-29 00:00:00
727 1 017862 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017862s061ltr.pdf
2009-07-06 00:00:00
728 1 017865 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr038ltr.pdf
2002-07-17 00:00:00
729 1 017865 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr040ltr.pdf
2002-09-03 00:00:00
730 1 017865 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr041ltr.pdf
2002-09-03 00:00:00
731 1 017865 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017865s045ltr.pdf
2006-03-01 00:00:00
732 1 017874 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17874s18s27ltr.pdf
2001-07-26 00:00:00
733 1 017874 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017874s035_ltr.pdf
2007-01-16 00:00:00
734 1 017875 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr04
6,17875slr032,17876slr031ltr.pdf 2003-05-30 00:00:00
735 1 017876 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr04
6,17875slr032,17876slr031ltr.pdf 2003-05-30 00:00:00
736 14 017881 SUPPL 4 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
737 14 017881 SUPPL 10 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
738 14 017881 SUPPL 16 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
739 14 017881 SUPPL 25 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
740 1 017892 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017892s038ltr.pdf
2008-02-14 00:00:00
741 1 017911 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s065ltr.pdf
2006-10-13 00:00:00
742 1 017911 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s068ltr.pdf
2006-01-30 00:00:00
743 1 017911 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017911s070ltr.pdf
2007-08-27 00:00:00
744 1 017911 SUPPL 74 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s074ltr.pdf
2010-12-28 00:00:00
745 1 017919 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919
Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf
2013-10-04 00:00:00
746 1 017919 SUPPL 99 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919
Orig1s099,018985Orig1s063ltr.pdf 2015-11-04 00:00:00
747 1 017920 SUPPL 95 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017920s095_ltr.pdf
2006-07-21 00:00:00
748 1 017922 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr01
9,19955slr005ltr.pdf 2003-11-25 00:00:00
749 1 017922 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938
Orig1s029ltr.pdf 2015-11-09 00:00:00
750 1 017923 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF
2001-03-15 00:00:00
752 1 017938 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf
2001-05-22 00:00:00
753 1 017943 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17943slr016ltr.pdf
2002-08-26 00:00:00
754 1 017943 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017943s017ltr.pdf
2006-01-20 00:00:00
755 1 017955 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
2002-06-10 00:00:00
756 1 017957 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17957slr032ltr.pdf
2003-05-29 00:00:00
757 1 017957 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17957s039ltr.pdf
2005-01-13 00:00:00
758 1 017963 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018704s018,
017963s059_ltr.pdf 2006-09-18 00:00:00
759 1 017963 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s062,018704s021l
tr.pdf 2008-07-30 00:00:00
760 1 017963 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023l
tr.pdf 2010-01-06 00:00:00
761 1 017963 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017963Orig1s067ltr.pdf
2012-12-26 00:00:00
762 1 017970 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s40.pdf
1998-10-29 00:00:00
763 1 017970 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf
2002-05-16 00:00:00
764 1 017970 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17970slr048ltr.pdf
2003-06-22 00:00:00
765 1 017970 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf
2002-05-16 00:00:00
766 1 017970 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17970s052ltr.pdf
2004-12-30 00:00:00
767 1 017970 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17970s053ltr.pdf
2005-03-23 00:00:00
768 1 017970 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017970s054ltr.pdf
2006-03-23 00:00:00
769 1 017989 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017989Orig1s019ltr.pdf
2013-12-13 00:00:00
770 1 017994 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17994slr022ltr.pdf
2003-06-08 00:00:00
771 1 018008 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr06
3,19308slr020ltr.pdf 2004-06-07 00:00:00
772 1 018008 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066,
018037s066, 019308s023ltr.pdf 2007-05-01 00:00:00
773 1 018008 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037
Orig1s070,019308Orig1s027ltr.pdf 2013-09-12 00:00:00
774 1 018012 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr
.pdf 2005-01-13 00:00:00
775 1 018012 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,180
13s58,19906s34ltr.pdf 2007-07-24 00:00:00
776 1 018012 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012
Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf 2012-10-29 00:00:00
777 1 018012 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013
Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf 2014-07-11 00:00:00
778 1 018013 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,180
13s58,19906s34ltr.pdf 2007-07-24 00:00:00
779 1 018013 SUPPL 63 0

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Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf 2014-07-29 00:00:00
780 1 018016 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf
2002-04-03 00:00:00
781 1 018016 SUPPL 53 0

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18723s024,19680s015,20593s009,2116 2004-06-02 00:00:00
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052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s
031,020593s016,s020,s023ltr.pdf 2011-10-13 00:00:00
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2004-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018716s026ltr.pdf
2010-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18726slr012,009ltr.pdf
2002-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18726slr012,009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18731s46ltr.pdf
2002-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018731s051ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18733slr012ltr.pdf
2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18737slr003ltr.pdf
2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018738s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s028LTR.pdf
2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018760s027ltr.pdf
2008-10-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018760Orig1s029ltr.pdf
2012-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18763slr003ltr.pdf
2004-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018766s013ltr.pdf
2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018766Orig1s020ltr.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18771s12ltr.pdf
2002-03-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18776slr027ltr.pdf
2003-06-08 00:00:00
1069 14 018780 SUPPL 66 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1070 14 018780 SUPPL 80 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1071 14 018780 SUPPL 86 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1072 14 018780 SUPPL 94 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1073 14 018780 SUPPL 95 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1074 14 018780 SUPPL 120 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1075 14 018780 SUPPL 124 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1076 14 018780 SUPPL 133 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1077 14 018780 SUPPL 135 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1078 14 018780 SUPPL 153 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1079 14 018781 SUPPL 54 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1080 14 018781 SUPPL 57 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1081 14 018781 SUPPL 60 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1082 14 018781 SUPPL 74 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1083 14 018781 SUPPL 76 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1084 14 018781 SUPPL 79 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1085 14 018781 SUPPL 80 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1086 14 018781 SUPPL 85 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1087 14 018781 SUPPL 114 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1088 14 018781 SUPPL 121 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1089 14 018781 SUPPL 122 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1090 14 018781 SUPPL 154 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018782Orig1s036ltr.pdf
2013-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018796s014ltr.pdf
2008-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018817s022ltr.pdf
2010-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s024ltr.pdf
2011-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s027ltr.pdf
2011-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf
2002-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018132Orig1s067,018826
Orig1s045ltr.pdf 2014-05-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18827slr025ltr.pdf
2003-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018827s038ltr.pdf
2008-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018827s042ltr.pdf
2009-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018827Orig1s046ltr.pdf
2014-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020,
019909s022, 018828s031ltr.pdf 2008-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,
et al_ltr.pdf 2005-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf
2002-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018841s022ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018851Orig1s025ltr.pdf
2016-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18869S10LTR.PDF
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18873slr018ltr.pdf
2004-06-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18874s16ltr.pdf
2003-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018874s022ltr.pdf
2012-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf
2003-05-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018878s024ltr.pdf
2007-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018883s033,020171s015l
tr.pdf 2009-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018883Orig1s051,20171O
rig1s033ltr.pdf 2014-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018883Orig1s057,020171
Orig1s039ltr.pdf 2015-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18887slr020ltr.pdf
2004-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18891s022ltr.pdf
2004-08-25 00:00:00
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2010-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18892s21ltr.pdf
2002-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18893scs017ltr.pdf
2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18896scs012ltr.pdf
2002-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018900Orig1s031ltr.pdf
2015-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018900Orig1s032ltr.pdf
2015-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018916Orig1s060ltr.pdf
2013-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18920slr024ltr.pdf
2002-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018925s008ltr.pdf
2011-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016608s101,018927s043l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018932Orig1s017ltr.pdf
2013-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18936S58LTR.PDF
2000-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18936s070ltr.pdf
2004-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf
2009-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18956slr039ltr.pdf
2002-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18956slr058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s041ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s050ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s058ltr.pdf
2011-09-13 00:00:00
1304 1 019384 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s062ltr.pdf
2012-02-13 00:00:00
1305 1 019384 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s065ltr.pdf
2013-03-29 00:00:00
1306 1 019384 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s066ltr.pdf
2013-08-16 00:00:00
1307 1 019384 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019384Orig1s067ltr.pdf
2016-07-26 00:00:00
1308 1 019385 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19385slr028ltr.pdf
2002-08-29 00:00:00
1309 1 019385 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr
.pdf 2003-10-09 00:00:00
1310 1 019386 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf
2003-01-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf021ltr.pdf
2003-03-10 00:00:00
1312 1 019386 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf024ltr.pdf
2003-08-26 00:00:00
1313 1 019389 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019389s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19404scp020ltr.pdf
2004-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019404Orig1s026ltr.pdf
2012-07-30 00:00:00
1316 1 019414 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19414S6ltr.pdf
2001-04-11 00:00:00
1317 1 019414 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019414s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019414s014ltr.pdf
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1319 1 019422 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019422s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s036ltr.pdf
2009-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s037ltr.pdf
2009-02-27 00:00:00
1322 1 019422 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019422Orig1s043ltr.pdf
2012-12-18 00:00:00
1323 1 019430 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430orig1s058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019439s022ltr.pdf
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1325 1 019445 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19445s4ltr.pdf
1998-11-23 00:00:00
1326 1 019452 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19452s15ltr.pdf
1999-08-18 00:00:00
1327 1 019452 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.
pdf 2005-11-18 00:00:00
1328 1 019452 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19452s17ltr.pdf
2001-10-10 00:00:00
1329 1 019452 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19452scp018ltr.pdf
2003-05-29 00:00:00
1330 1 019452 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.
pdf 2005-11-18 00:00:00
1331 1 019462 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20752s6ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019462s035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19463slr026ltr.pdf
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Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf 2016-06-14
00:00:00
1337 1 019479 SUPPL 49 0

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Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf 2016-06-14
00:00:00
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Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf 2016-06-14
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487scf022ltr.pdf
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1340 1 019487 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019487s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm05
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019501Orig1s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019507s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019508s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272
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1358 1 019516 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s044ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s047ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19525S010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019527s028ltr.pdf
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lr016,018,19964slr011,014ltr.pdf 2003-03-25 00:00:00
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4Orig1s030ltr.pdf 2013-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019583s023ltr.pdf
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1399 1 019583 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019583s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr022ltr.pdf
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tr.pdf 2008-09-26 00:00:00
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021037s018ltr.pdf 2007-09-06 00:00:00
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tr.pdf 2010-12-22 00:00:00
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tr.pdf 2012-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019596Orig1s056,021037
Orig1s029ltr.pdf 2013-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19600slr006,009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019614Orig1s050ltr.pdf
2014-10-10 00:00:00
1418 1 019615 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019615s021ltr.pdf
2012-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr
.pdf 2002-08-21 00:00:00
1420 1 019617 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019617s010ltr.pdf
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1421 1 019618 SUPPL 16 0
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013ltr.pdf 2002-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19625slr012,se5-
013ltr.pdf 2002-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019625Orig1s024ltr.pdf
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1425 1 019627 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19627S35LTR.pdf
2001-02-23 00:00:00
1426 1 019630 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19630s023ltr.pdf
2004-09-29 00:00:00
1427 1 019634 SUPPL 33 0

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2013-02-15 00:00:00
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1431 14 019640 SUPPL 45 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1432 14 019640 SUPPL 47 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1433 14 019640 SUPPL 52 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1434 14 019640 SUPPL 58 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1435 14 019640 SUPPL 68 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1436 14 019640 SUPPL 70 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1437 14 019640 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1438 14 019640 SUPPL 86 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1439 14 019640 SUPPL 92 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1440 1 019641 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr02
2,19964slr021ltr.pdf 2004-06-30 00:00:00
1441 1 019641 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019579Orig1s035,019641
s028,019964Orig1s030ltr.pdf 2013-10-01 00:00:00
1442 1 019641 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641
Orig1s030,019964Orig1s032ltr.pdf 2014-07-25 00:00:00
1443 1 019643 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s061_LTR.pdf
2007-04-25 00:00:00
1444 1 019643 SUPPL 71 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643slr071ltr.pdf
2002-09-20 00:00:00
1445 1 019643 SUPPL 76 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s076ltr.pdf
2005-11-18 00:00:00
1446 1 019643 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s079ltr.pdf
2008-01-09 00:00:00
1447 1 019643 SUPPL 81 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019643s081ltr.pdf
2010-07-02 00:00:00
1448 1 019643 SUPPL 84 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019643s084ltr.pdf
2011-02-07 00:00:00
1449 1 019643 SUPPL 87 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087lt
r.pdf 2012-11-05 00:00:00
1450 1 019643 SUPPL 88 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019643Orig1s088ltr.pdf
2014-02-28 00:00:00
1451 1 019645 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s017ltr.pdf
2007-11-19 00:00:00
1452 1 019645 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019645s018ltr.pdf
2008-12-19 00:00:00
1453 1 019645 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019645Orig1s019ltr.pdf
2013-03-28 00:00:00
1454 1 019649 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf
2001-04-11 00:00:00
1455 1 019649 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s014ltr.pdf
2008-11-25 00:00:00
1456 1 019650 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf
2001-04-11 00:00:00
1457 1 019650 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019649s010;019650s007l
tr.pdf 2007-03-23 00:00:00
1458 1 019651 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019651s016LTR.pdf
2007-04-20 00:00:00
1459 1 019651 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019651s023ltr.pdf
2010-05-28 00:00:00
1460 1 019651 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019651Orig1s024ltr.pdf
2013-10-21 00:00:00
1461 1 019653 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,0
18985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 2012-06-20 00:00:00
1462 1 019653 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919
Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf
2013-10-04 00:00:00
1463 1 019653 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697
Orig1s052,021690Orig1s001ltr.pdf 2015-05-04 00:00:00
1466 1 019655 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF
2001-03-30 00:00:00
1467 1 019655 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf
2002-02-21 00:00:00
1468 1 019655 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,
020518s019ltr.pdf 2010-05-21 00:00:00
1469 1 019655 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,
020518s022ltr.pdf 2011-12-01 00:00:00
1470 1 019658 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-
020,20704se6-009,20641se6-011ltr.pdf 2003-11-25 00:00:00
1471 1 019658 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658slr021ltr.pdf
2003-07-06 00:00:00
1472 1 019658 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019658Orig1s044ltr.pdf
2015-12-22 00:00:00
1473 1 019660 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19660slr017ltr.pdf
2004-03-02 00:00:00
1474 1 019667 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf
2002-07-24 00:00:00
1475 1 019667 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm044ltr.pdf
2003-01-17 00:00:00
1476 1 019667 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019667s050ltr.pdf
2005-09-08 00:00:00
1477 1 019667 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653Orig1s058,19697O
rig1s054ltr.pdf 2008-08-28 00:00:00
1478 1 019667 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023l
tr.pdf 2010-02-05 00:00:00
1479 1 019667 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019667Orig1s059ltr.pdf
2014-02-11 00:00:00
1480 1 019668 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19668s15ltr.pdf
2002-01-23 00:00:00
1481 1 019668 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019668s017ltr.pdf
2006-03-03 00:00:00
1482 1 019668 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019668Orig1s028ltr.pdf
2016-06-10 00:00:00
1483 1 019670 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019670s020ltr.pdf
2009-04-27 00:00:00
1484 1 019670 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034lt
r.pdf 2010-02-17 00:00:00
1485 1 019670 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470
Orig1s044ltr.pdf 2015-11-27 00:00:00
1486 1 019675 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19675S20_zantacsyrup_approv.pd
f 2003-04-30 00:00:00
1487 1 019675 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,
020251s016ltr.pdf 2005-05-02 00:00:00
1488 1 019675 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,
020251s018ltr.pdf 2009-02-19 00:00:00
1489 14 019676 SUPPL 16 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1490 14 019676 SUPPL 21 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1491 14 019676 SUPPL 26 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1492 1 019677 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019677s005,019678s005l
tr.pdf 2005-12-15 00:00:00
1493 1 019680 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,
18723s024,19680s015,20593s009,2116 2004-06-02 00:00:00
1494 1 019680 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019680s019ltr.pdf
2006-01-20 00:00:00
1495 1 019680 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019680s021ltr.pdf
2006-12-28 00:00:00
1496 1 019680 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s
15,18723s33,19680s22,21168s14.pdf 2006-10-23 00:00:00
1497 1 019680 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019680s026ltr.pdf
2009-05-01 00:00:00
1498 1 019680 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19681scs020ltr.pdf
2004-05-27 00:00:00
1505 1 019682 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19682slr015,018ltr.pdf
2004-05-27 00:00:00
1506 1 019682 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19682slr015,018ltr.pdf
2004-05-27 00:00:00
1507 1 019682 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19682scs020ltr.pdf
2004-05-27 00:00:00
1508 1 019683 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19683scs021ltr.pdf
2004-05-27 00:00:00
1509 1 019683 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019683s027ltr.pdf
2005-10-11 00:00:00
1510 1 019684 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019684s023ltr.pdf
2010-10-07 00:00:00
1511 1 019684 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019684Orig1s026ltr.pdf
2013-07-29 00:00:00
1512 1 019697 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019653s037,019697s034l
tr.pdf 2007-05-09 00:00:00
1513 1 019697 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,0
18985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 2012-06-20 00:00:00
1514 1 019697 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19700S023,024ltr.pdf
2005-03-11 00:00:00
1517 1 019700 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019700s028ltr.pdf
2012-06-18 00:00:00
1518 1 019710 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s034ltr.pdf
2008-04-30 00:00:00
1519 1 019710 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923
Orig1s018ltr.pdf 2015-07-10 00:00:00
1520 1 019715 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715s18ltr.pdf
2002-01-18 00:00:00
1521 1 019715 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715scs021ltr.pdf
2002-08-09 00:00:00
1522 1 019715 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019715s025ltr.pdf
2007-07-16 00:00:00
1523 1 019715 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019715s027ltr.pdf
2009-11-12 00:00:00
1524 1 019716 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019716s006ltr.pdf
2005-10-14 00:00:00
1525 1 019716 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s021LTR.pdf
2006-04-25 00:00:00
1526 14 019717 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1527 14 019717 SUPPL 41 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1528 14 019717 SUPPL 50 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1529 14 019717 SUPPL 54 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1530 14 019717 SUPPL 60 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1531 14 019717 SUPPL 68 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1532 14 019717 SUPPL 69 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1533 14 019717 SUPPL 87 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1534 14 019717 SUPPL 94 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1535 14 019717 SUPPL 98 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1536 14 019717 SUPPL 99 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1537 14 019717 SUPPL 101 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1538 14 019717 SUPPL 124 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1539 14 019717 SUPPL 133 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1540 1 019722 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19722s004ltr.pdf
2002-06-14 00:00:00
1541 1 019722 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19722slr006ltr.pdf
2004-06-09 00:00:00
1542 1 019726 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046l
tr.pdf 2005-10-25 00:00:00
1543 1 019726 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052lt
r.pdf 2010-01-07 00:00:00
1544 1 019726 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052lt
r.pdf 2010-01-07 00:00:00
1545 1 019726 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032l
tr.pdf 2011-01-20 00:00:00
1546 1 019726 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,0
20578Orig1s034,s035ltr.pdf 2013-06-20 00:00:00
1547 1 019726 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019726Orig1s058,020578
Orig1s036ltr.pdf 2014-10-09 00:00:00
1548 1 019726 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578
Orig1s037ltr.pdf 2015-02-17 00:00:00
1549 1 019732 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON
%20DEPOT_APPROV.PDF 2003-05-30 00:00:00
1550 1 019732 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
222420517181920708202120011tr.pdf 2005-10-20 00:00:00
1551 1 019732 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,
s035,s036,020517s024,s028,s029ltr.pdf 2010-05-04 00:00:00
1552 1 019732 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,
020517Orig1s031ltr_C.pdf 2011-01-20 00:00:00
1553 1 019732 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517
Orig1s035,019732Orig1s000ltr.pdf 2013-07-12 00:00:00
1554 1 019732 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517
Orig1s036ltr.pdf 2014-07-01 00:00:00
1555 1 019732 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517
Orig1s038ltr.pdf 2016-06-08 00:00:00
1556 1 019734 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s013ltr.pdf
2008-08-05 00:00:00
1557 1 019734 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s014ltr.pdf
2008-11-13 00:00:00
1558 1 019734 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019734s017ltr.pdf
2011-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019734Orig1s023ltr.pdf
2014-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s055LTR.pdf
2006-06-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s056ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s058ltr..pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019735s059ltr.pdf
2008-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019735s060ltr.pdf
2009-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019735s061ltr.pdf
2011-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758se1-
047ltr.pdf 2004-06-01 00:00:00
1567 1 019758 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19758slr051ltr.pdf
2003-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s054ltr.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s056ltr.pdf
2005-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s059ltr.pdf
2008-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s
070ltr.pdf 2013-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s072ltr.pdf
2014-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s073ltr.pdf
2014-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s074ltr.pdf
2015-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466
Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf 2016-06-14
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019763Orig1s019ltr.pdf
2014-09-02 00:00:00
1577 14 019764 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1578 14 019764 SUPPL 25 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1579 14 019764 SUPPL 39 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1580 14 019764 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1581 1 019766 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf
2003-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s069ltr.pdf
2005-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s074ltr.pdf
2007-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s078ltr.pdf
2010-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s081ltr.pdf
2010-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s083ltr.pdf
2011-10-12 00:00:00
1587 1 019766 SUPPL 88 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088lt
r.pdf 2012-11-05 00:00:00
1588 1 019766 SUPPL 90 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019766Orig1s090ltr.pdf
2013-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019766Orig1s091ltr.pdf
2014-02-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019766Orig1s093ltr.pdf
2015-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19771slr022ltr.pdf
2003-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s028ltr.pdf
2006-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019771s032ltr.pdf
2009-05-26 00:00:00
1594 14 019774 SUPPL 14 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1595 14 019774 SUPPL 16 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1596 14 019774 SUPPL 27 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19777S37LTR.PDF
2000-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019777s049ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s052,
019888s043ltr.pdf 2007-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s053,
019888s044ltr.pdf 2007-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s054ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s057ltr.pdf
2014-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019777s058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s059ltr.pdf
2012-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s062ltr.pdf
2012-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019777Orig1s074ltr.pdf
2016-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19778s034ltr.pdf
2002-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019778s036ltr.pdf
2005-10-11 00:00:00
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019778s040LTR.pdf 2007-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042,
s043ltr.pdf 2008-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042,
s043ltr.pdf 2008-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19779SLR015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19779s018,019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19781ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019781s013,020843s010l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF
2000-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF
2000-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19787se5-
030ltr.pdf 2004-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19787slr031ltr.pdf
2003-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019787s037ltr.pdf
2005-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019787s042ltr.pdf
2007-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019787s047ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019796s020ltr.pdf
2005-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019796Orig1s026ltr.pdf
2013-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19797scf013ltr.pdf
2004-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019805s029ltr.pdf
2012-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19806slr008ltr.pdf
2004-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019807s001ltr.pdf
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058,slr003ltr.pdf 2004-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810s061ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19810s082ltr.pdf
2005-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056
Orig1s011ltr.pdf 2012-10-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056
Orig1s015ltr.pdf 2014-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19813S30ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019813s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19813se1-
036ltr.pdf 2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19813s039ltr.pdf
2005-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s063ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19815s5ltr.pdf
2002-03-20 00:00:00
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1645 14 019818 SUPPL 42 This Former NDA Was Deemed To Be a BLA on
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event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19821slr002,006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019821Orig1s027ltr.pdf
2015-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019822Orig1s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824
Orig1s023,020519Orig1s016ltr.pdf 2013-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019826s020ltr.pdf
2008-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019830Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19832ltr.pdf
1998-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_APPROV.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19834S017ltr.pdf
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Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf 2014-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915se5-
037ltr.pdf 2003-06-08 00:00:00
1811 1 019915 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019915s042,020286s008l
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1812 1 019918 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19918s9ltr.pdf
2002-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19922se5-
005ltr.pdf 2004-04-07 00:00:00
1814 1 019922 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019922Orig1s016ltr.pdf
2015-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19928slr002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19931slr008ltr.pdf
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1818 14 019938 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1819 14 019938 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1820 14 019938 SUPPL 63 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1821 14 019938 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1822 14 019938 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1823 14 019938 SUPPL 68 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1824 14 019938 SUPPL 69 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1825 1 019941 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019941s017ltr.pdf
2006-01-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019941s018LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
222420517181920708202120011tr.pdf 2005-10-20 00:00:00
1829 1 019943 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026,
020011s033, 020708s026ltr.pdf 2007-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943
Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf 2013-10-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,
020090s036ltr.pdf 2011-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,
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020090s038ltr.pdf 2011-11-21 00:00:00
1841 1 019950 SUPPL 62 0

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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19951s17ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s023LTR.pdf
2006-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019951s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19952slr012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019952Orig1s030ltr.pdf
2013-01-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019953slr012ltr.pdf
2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019953s021ltr.pdf
2009-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19958s08ltr.pdf
1999-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf
1999-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19958s13ltr.pdf
2002-04-16 00:00:00
1856 14 019959 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1857 14 019959 SUPPL 66 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1858 14 019959 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1859 14 019959 SUPPL 69 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1860 14 019959 SUPPL 70 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1861 14 019959 SUPPL 71 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1862 14 019959 SUPPL 73 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1863 14 019959 SUPPL 75 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1864 1 019962 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962slr024ltr.pdf
2003-01-30 00:00:00
1865 1 019962 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s027ltr.pdf
2005-02-17 00:00:00
1866 1 019962 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s033ltr.pdf
2007-07-24 00:00:00
1867 1 019962 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019962s038ltr.pdf
2009-03-02 00:00:00
1868 1 019962 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019962Orig1s043ltr.pdf
2012-11-05 00:00:00
1869 1 019963 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF
2000-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF
2000-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641s
lr016,018,19964slr011,014ltr.pdf 2003-03-25 00:00:00
1872 1 019964 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641s
lr016,018,19964slr011,014ltr.pdf 2003-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr025,19964slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019579Orig1s035,019641
s028,019964Orig1s030ltr.pdf 2013-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641
Orig1s030,019964Orig1s032ltr.pdf 2014-07-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19966slr008ltr.pdf
2003-04-18 00:00:00
1877 1 019967 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19967s010ltr.pdf
2004-09-17 00:00:00
1878 1 019968 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011l
tr.pdf 2012-04-04 00:00:00
1879 1 019970 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019970Orig1s015ltr.pdf
2014-10-03 00:00:00
1880 1 019976 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19979S18ltr.pdf
2001-04-18 00:00:00
1882 1 019983 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf
1998-12-23 00:00:00
1883 1 019983 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf
1998-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983s16ltr.pdf
2002-01-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983slr017ltr.pdf
2002-10-04 00:00:00
1886 14 019991 SUPPL 32 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1887 14 019991 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1888 14 019991 SUPPL 36 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1889 14 019991 SUPPL 70 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1890 14 019991 SUPPL 71 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
1891 14 019991 SUPPL 74 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19992s019ltr.pdf
2004-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019992s020ltr.pdf
2006-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019998s013ltr.pdf
2007-07-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20007s035ltr.pdf
2005-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020007Orig1s043ltr.pdf
2012-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20010slr003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20010slr005ltr.pdf
2003-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s015ltr.pdf
2008-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20011s21ltr.pdf
2001-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20013slr014ltr.pdf
2004-03-10 00:00:00
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2005-03-18 00:00:00
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2006-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20031s23ltr.pdf 1999-
05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.
pdf 2006-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059,
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1920 1 020031 SUPPL 59 0

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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020033Orig1s052ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia_appltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20036s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020036s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020037Orig1s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20038se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20049scs015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020051s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020051s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020051Orig1s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20059s7ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020062s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020064s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020064s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020065s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
066S010_Nicorette_Approv.pdf 2000-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18612slr031,%2020066sl
r013ltr.pdf 2002-08-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066scf016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018612s042,020066s023l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018612s050,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018612s052,020066s033l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018612Orig1s068,020066
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s074,020066
Orig1s055ltr.pdf 2014-11-03 00:00:00
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Orig1s057ltr.pdf 2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20152slr031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20152s033LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20152slr034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20152s035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020156s044ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020156s046,021183s023l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s047,021183s024l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020156Orig1s051ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020162Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s
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2112 1 020163 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163
Orig1s027,020183Orig1s026ltr.pdf 2015-09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S10_lovenox_approv.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20164s15ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S20LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S34ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S36ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr048ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr050ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr051ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20164s063ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020164s070ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s092ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s093ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020164Orig1s100ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20165slr020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020165s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20169s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018883s033,020171s015l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018883Orig1s044,020171
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018883Orig1s051,20171O
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018883Orig1s057,020171
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180se8-
026ltr.pdf 2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180slr029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020180s037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020180s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020180Orig1s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020180Orig1s044ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20181scs001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20182S6LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020184s013,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020184s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020184s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20189slr018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020193s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020193s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20198s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020198s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020198s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20199s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020204s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020204s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20212se7-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020212s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020213s010LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020214s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020214Orig1s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020215Orig1s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s059ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s060ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020216Orig1s081ltr.pdf
2015-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20220slr008ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020220s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020220s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020220Orig1s041,021425
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20221s12ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20221s15ltr.pdf
2002-02-20 00:00:00
2187 1 020231 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231s023ltr.pdf
2002-04-30 00:00:00
2188 1 020231 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231scp026ltr.pdf
2002-12-06 00:00:00
2189 1 020231 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231scf027ltr.pdf
2002-12-06 00:00:00
2190 1 020231 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scf028ltr.pdf
2003-10-16 00:00:00
2191 1 020231 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scp029ltr.pdf
2003-04-18 00:00:00
2192 1 020231 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scp032ltr.pdf
2003-12-02 00:00:00
2193 1 020231 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20231scf033ltr.pdf
2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20231s037ltr.pdf
2005-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020231s042ltr.pdf
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2196 1 020231 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020231s046ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s047ltr.pdf
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2198 1 020231 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s055ltr.pdf
2007-09-25 00:00:00
2199 1 020231 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s057ltr.pdf
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2200 1 020231 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s060ltr.pdf
2008-01-09 00:00:00
2201 1 020231 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020231Orig1s072,s073lt
r.pdf 2014-06-17 00:00:00
2202 1 020231 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020231Orig1s075ltr.pdf
2016-03-29 00:00:00
2203 1 020232 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020232s021ltr.pdf
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2204 1 020232 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s035ltr.pdf
2013-05-13 00:00:00
2205 1 020232 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s036ltr.pdf
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2206 1 020234 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF
2001-03-07 00:00:00
2207 1 020234 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098,
018281s046, 018927s039, 020234s028_ltr.pdf 2008-01-09 00:00:00
2208 1 020234 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281
s049,s050,018927s041,s042,020234s031,s033ltr.pdf 2011-03-07 00:00:00
2209 1 020234 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281
Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf 2014-01-17 00:00:00
2210 1 020234 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,01828
1Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf 2013-03-08 00:00:00
2211 1 020234 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281
Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf 2012-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf
2002-01-30 00:00:00
2213 1 020235 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-
023,20882se8-009,21129se8-010ltr.pdf 2004-06-10 00:00:00
2214 1 020235 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21
129s016ltr.pdf 2005-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035,
020882s021, 021129s020LTR.pdf 2006-05-05 00:00:00
2216 1 020235 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020235s041,020882s028l
tr.pdf 2009-05-01 00:00:00
2217 1 020235 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,
021129s033ltr.pdf 2011-08-12 00:00:00
2218 1 020235 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s
056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 2013-05-07
00:00:00
2219 1 020235 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882
Orig1s041,021129Orig1s039ltr.pdf 2014-08-20 00:00:00
2220 1 020235 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882
s043,021129Orig1s042ltr.pdf 2015-09-17 00:00:00
2221 1 020237 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf
2004-06-07 00:00:00
2222 1 020237 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20237s007_Salagen_appltr.pdf
1998-02-11 00:00:00
2223 1 020237 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf
2002-06-10 00:00:00
2224 1 020238 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020238s013ltr.pdf
2005-05-17 00:00:00
2225 1 020238 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020238s017ltr.pdf
2008-02-13 00:00:00
2226 1 020239 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s015ltr.pdf
2004-08-25 00:00:00
2227 1 020239 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020239s018ltr.pdf
2005-11-30 00:00:00
2228 1 020239 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,
021238s007ltr.pdf 2009-11-12 00:00:00
2229 1 020239 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020239s023ltr.pdf
2011-09-19 00:00:00
2230 1 020241 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s3ltr.pdf
1998-12-14 00:00:00
2231 1 020241 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20241se8-
016,20764se8-009ltr.pdf 2004-01-22 00:00:00
2232 1 020241 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
2233 1 020241 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
2234 1 020241 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
2235 1 020241 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764
Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf 2013-12-26 00:00:00
2236 1 020241 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764
s036,s037,022251s005,s006ltr.pdf 2010-11-03 00:00:00
2237 1 020241 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,02
0764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 2015-03-25
00:00:00
2238 1 020241 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,
022251s011ltr.pdf 2011-06-02 00:00:00
2239 1 020241 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,02
0764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 2015-03-25
00:00:00
2240 1 020246 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20246scs019ltr.pdf
2003-06-08 00:00:00
2241 1 020246 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20246s025ltr.pdf
2004-12-02 00:00:00
2242 1 020246 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020246s036ltr.pdf
2010-10-19 00:00:00
2243 1 020246 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s053ltr.pdf
2015-02-02 00:00:00
2244 1 020249 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF
2001-03-14 00:00:00
2245 1 020250 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20250slr007,008ltr.pdf
2002-08-01 00:00:00
2246 1 020251 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20251scf015ltr.pdf
2004-04-07 00:00:00
2247 1 020251 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,
020251s016ltr.pdf 2005-05-02 00:00:00
2248 1 020251 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066,
019675s032, 020251s017_ltr.pdf 2006-07-21 00:00:00
2249 1 020251 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,
020251s018ltr.pdf 2009-02-19 00:00:00
2250 1 020254 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_
019201s035ltr.pdf 2006-01-30 00:00:00
2251 1 020254 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf
2011-02-28 00:00:00
2252 1 020255 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf
2003-07-28 00:00:00
2253 1 020255 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020255s014ltr.pdf
2012-03-12 00:00:00
2254 1 020261 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_che
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2255 1 020261 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S24ltr.pdf
2000-10-23 00:00:00
2256 1 020261 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S25ltr.pdf
2000-12-18 00:00:00
2257 1 020261 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr00
4ltr.pdf 2002-09-06 00:00:00
2258 1 020261 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-
033,21192se1-005ltr.pdf 2003-06-08 00:00:00
2259 1 020261 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035,
s036, 021192s010, s011ltr.pdf 2006-04-13 00:00:00
2260 1 020261 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039,
021192s013ltr.pdf 2007-06-14 00:00:00
2261 1 020261 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016l
tr.pdf 2011-06-28 00:00:00
2262 1 020261 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192
s021ltr.pdf 2012-11-05 00:00:00
2263 1 020262 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf
1998-04-09 00:00:00
2264 1 020262 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20262slr041ltr.pdf
2003-03-26 00:00:00
2265 1 020263 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20263scs020ltr.pdf
2002-09-24 00:00:00
2266 1 020263 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020263s028ltr.pdf
2006-02-22 00:00:00
2267 1 020263 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020263s030ltr.pdf
2008-08-05 00:00:00
2268 1 020263 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020263Orig1s039ltr.pdf
2013-05-16 00:00:00
2269 1 020264 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20264s9ltr.pdf
2002-04-09 00:00:00
2270 1 020264 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20264slr011ltr.pdf
2003-05-30 00:00:00
2271 1 020264 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020264s017ltr.pdf
2012-04-11 00:00:00
2272 1 020267 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020267s010ltr.pdf
2006-01-20 00:00:00
2273 1 020272 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20588s05ltr.pdf
2004-06-16 00:00:00
2274 1 020272 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272slr024,20588slr01
5ltr.pdf 2002-11-19 00:00:00
2275 1 020272 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-
26,27,20588se1-017,018,21444se1-002,003ltr.pdf 2003-12-11 00:00:00
2276 1 020272 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr02
3,21444slr007ltr.pdf 2003-11-25 00:00:00
2277 1 020272 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s
37,21444s20s21ltr.pdf 2007-08-22 00:00:00
2278 1 020272 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,
021346s027,021444s029ltr.pdf 2008-08-19 00:00:00
2279 1 020272 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062
,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 2010-09-07 00:00:00
2280 1 020272 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,
021346s033,021444s031ltr.pdf 2009-08-06 00:00:00
2281 1 020272 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062
,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 2010-09-07 00:00:00
2282 1 020272 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,
021346s040,021444s039ltr.pdf 2010-12-06 00:00:00
2283 1 020273 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20273s4ltr.pdf
1999-07-07 00:00:00
2284 1 020273 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,
020273s009ltr.pdf 2007-10-04 00:00:00
2285 1 020273 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273O
rig1s13ltr.pdf 2015-03-13 00:00:00
2286 1 020279 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020279s009ltr.pdf
2010-12-10 00:00:00
2287 14 020280 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2288 14 020280 SUPPL 40 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2289 14 020280 SUPPL 44 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2290 14 020280 SUPPL 60 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2291 14 020280 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2292 14 020280 SUPPL 71 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2293 1 020281 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20281slr030,21123slr00
1ltr.pdf 2004-04-20 00:00:00
2294 1 020286 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019915s042,020286s008l
tr.pdf 2009-02-13 00:00:00
2295 1 020287 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20287s8ltr.pdf
1999-03-30 00:00:00
2296 1 020287 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr011ltr.pdf
2003-03-10 00:00:00
2297 1 020287 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20287S18LTR.PDF
2000-08-03 00:00:00
2298 1 020287 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf
2002-04-04 00:00:00
2299 1 020287 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287slr027LTR.pdf
2002-11-01 00:00:00
2300 1 020287 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr031ltr.pdf
2003-07-06 00:00:00
2301 1 020287 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20287slr034ltr.pdf
2004-04-29 00:00:00
2302 1 020287 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020287s035ltr.pdf
2007-05-07 00:00:00
2303 1 020291 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s026ltr.pdf
2009-05-13 00:00:00
2304 1 020297 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
297S007_Coreg_Approv.pdf 2001-11-01 00:00:00
2305 1 020297 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297se1-
009ltr.pdf 2003-03-28 00:00:00
2306 1 020297 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s013ltr.pdf
2005-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s017ltr.pdf
2005-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s020_ltr.pdf
2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020297s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020297s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020301Orig1s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020304s022ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020305s010,021238s005l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20312S16ltr.pdf
2001-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20313scs023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20316slr016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020316s021LTR.pdf
2006-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020316Orig1s028ltr.pdf
2015-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s3ltr.pdf
2002-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s13ltr.pdf
2002-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020325Orig1s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020326s015ltr.pdf
2005-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020329s022ltr.pdf
2008-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020329s025ltr.pdf
2011-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020329Orig1s029ltr.pdf
2015-10-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20330slr017ltr.pdf
2003-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20330s018,019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20330s018,019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020330s022,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020330Orig1s029ltr.pdf
2015-10-13 00:00:00
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1998-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020333s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s019ltr.pdf
2011-11-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s021ltr.pdf
2014-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20334slr001ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020334Orig1s008ltr.pdf
2013-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020334Orig1s009ltr.pdf
2015-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019546s031,020336s013l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20340slr006ltr.pdf
2003-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19436slr019,20343slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20346s002ltr.pdf
1998-05-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019057Orig1s021,020347
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20351scm010ltr.pdf
2004-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351slr013ltr.pdf
2003-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020353s023ltr.pdf
2009-08-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020355s013ltr.pdf
2011-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s017ltr.pdf
2013-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20357s10ltr.pdf
1998-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20357S19LTR.PDF
2000-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020357s031,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s022,023and20358s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr026,20358slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,
020358s046,020358s047ltr.pdf 2009-07-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s041,020358s048l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018644Orig1s044,020358
Orig1s051ltr.pdf 2012-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s045,020358
Origs052ltr.pdf 2013-03-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;0
20358Orig1s053,s054ltr.pdf 2013-12-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s049,020358
Orig1s056ltr.pdf 2014-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf
1998-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf
1998-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027,
020363s028LTR.pdf 2006-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf
2012-02-13 00:00:00
2390 1 020363 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020363Orig1s042ltr.pdf
2013-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20364slr014ltr.pdf
2003-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364s028ltr.pdf
2004-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s036ltr.pdf
2007-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s048ltr.pdf
2010-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s054ltr.pdf
2011-10-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367s053ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367slr055ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20369ltr.pdf
1998-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.
pdf 2003-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf
2004-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_Approv.pdf
2001-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372se1-
013ltr.pdf 2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372slr015ltr.pdf
2003-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_appltr.pdf
1998-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf
1999-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S14ltr.pdf
2001-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S16ltr.pdf
2001-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20375slr020ltr.pdf
2004-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20375s021ltr.pdf
2005-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020375s022ltr.pdf
2005-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020375s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20377s4s5ltr.pdf
2001-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr010,012ltr.pdf
2003-05-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s017ltr.pdf
2004-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020377s018ltr.pdf
2005-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020377s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20378S6LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20378scf015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20379s11ltr.pdf
2002-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020379Orig1s030ltr.pdf
2016-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381s07ltr.pdf
1999-09-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s020ltr.pdf
2005-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s023ltr.pdf
2005-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s027ltr.pdf
2007-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s034ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s038ltr.pdf
2009-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf
2009-11-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020381Orig1s048,022078
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020381Orig1s051ltr.pdf
2015-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20385slr006,20714slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20385s007,20714s012ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20386se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20386se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020386Orig1s054ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020386Orig1s057ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020386Orig1s058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s060ltr_rep
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s061ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020387s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s038LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020387Orig1s047ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020387s048ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020387Orig1s057ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020387Orig1s060ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
388S008_Navelbine_Approv.pdf 2000-06-08 00:00:00
2464 1 020388 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20388s10ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20388se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020388Orig1s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20392slr007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20393ltr.pdf
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2469 1 020393 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020393s007,020394s008l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020393s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20394s01ltr.pdf
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2473 1 020394 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020394s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020397s021,
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20400_appltrs.pdf 1998-
01-29 00:00:00
2476 1 020401 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020401s034ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20402slr011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s016LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020402s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020402s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020402Orig1s040ltr.pdf
2015-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020405s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020405Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020405s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20406S021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406slr056ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022,
020406s065, 021428s013ltr.pdf 2008-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067,
021281s024, 021428s017ltr.pdf 2008-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s074,021428s021l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20408s25ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20409S6LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s029,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s030,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s032,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020415s019,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20428slr016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20430s3ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20441s12ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020444s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020444s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20449se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20449s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s034ltr.pdf
2005-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449S035ltr.pdf
2006-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s059ltr.pdf
2010-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s064ltr.pdf
2011-09-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s065ltr.pdf
2011-12-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s071ltr.pdf
2013-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020449Orig1s073ltr.pdf
2014-11-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019
ltr.pdf 2011-11-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s024ltr.pdf
2013-10-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020450Orig1s029ltr.pdf
2016-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451sap.pdf
1998-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451s3ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020451s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020451s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20452ltr.pdf
2003-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20452scs001ltr.pdf
2004-01-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020457Orig1s014ltr.pdf
2015-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020459s006ltr.pdf
2006-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20463S2LTR.PDF
2001-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr012ltr.pdf
2004-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20468slr013ltr.pdf
2004-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020468s024ltr.pdf
2008-09-23 00:00:00
2570 1 020468 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020468Orig1s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20470s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020472Orig1s012,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20474slr016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020474s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20478S6LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020478s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20479slr005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose_appltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020482s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020482s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020482s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020482Orig1s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20484ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20484slr003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020484s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20485s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020487s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020489s013LTR.pdf
2006-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020489Orig1s031ltr.pdf
2014-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020490Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s01ltr.pdf 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf 2001-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020497s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020498s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020500s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020500Orig1s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20503s11ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020503s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020503s046ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr020,20844slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s042,20844s36ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s054,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s055,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20509ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20509s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20509se1-
029ltr.pdf 2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s033ltr.pdf
2005-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s037ltr.pdf
2006-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s075ltr.pdf
2014-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20511s002ltr.pdf
2002-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-
603S002_Ibuprofen_Approv.pdf 1999-09-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20516s016ltr.pdf
2005-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020516s018ltr.pdf
2005-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020516s020LTR.pdf
2006-06-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020516s021ltr.pdf
2009-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020516Orig1s029ltr.pdf
2014-12-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020516Orig1s030ltr.pdf
2015-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,
s035,s036,020517s024,s028,s029ltr.pdf 2010-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032lt
r.pdf 2011-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032lt
r.pdf 2011-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020517Origs033ltr.pdf
2012-07-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517
Orig1s035,019732Orig1s000ltr.pdf 2013-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf
2002-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041,
019910s029, 020518s013LTR.pdf 2006-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020518s015ltr.pdf
2006-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033,
019655s046, 020518s016ltr.pdf 2008-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20519slr005ltr.pdf
2003-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824
Orig1s023,020519Orig1s016ltr.pdf 2013-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20520s015ltr.pdf
2005-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20521scm008ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20524S5ltr.pdf
2001-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527s017ltr.pdf
2003-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-
024,slr026,slr031ltr.pdf 2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527slr030ltr.pdf
2003-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-
024,slr026,slr031ltr.pdf 2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf
2004-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020527s037ltr.pdf
2006-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020527s043ltr.pdf
2008-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s
056ltr.pdf 2012-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s
056ltr.pdf 2012-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s
056ltr.pdf 2012-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020527Orig1s062ltr.pdf
2015-09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20528slr008ltr.pdf
2004-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020528s012ltr.pdf
2010-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s017ltr.pdf
2011-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s018ltr.pdf
2012-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20533s012ltr.pdf
2004-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf
2010-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020533Orig1s026ltr.pdf
2014-10-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_appltr.pdf
1999-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf
2002-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf
2002-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf
2002-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s
030ltr.pdf 2013-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020538Orig1s032ltr.pdf
2014-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20539slr012ltr.pdf
2004-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020539s017ltr.pdf
2010-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s018ltr.pdf
2011-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020539s021ltr.pdf
2012-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s023ltr.pdf
2013-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20541S06LTR.PDF
2000-09-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20541s015ltr.pdf
2004-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020541s016ltr.pdf
2005-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf
2009-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020541Orig1s027ltr.pdf
2013-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20547s07ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20547s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20550se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20551s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020551s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020552s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020552s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20555s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_appltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560slr028ltr.pdf
2002-09-16 00:00:00
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%20ltr.pdf 2003-07-24 00:00:00
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1999-07-02 00:00:00
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5ltr.pdf 2002-11-19 00:00:00
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26,27,20588se1-017,018,21444se1-002,003ltr.pdf 2003-12-11 00:00:00
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2794 1 020588 SUPPL 46 0

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2796 1 020588 SUPPL 49 0

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2797 1 020588 SUPPL 53 0

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Orig1s053,021444Orig1s041ltr.pdf 2012-08-03 00:00:00
2798 1 020588 SUPPL 54 0

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2008-03-04 00:00:00
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018ltr.pdf 2003-07-28 00:00:00
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021253s015ltr.pdf 2005-09-15 00:00:00
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s034,s032,021253s043,s039ltr.pdf 2010-06-03 00:00:00
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18936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 2013-
07-30 00:00:00
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18723s024,19680s015,20593s009,2116 2004-06-02 00:00:00
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2016-04-11 00:00:00
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2009-05-04 00:00:00
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603S001_Ibuprofen_Approv.pdf 1998-06-12 00:00:00
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603S002_Ibuprofen_Approv.pdf 1999-09-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20603s5ltr.pdf
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2854 14 020604 SUPPL 27 This Former NDA Was Deemed To Be a BLA on
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event=faq.page#nda_bla 2020-03-23 00:00:00
2855 14 020604 SUPPL 29 This Former NDA Was Deemed To Be a BLA on
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event=faq.page#nda_bla 2020-03-23 00:00:00
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2858 14 020604 SUPPL 44 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2859 14 020604 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
2860 1 020605 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20781S2LTR.PDF
2000-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20
781s007ltr.pdf 2004-12-02 00:00:00
2862 1 020605 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,
020781s013ltr.pdf 2010-09-27 00:00:00
2863 1 020605 SUPPL 18 0

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Orig1s018,020781Orig1s018ltr.pdf 2014-09-23 00:00:00
2864 1 020607 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020607s008ltr.pdf
2005-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020607s009ltr.pdf
2006-01-30 00:00:00
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2009-11-10 00:00:00
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2013-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020607Orig1s028ltr.pdf
2014-09-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20610s001ltr.pdf
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2007-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020610s018ltr.pdf
2008-07-14 00:00:00
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2005-05-02 00:00:00
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020273s009ltr.pdf 2007-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20612ltr.pdf
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2010-04-19 00:00:00
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2015-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine
%20Tartrate%20Ophthalmic_Approv.pdf 2001-12-20 00:00:00
2881 1 020613 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020613Orig1s031ltr.pdf
2016-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017,
s021ltr.pdf 2007-03-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020616s022ltr.pdf
2006-11-06 00:00:00
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2013-03-29 00:00:00
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2014-04-17 00:00:00
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2014-08-20 00:00:00
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2015-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s055ltr.pdf
2016-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622s23ltr.pdf
2002-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622slr026ltr.pdf
2002-08-29 00:00:00
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2014-01-29 00:00:00
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2005-06-07 00:00:00
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2009-11-10 00:00:00
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021721s009ltr.pdf 2007-09-25 00:00:00
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021721s011ltr.pdf 2007-09-25 00:00:00
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047020635se5-051021721se5-015ltr.pdf 2008-05-08 00:00:00
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021721s017ltr.pdf 2007-11-19 00:00:00
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020635s054, 021721s018ltr.pdf 2008-01-09 00:00:00
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021721s022ltr.pdf 2009-03-13 00:00:00
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021721s025ltr.pdf 2011-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,
021721s026ltr.pdf 2011-06-14 00:00:00
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Orig1s071,021721Orig1s032ltr_replace.pdf 2013-08-16 00:00:00
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2004-05-26 00:00:00
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020933s017ltr.pdf 2008-06-30 00:00:00
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tr.pdf 2010-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s028,020636s037l
tr.pdf 2011-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s039,020933s030l
tr.pdf 2011-11-14 00:00:00
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016ltr.pdf 2003-03-10 00:00:00
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017,016ltr.pdf 2004-01-14 00:00:00
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021ltr.pdf 2009-03-10 00:00:00
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Orig1s032ltr.pdf 2014-06-11 00:00:00
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020658s021ltr.pdf 2009-01-06 00:00:00
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3017 1 020659 SUPPL 26 0
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2001-03-06 00:00:00
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.pdf 2005-03-30 00:00:00
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2008-05-20 00:00:00
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tr.pdf 2012-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022417Orig1s008,020659
Orig1s057ltr.pdf 2012-11-23 00:00:00
3027 1 020659 SUPPL 60 0

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Orig1s060ltr.pdf 2015-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s013,020659
Orig1s061ltr.pdf 2015-04-03 00:00:00
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016,21283se1-001ltr.pdf 2002-08-14 00:00:00
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r.pdf 2014-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s037ltr.pdf
2014-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667a_appltr.pdf
1997-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,
020667s018ltr.pdf 2009-01-06 00:00:00
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020667s018ltr.pdf 2009-01-06 00:00:00
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022,s023,s024ltr.pdf 2012-07-18 00:00:00
3042 1 020667 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s
022,s023,s024ltr.pdf 2012-07-18 00:00:00
3043 1 020667 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s
022,s023,s024ltr.pdf 2012-07-18 00:00:00
3044 1 020667 SUPPL 29 0

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2015-04-03 00:00:00
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2016-08-01 00:00:00
3047 1 020668 SUPPL 3 0
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668S003_Lexxel_Approv.pdf 1998-10-28 00:00:00
3048 1 020668 SUPPL 5 0

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2007-10-10 00:00:00
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2003-06-08 00:00:00
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4slr010,011ltr.pdf 2002-07-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and2073
4slr010,011ltr.pdf 2002-07-25 00:00:00
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3070 1 020685 SUPPL 55 0

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2008-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020685s069ltr.pdf
2009-11-19 00:00:00
3078 1 020685 SUPPL 71 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020685s071ltr.pdf
2010-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15others
ltr.pdf 2011-06-17 00:00:00
3080 1 020685 SUPPL 76 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020685Orig1s076ltr.pdf
2014-07-28 00:00:00
3081 1 020685 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020685Orig1s077ltr.pdf
2015-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s010ltr.pdf
2004-11-15 00:00:00
3083 1 020687 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020687s013ltr.pdf
2005-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020687Orig1s020ltr.pdf
2016-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20688slr016ltr.pdf
2003-05-29 00:00:00
3086 1 020690 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,
021720s006ltr.pdf 2010-11-30 00:00:00
3087 1 020690 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,
021720s008ltr_corrected.pdf 2012-03-05 00:00:00
3088 1 020692 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf
1998-09-25 00:00:00
3089 1 020692 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20692s016ltr.pdf
2002-03-22 00:00:00
3090 1 020692 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028,
021077s027ltr.pdf 2007-03-01 00:00:00
3091 1 020692 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029l
tr.pdf 2006-03-23 00:00:00
3092 1 020692 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s032ltr.pdf
2011-01-04 00:00:00
3093 1 020692 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,
020692s036ltr.pdf 2010-06-29 00:00:00
3094 1 020692 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,
020692s039ltr.pdf 2011-07-05 00:00:00
3095 1 020697 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20697ltr.pdf
1998-01-29 00:00:00
3096 1 020697 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020697Orig1s004ltr.pdf
2013-05-14 00:00:00
3097 1 020697 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020697s010ltr.pdf
2006-03-01 00:00:00
3098 1 020697 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s013,020697s015l
tr.pdf 2009-02-13 00:00:00
3099 1 020697 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s016ltr.pdf
2009-07-07 00:00:00
3100 1 020699 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20699s1ltr.pdf
1999-03-11 00:00:00
3101 1 020699 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf
2003-07-30 00:00:00
3102 1 020699 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr032ltr.pdf
2003-03-10 00:00:00
3103 1 020699 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf
2003-09-09 00:00:00
3104 1 020699 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20699slr045ltr.pdf
2004-03-19 00:00:00
3105 1 020699 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020699s047ltr.pdf
2008-01-09 00:00:00
3106 1 020699 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20
699slr041,048,052ltr.pdf 2004-05-26 00:00:00
3107 1 020699 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf
2005-11-22 00:00:00
3108 1 020699 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s034,020699s056l
tr.pdf 2006-03-01 00:00:00
3109 1 020699 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf
2005-11-22 00:00:00
3110 1 020699 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s
062s064ltr.pdf 2006-01-20 00:00:00
3111 1 020699 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020699s066ltr.pdf
2006-03-23 00:00:00
3112 1 020699 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s067ltr.pdf
2008-02-05 00:00:00
3113 1 020699 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s043,
020699s069ltr.pdf 2007-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s044,
020699s071ltr.pdf 2006-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s045,
020699s072ltr.pdf 2006-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s
77,s79ltr.pdf 2007-09-25 00:00:00
3117 1 020699 SUPPL 81 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081,
020151s051ltr.pdf 2008-05-28 00:00:00
3118 1 020699 SUPPL 106 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020699Orig1s106ltr.pdf
2016-03-02 00:00:00
3119 1 020701 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20701S9ltr.pdf
2001-04-23 00:00:00
3120 1 020701 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr011,20756slr01
2ltr.pdf 2003-09-29 00:00:00
3121 1 020701 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20701s014ltr.pdf
2005-03-29 00:00:00
3122 1 020701 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023lt
r.pdf 2011-12-14 00:00:00
3123 1 020701 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023lt
r.pdf 2011-12-14 00:00:00
3124 1 020702 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20702ltrs003s005.pdf
1998-07-10 00:00:00
3125 1 020702 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702s029s034.pdf
2002-04-22 00:00:00
3126 1 020702 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702s029s034.pdf
2004-06-08 00:00:00
3127 1 020702 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20702slr036ltr.pdf
2003-06-08 00:00:00
3128 1 020702 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020702s042ltr.pdf
2005-10-20 00:00:00
3129 1 020702 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020702s043ltr.pdf
2005-10-14 00:00:00
3130 1 020702 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020702s044LTR.pdf
2006-08-09 00:00:00
3131 1 020702 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020702s046LTR.pdf
2006-06-27 00:00:00
3132 1 020702 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020702s056ltr.pdf
2010-11-05 00:00:00
3133 1 020702 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702Orig1s062,s063lt
r.pdf 2012-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702Orig1s062,s063lt
r.pdf 2012-11-05 00:00:00
3135 1 020702 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020702Orig1s065ltr.pdf
2015-03-13 00:00:00
3136 1 020704 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-
018,20704se6-008,20641se6-009ltr.pdf 2002-11-27 00:00:00
3137 1 020704 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020704s020ltr.pdf
2008-10-23 00:00:00
3138 1 020704 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020704s021ltr.pdf
2009-02-03 00:00:00
3139 1 020704 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993
Orig1s012ltr.pdf 2014-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20705s9ltr.pdf
2002-03-14 00:00:00
3141 1 020705 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020705s010ltr.pdf
2006-04-13 00:00:00
3142 1 020705 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020705Orig1s018ltr.pdf
2012-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20706slr011ltr.pdf
2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020707s005ltr.pdf
2006-11-22 00:00:00
3145 1 020708 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5_appltr.pdf
1999-02-11 00:00:00
3146 1 020708 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20708s11ltr.pdf
2001-09-21 00:00:00
3147 1 020708 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr02
5,20708slr015ltr.pdf 2004-01-22 00:00:00
3148 1 020708 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
222420517181920708202120011tr.pdf 2005-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026,
020011s033, 020708s026ltr.pdf 2007-11-08 00:00:00
3150 1 020708 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020708s030ltr.pdf
2010-11-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,
020011s038ltr.pdf 2012-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020708s032ltr.pdf
2011-06-16 00:00:00
3153 1 020708 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943
Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf 2013-10-31 00:00:00
3154 1 020710 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf
2006-02-08 00:00:00
3155 1 020710 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s
23s30s31,20710s18s19ltr.pdf 2006-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710
s022,s030,020936s034,s044ltr.pdf 2011-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060,
020936s037, 020710s024ltr.pdf 2008-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020
710s026s029s033,020936s040s043ltr.pdf 2011-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020
710s026s029s033,020936s040s043ltr.pdf 2011-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710
s022,s030,020936s034,s044ltr.pdf 2011-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710
Orig1s031,020936Orig1s045ltr.pdf 2012-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,
020936s046ltr.pdf 2012-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,01
8ltr.pdf 2004-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,01
8ltr.pdf 2004-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf
2004-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21
515s009,20711s021ltr.pdf 2005-01-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf
2011-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020711s028ltr.pdf
2007-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf
2009-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s034ltr.pdf
2010-03-03 00:00:00
3171 1 020711 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf
2011-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020711s036ltr.pdf
2012-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s039ltr.pdf
2014-03-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s024ltr.pdf
2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s025LTR.pdf
2006-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020712s029ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s031ltr.pdf
2011-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035lt
r.pdf 2013-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035lt
r.pdf 2013-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020713Orig1s010ltr.pdf
2012-07-20 00:00:00
3181 1 020714 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20714slr010ltr.pdf
2002-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20715s3ltr.pdf
2002-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020715s016,
021288s013ltr.pdf 2008-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,
022437s002ltr.pdf 2011-01-20 00:00:00
3185 1 020716 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020716s008ltr.pdf
2006-11-06 00:00:00
3186 1 020716 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020716s010ltr.pdf
2008-07-31 00:00:00
3187 1 020716 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020716Orig1s011ltr.pdf
2012-08-29 00:00:00
3188 1 020717 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scp006ltr.pdf
2003-05-29 00:00:00
3189 1 020717 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20717se1-
008ltr.pdf 2004-02-02 00:00:00
3190 1 020717 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scf009ltr.pdf
2003-08-15 00:00:00
3191 1 020717 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036lt
r.pdf 2010-10-25 00:00:00
3192 1 020717 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038lt
r.pdf 2015-01-20 00:00:00
3193 1 020717 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875
s016,s017ltr.pdf 2012-01-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875
s016,s017ltr.pdf 2012-01-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20718ltr.pdf
1998-05-18 00:00:00
3196 1 020718 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf
2001-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20718se8-
017ltr.pdf 2003-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20718s022ltr.pdf
2004-07-21 00:00:00
3199 1 020718 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020718s025ltr.pdf
2005-10-14 00:00:00
3200 1 020718 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020718s034ltr.pdf
2011-04-04 00:00:00
3201 1 020718 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020718Orig1s037ltr.pdf
2013-03-26 00:00:00
3202 1 020723 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr010ltr.pdf
2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723se1-
015ltr.pdf 2004-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723s016ltr.pdf
2004-07-21 00:00:00
3205 1 020723 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020723s022ltr.pdf
2010-10-19 00:00:00
3206 14 020725 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3207 14 020725 SUPPL 3 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3208 14 020725 SUPPL 6 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3209 14 020725 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3210 14 020725 SUPPL 8 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3211 14 020725 SUPPL 11 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3212 1 020726 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726s8ltr.pdf
2004-06-04 00:00:00
3213 1 020726 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020726s012rev2.pdf
2006-01-06 00:00:00
3214 1 020726 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020726s014LTR.pdf
2007-04-20 00:00:00
3215 1 020726 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf
2010-03-08 00:00:00
3216 1 020726 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s020ltr.pdf
2010-05-06 00:00:00
3217 1 020727 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020727ltr.pdf
2005-06-24 00:00:00
3218 1 020727 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020727Orig1s005ltr.pdf
2015-04-03 00:00:00
3219 1 020729 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20729s10ltr.pdf
2002-02-14 00:00:00
3220 1 020729 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025l
tr.pdf 2012-01-23 00:00:00
3221 1 020732 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf
2002-10-08 00:00:00
3222 1 020732 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003L
TR.pdf 2006-10-13 00:00:00
3223 1 020732 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf
2012-01-03 00:00:00
3224 1 020732 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733
Orig1s017,022410Orig1s025ltr.pdf 2016-07-12 00:00:00
3225 1 020733 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf
2002-10-08 00:00:00
3226 1 020733 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003L
TR.pdf 2006-10-13 00:00:00
3227 1 020733 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020733Orig1s014ltr.pdf
2014-12-12 00:00:00
3228 1 020733 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733
Orig1s016ltr.pdf 2015-09-24 00:00:00
3229 1 020734 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20734S03LTR.PDF
2000-04-12 00:00:00
3230 1 020734 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and2073
4slr010,011ltr.pdf 2002-07-25 00:00:00
3231 1 020734 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20678scs013,20734scs01
2ltr.pdf 2003-06-08 00:00:00
3232 1 020734 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20678slr014,20734slr01
3ltr.pdf 2004-02-02 00:00:00
3233 1 020734 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020734s019ltr.pdf
2010-01-20 00:00:00
3234 1 020738 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr00
2ltr.pdf 2003-10-17 00:00:00
3235 1 020740 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF
2000-07-23 00:00:00
3236 1 020740 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF
2000-07-23 00:00:00
3237 1 020741 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741s12ltr.pdf
2002-01-18 00:00:00
3238 1 020741 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741scp019ltr.pdf
2003-10-17 00:00:00
3239 1 020741 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20741s022ltr.pdf
2005-02-11 00:00:00
3240 1 020741 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020741s030LTR.pdf
2006-06-28 00:00:00
3241 1 020741 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020741s034ltr.pdf
2008-07-15 00:00:00
3242 1 020741 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020741s035ltr.pdf
2009-06-16 00:00:00
3243 1 020741 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020741s038ltr.pdf
2010-08-03 00:00:00
3244 1 020741 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020741s040ltr.pdf
2012-03-05 00:00:00
3245 1 020742 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742scp004ltr.pdf
2003-05-29 00:00:00
3246 1 020742 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.
pdf 2004-05-26 00:00:00
3247 1 020743 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20743slr002ltr.pdf
2003-04-18 00:00:00
3248 1 020743 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20743scp006ltr.pdf
2004-07-06 00:00:00
3249 14 020744 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3250 1 020746 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746slr013ltr.pdf
2004-01-22 00:00:00
3251 1 020746 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s016ltr.pdf
2004-08-02 00:00:00
3252 1 020746 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020746s021ltr.pdf
2007-10-22 00:00:00
3253 1 020746 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020746s024ltr.pdf
2009-05-29 00:00:00
3254 1 020746 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s033ltr.pdf
2016-03-14 00:00:00
3255 1 020747 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20747ltr.pdf
1998-11-04 00:00:00
3256 1 020747 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20747scm008ltr.pdf
2003-02-19 00:00:00
3257 1 020747 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s10ltr.pdf
2002-03-07 00:00:00
3258 1 020747 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s011ltr.pdf
2002-06-10 00:00:00
3259 1 020747 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20747s017ltr.pdf
2004-09-29 00:00:00
3260 1 020747 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020747s030ltr.pdf
2010-01-20 00:00:00
3261 1 020752 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20752ltr.pdf
1998-05-28 00:00:00
3262 1 020753 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20753LTR.PDF
1999-10-21 00:00:00
3263 1 020753 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20753slr003ltr.pdf
2003-11-25 00:00:00
3264 1 020753 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020753s006ltr.pdf
2005-10-11 00:00:00
3265 1 020753 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr
.pdf 2011-03-28 00:00:00
3266 1 020753 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020753Orig1s014ltr.pdf
2013-02-20 00:00:00
3267 1 020753 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016lt
r.pdf 2014-05-06 00:00:00
3268 1 020755 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr00
5,21212slr002ltr.pdf 2003-09-09 00:00:00
3269 1 020756 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S9ltr.pdf
2001-04-11 00:00:00
3270 1 020757 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757se1-
021ltr.pdf 2002-09-20 00:00:00
3271 1 020757 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757scm022ltr.pdf
2002-07-19 00:00:00
3272 1 020757 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s038LTR.pdf
2006-04-25 00:00:00
3273 1 020757 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s056ltr.pdf
2011-12-14 00:00:00
3274 1 020757 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s058ltr.pdf
2012-01-23 00:00:00
3275 1 020758 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20758s032ltr.pdf
2005-03-18 00:00:00
3276 1 020758 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020758s036LTR.pdf
2006-04-25 00:00:00
3277 1 020758 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf
2011-06-09 00:00:00
3278 1 020758 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758Orig1s064ltr.pdf
2012-10-29 00:00:00
3279 1 020758 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020758Orig1s067ltr.pdf
2014-06-02 00:00:00
3280 1 020762 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20762s007ltr.pdf
2004-08-31 00:00:00
3281 1 020762 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20762slr014ltr.pdf
2003-03-10 00:00:00
3282 1 020762 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020762s038ltr.pdf
2010-06-02 00:00:00
3283 1 020763 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s
010ltr.pdf 2013-10-18 00:00:00
3284 1 020763 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf
2012-03-05 00:00:00
3285 1 020764 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20764ltr.pdf
1998-08-24 00:00:00
3286 1 020764 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s3ltr.pdf
1998-12-14 00:00:00
3287 1 020764 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20241se8-
016,20764se8-009ltr.pdf 2004-01-22 00:00:00
3288 1 020764 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
3289 1 020764 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
3290 1 020764 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s
028s033,022115s004s014,022251s002s009ltr.pdf 2015-01-07 00:00:00
3291 1 020764 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020764s029ltr.pdf
2009-05-13 00:00:00
3292 1 020764 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764
s030,s031ltr.pdf 2009-05-04 00:00:00
3293 1 020764 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764
Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf 2013-12-26 00:00:00
3294 1 020764 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s
028s033,022115s004s014,022251s002s009ltr.pdf 2015-01-07 00:00:00
3295 1 020764 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,02
0764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 2015-03-25
00:00:00
3296 1 020766 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20766se5-
018ltr.pdf 2003-12-19 00:00:00
3297 1 020766 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020766s026ltr.pdf
2009-02-18 00:00:00
3298 1 020766 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s028ltr.pdf
2010-05-25 00:00:00
3299 1 020766 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020766s029ltr.pdf
2012-01-25 00:00:00
3300 1 020766 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020766Orig1s035ltr.pdf
2015-08-11 00:00:00
3301 1 020768 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr00
4ltr.pdf 2003-06-08 00:00:00
3302 1 020768 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20768s012ltr.pdf
2004-11-19 00:00:00
3303 1 020768 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr01
3ltr.pdf 2004-01-14 00:00:00
3304 1 020768 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020768s017ltr.pdf
2010-08-16 00:00:00
3305 1 020768 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,0
21231Orig1s010,s011ltr.pdf 2012-09-18 00:00:00
3306 1 020769 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20769s003ltr.pdf
2004-08-25 00:00:00
3307 1 020769 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020769s009LTR.pdf
2006-04-24 00:00:00
3308 1 020771 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20771s4ltr.pdf
2001-04-06 00:00:00
3309 1 020771 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020771s014ltr.pdf
2006-04-05 00:00:00
3310 1 020771 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020771s022ltr.pdf
2009-04-16 00:00:00
3311 1 020771 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020771Orig1s028ltr.pdf
2012-08-03 00:00:00
3312 14 020772 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3313 14 020772 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3314 14 020772 SUPPL 5 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3315 1 020774 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20774ltr.pdf
1998-05-15 00:00:00
3316 1 020774 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020774s010ltr.pdf
2011-06-14 00:00:00
3317 1 020774 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774Orig1s012ltr.pdf
2012-11-09 00:00:00
3318 1 020776 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020776Orig1s006ltr.pdf
2016-05-12 00:00:00
3319 1 020778 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf
2002-02-05 00:00:00
3320 1 020778 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf
2002-02-05 00:00:00
3321 1 020778 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025,
020779s046, 021503s007ltr.pdf 2007-01-08 00:00:00
3322 1 020778 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s029ltr.pdf
2008-02-14 00:00:00
3323 1 020778 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779
s054,s055,021503s015,s016ltr.pdf 2010-04-28 00:00:00
3324 1 020778 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779
s054,s055,021503s015,s016ltr.pdf 2010-04-28 00:00:00
3325 1 020778 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,
021503s017ltr.pdf 2011-02-28 00:00:00
3326 1 020779 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf
2002-02-05 00:00:00
3327 1 020779 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20778slr018,20779slr03
9_Viracept_lbl.pdf 2003-07-30 00:00:00
3328 1 020779 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr04
4,21503slr003ltr.pdf 2004-06-07 00:00:00
3329 1 020779 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020779s050ltr.pdf
2008-02-14 00:00:00
3330 1 020779 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779
s054,s055,021503s015,s016ltr.pdf 2010-04-28 00:00:00
3331 1 020779 SUPPL 59 0

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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Or
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s078,020780s036l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,
019857s059,020780s038,021473s033ltr.pdf 2011-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s081,020780
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021430s000,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020785s039ltr.pdf
2010-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s048ltr.pdf
2013-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s050ltr.pdf
2013-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s055ltr.pdf
2014-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s057ltr.pdf
2015-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s058ltr.pdf
2015-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20786slr012ltr.pdf
2002-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-
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3358 1 020786 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020786s026ltr.pdf
2010-04-19 00:00:00
3359 1 020786 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010lt
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3360 1 020786 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s029ltr(r).
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s031ltr.pdf
2012-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704
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3363 1 020788 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf
2002-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf
2002-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf
2002-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s017ltr.pdf
2011-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s018ltr.pdf
2011-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s022ltr.pdf
2011-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20789slr005ltr.pdf
2002-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020789s019ltr.pdf
2006-12-04 00:00:00
3373 1 020789 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020789Orig1s021ltr.pdf
2015-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf
2009-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf
2009-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf
2010-04-21 00:00:00
3377 1 020789 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s029ltr.pdf
2011-05-31 00:00:00
3378 1 020789 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020789Orig1s034ltr.pdf
2016-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20793ltr.pdf
1999-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s3ltr.pdf
2002-01-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s4ltr.pdf
2002-02-08 00:00:00
3382 1 020796 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020796Orig1s016ltr.pdf
2014-06-17 00:00:00
3385 1 020796 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20799se2-
006ltr.pdf 2003-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20799slr012ltr.pdf
2003-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20800ltr.pdf
2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20800se5-
001ltr.pdf 2004-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20800s005ltr.pdf
2005-02-23 00:00:00
3391 1 020800 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s030ltr.pdf
2014-10-22 00:00:00
3392 1 020801 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20
902s007,20958s010ltr.pdf 2004-10-29 00:00:00
3393 1 020801 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020801s012ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20802s02ltr.pdf
1999-10-07 00:00:00
3395 1 020802 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20802slr009ltr.pdf
2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s024ltr.pdf
2014-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf 1998-
02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19700s019ltr.pdf
2002-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20812s011ltr.pdf
2004-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020812s012ltr.pdf
2006-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020812s017ltr.pdf
2011-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017533Orig1s053,020813
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022042s000,020815s025l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20816slr006ltr.pdf
2003-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_APPROV.PDF
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020818s043ltr.pdf
2010-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s060ltr.pdf
2014-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf
2014-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20819S3LTR.PDF
2000-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf
2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020819s015ltr.pdf
2005-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020819s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20822ltr.pdf
1998-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21
323s020,21365s012ltr.pdf 2005-02-23 00:00:00
3420 1 020822 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034,
021046s013, 021323s025, 021365s016ltr.pdf 2007-08-07 00:00:00
3421 1 020822 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,
ltr.pdf 2008-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046
s016,s017ltr.pdf 2011-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046O
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf
2000-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s
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3427 1 020823 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823s014,21025s007ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020823s016,
021025s008ltr.pdf 2006-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s012,20919s003ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s024,020919s014l
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020919s021ltr.pdf 2008-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919
Orig1s027,021483Orig1s007ltr.pdf 2013-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919
Orig1s032,021483Orig1s010ltr.pdf 2013-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919
Orig1s040,021483Orig1s013ltr.pdf 2014-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20827slr006ltr.pdf
2002-08-07 00:00:00
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2002-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s
019,020,020628s022,023ltr.pdf 2005-09-14 00:00:00
3443 1 020829 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s032,20830s034,21
409s011ltr.pdf 2005-01-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,
021409s012ltr.pdf 2005-07-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036,
020830s038, 021409s016ltr.pdf 2007-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,
021409s017Rev2.pdf 2005-06-29 00:00:00
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020830s040, 021409s018LTR.pdf 2006-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039,
020830s041, 021409s019ltr.pdf 2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046,
020830s048, 021409s023ltr.pdf 2008-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047,
020830s049, 021409s025ltr.pdf 2008-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,
021409s028ltr.pdf 2009-11-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,
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2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20857s015ltr.pdf
2004-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s018ltr.pdf
2006-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020857s023ltr.pdf
2009-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020857s026ltr.pdf
2010-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020857s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20859ltr.pdf
1999-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20859S1LTR.PDF
2001-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf
2002-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf
2002-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009,
s011ltr.pdf 2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009,
s011ltr.pdf 2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020859Orig1s013ltr.pdf
2013-04-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862se1-
006ltr.pdf 2004-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862s016ltr.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020862s018ltr.pdf
2005-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020862s023ltr.pdf
2008-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020862s024ltr.pdf
2009-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf
1999-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20863slr007ltr.pdf
2004-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s021ltr.pdf
2007-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf
1998-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
018,s019,020865s012,s016,s018,s020,s021ltr.pdf 2011-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020864s013ltr.pdf
2010-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF
1999-11-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020866s002ltr.pdf
2011-03-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020866Orig1s008ltr.pdf
2015-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020866Orig1s009ltr.pdf
2016-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20868slr005ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20869ltr.pdf
1998-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s022ltr.pdf
2005-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026,
s028LTR.pdf 2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s030LTR.pdf
2006-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020869Orig1s040ltr.pdf
2015-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20870slr010ltr.pdf
2004-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-
003,20625se8-010ltr.pdf 2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020872s015ltr.pdf
2005-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872s025ltr.pdf
2012-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872Orig1s029ltr.pdf
2012-08-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020872Orig1s038ltr.pdf
2016-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20873s004LTR.pdf
2002-06-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s014ltr.pdf
2005-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020873s023ltr.pdf
2010-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20874ltr.pdf
2000-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf
2000-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf
2002-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-
023,20882se8-009,21129se8-010ltr.pdf 2004-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21
129s016ltr.pdf 2005-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035,
020882s021, 021129s020LTR.pdf 2006-05-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s
056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 2013-05-07
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20883ltr.pdf
2000-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20883slr007ltr.pdf
2003-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s010ltr.pdf
2005-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020883Orig1s016ltr.pdf
2014-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20884S3ltr.pdf
2001-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20884slr007ltr.pdf
2004-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020884s012ltr.pdf
2007-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020884s014ltr.pdf
2006-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020884s018ltr.pdf
2009-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020884Orig1s030ltr.pdf
2012-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20885ltr.pdf
1998-10-09 00:00:00
3655 1 020886 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20886ltr.pdf
1999-02-02 00:00:00
3656 1 020887 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20887ltr.pdf
1998-09-14 00:00:00
3657 1 020892 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20892ltr.pdf
1998-09-25 00:00:00
3658 1 020892 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020892s013ltr.pdf
2011-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020892Orig1s016ltr.pdf
2013-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20895ltr.pdf
1998-03-27 00:00:00
3661 1 020895 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-
018,slr011,015ltr.pdf 2002-09-19 00:00:00
3662 1 020895 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020895s020ltr.pdf
2006-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s026ltr.pdf
2008-02-27 00:00:00
3664 1 020895 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020895s027ltr.pdf
2007-10-22 00:00:00
3665 1 020895 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s028,
s029ltr.pdf 2008-08-13 00:00:00
3666 1 020895 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s028,
s029ltr.pdf 2008-08-13 00:00:00
3667 1 020895 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020895s033ltr.pdf
2010-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020895s036ltr.pdf
2011-02-04 00:00:00
3669 1 020895 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020895Orig1s039,s042lt
r.pdf 2014-03-11 00:00:00
3670 1 020895 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020895Orig1s045ltr.pdf
2015-09-17 00:00:00
3671 1 020896 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20896ltr.pdf
1998-04-30 00:00:00
3672 1 020896 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda_approv.pdf
2001-04-30 00:00:00
3673 1 020896 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.htm
2001-04-30 00:00:00
3674 1 020896 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf
2001-09-07 00:00:00
3675 1 020896 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20896slr012ltr.pdf
2003-03-26 00:00:00
3676 1 020896 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020896s016ltr.pdf
2005-06-16 00:00:00
3677 1 020896 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020896s026ltr.pdf
2011-02-09 00:00:00
3678 1 020896 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020896Orig1s032ltr.pdf
2013-12-16 00:00:00
3679 1 020896 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s037ltr.pdf
2015-03-24 00:00:00
3680 1 020897 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-
033,18211se8-016,20897slr010ltr.pdf 2003-05-29 00:00:00
3681 1 020897 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020897s018ltr.pdf
2008-03-17 00:00:00
3682 1 020897 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s028ltr.pdf
2011-07-05 00:00:00
3683 1 020897 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897s030ltr.pdf
2012-03-27 00:00:00
3684 1 020897 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020897Orig1s033ltr.pdf
2015-03-02 00:00:00
3685 14 020898 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3686 14 020898 SUPPL 21 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3687 14 020898 SUPPL 38 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3688 14 020898 SUPPL 54 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3689 1 020899 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20899scm007ltr.pdf
2002-05-10 00:00:00
3690 1 020899 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020899s010ltr.pdf
2007-11-19 00:00:00
3691 1 020899 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020899s011ltr.pdf
2008-06-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20900ltr.pdf
1999-02-04 00:00:00
3693 1 020901 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20901slr002ltr.pdf
2004-05-26 00:00:00
3694 1 020902 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20
902s007,20958s010ltr.pdf 2004-10-29 00:00:00
3695 1 020902 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020902s009LTR.pdf
2006-06-12 00:00:00
3696 1 020903 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903ltr.pdf
1998-06-03 00:00:00
3697 1 020903 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf
1998-12-09 00:00:00
3698 1 020903 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf
2001-03-13 00:00:00
3699 1 020903 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf
2001-03-13 00:00:00
3700 1 020903 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pd
f 2001-07-26 00:00:00
3701 1 020903 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pd
f 2001-07-26 00:00:00
3702 1 020903 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s13ltr.pdf
2001-12-28 00:00:00
3703 1 020903 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pd
f 2001-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr023ltr.pdf
2002-09-03 00:00:00
3705 1 020903 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr028ltr.pdf
2003-06-22 00:00:00
3706 1 020903 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr030ltr.pdf
2004-06-14 00:00:00
3707 1 020903 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr034ltr.pdf
2004-06-24 00:00:00
3708 1 020903 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s039ltr.pdf
2007-04-20 00:00:00
3709 1 020903 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020905s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020905s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020905s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020905s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020908s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20911s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020911s015_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020911s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020911Orig1s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Origs026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20912slr013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20913ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20916ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20918slr003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918s012ltr.pdf
2004-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020918s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020918Orig1s040ltr.pdf
2013-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020918Orig1s042ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020918Orig1s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20825slr008,20919slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s012,20919s003ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s026,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s030,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20920ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020920s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020920s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020920s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020920s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020920Orig1s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20922ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020922s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20923ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20927ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020929s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929slr012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020929s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020929s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20931ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020931s003ltr.pdf
2011-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020931Orig1s007ltr.pdf
2013-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s009ltr.pdf
2015-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20932ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636slr016,20933slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636s17ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20636s025,20933s014ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s026,020933s015l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020636s027,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s029,020933s019l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020933s022,020636s032l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020636s035,020933s026l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s028,020636s037l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934s4ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934scm006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934scp007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020934s016LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020031s042,020936s018l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr043,20936slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20031s045,20936s020ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020937s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20939ltr.pdf
2000-01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020941s006ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020941s009ltr.pdf
2008-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf
2010-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020943s020ltr.pdf
2007-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020943Orig1s029ltr.pdf
2014-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_Approv.pdf
1998-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020944s006ltr.pdf
2008-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020944s008ltr.pdf
2009-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20659s27ltr.pdf
2002-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20659slr030,20945slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020945s016,020659s033l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s019ltr.pdf
2008-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s043,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020945s026,020659s047l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020945s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s033ltr.pdf
2012-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s034ltr.pdf
2012-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945Orig1s035ltr.pdf
2012-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s040ltr.pdf
2015-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20946ltr.pdf
1998-09-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf
2010-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020949s011LTR.pdf
2006-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020950s018ltr.pdf
2005-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020950s037ltr.pdf
2012-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20954ltr.pdf
1999-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954slr001ltr.pdf
2002-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954s003.pdf
2002-04-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf
2011-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020954Orig1s014ltr.pdf
2015-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20955s3ltr.pdf
2003-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20955s006ltr.pdf
2004-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20958ltr.pdf
2000-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20958slr007ltr.pdf
2003-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020958s012ltr.pdf
2005-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020958s013LTR.pdf
2006-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020958s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20963ltr.pdf
1998-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020963s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20965ltr.pdf
1999-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965scm004ltr.pdf
2003-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020965s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020965s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20966ltr.pdf
1999-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966slr006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20966s011ltr.pdf
2004-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20969ltr.pdf
1999-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20971s007ltr.pdf
2004-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20971s009ltr.pdf
2005-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s021ltr.pdf
2010-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972s7ltr.pdf
2002-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr016ltr.pdf
2003-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360sl
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s012ltr.pdf
2002-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973scf015ltr.pdf
2002-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20973slr016ltr.pdf
2003-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020973se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020973s025ltr.pdf
2010-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973s030ltr.pdf
2012-05-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020973Orig1s032ltr.pdf
2013-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074,
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
937S003_OptiMark_Approv.pdf 2004-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020975s010ltr.pdf
2008-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011,
020976s011, 020975s012ltr.pdf 2007-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,
020976s016ltr.pdf 2010-12-22 00:00:00
3898 1 020975 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020975s022ltr.pdf02093
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3899 1 020975 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s021,020975
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf
1998-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-
011,20978se7-013ltr.pdf 2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,
020978s013,020978s014ltr.pdf 2009-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028l
tr.pdf 2012-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029l
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3910 1 020977 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978
Orig1s031ltr.pdf 2015-03-25 00:00:00
3911 1 020977 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978
Orig1s032ltr.pdf 2015-02-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978
Orig1s034ltr.pdf 2015-10-02 00:00:00
3913 1 020978 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr01
0ltr.pdf 2002-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-
011,20978se7-013ltr.pdf 2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,
020978s013,020978s014ltr.pdf 2009-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr
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3917 1 020978 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014,
020978s016LTR.pdf 2006-08-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016,
020978s019ltr.pdf 2007-05-09 00:00:00
3919 1 020978 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019,
020978s022ltr.pdf 2008-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,
021205s024,021652s011ltr.pdf 2010-08-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,
021205s028,021652s013ltr.pdf 2011-05-17 00:00:00
3923 1 020978 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028l
tr.pdf 2012-03-19 00:00:00
3924 1 020978 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029l
tr.pdf 2012-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978
Orig1s031ltr.pdf 2015-03-25 00:00:00
3926 1 020978 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978
Orig1s032ltr.pdf 2015-02-24 00:00:00
3927 1 020978 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978
Orig1s034ltr.pdf 2015-10-02 00:00:00
3928 1 020980 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020980s009ltr.pdf
2012-03-26 00:00:00
3929 1 020981 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020981s002ltr.pdf
2010-07-02 00:00:00
3930 1 020981 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020981s005ltr.pdf
2011-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20983ltr.pdf
2001-04-19 00:00:00
3932 1 020983 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020983s009ltr.pdf
2005-04-28 00:00:00
3933 1 020983 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020983Orig1s027ltr.pdf
2012-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020983Orig1s032ltr.pdf
2014-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20984ltr.pdf
1999-08-18 00:00:00
3936 1 020986 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20986ltr.pdf
2020-03-23 00:00:00
3937 14 020986 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3938 14 020986 SUPPL 3 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3939 14 020986 SUPPL 11 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3940 14 020986 SUPPL 19 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3941 14 020986 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3942 14 020986 SUPPL 24 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3943 14 020986 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3944 14 020986 SUPPL 45 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3945 14 020986 SUPPL 47 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3946 14 020986 SUPPL 50 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3947 14 020986 SUPPL 54 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3948 14 020986 SUPPL 55 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3949 14 020986 SUPPL 57 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3950 14 020986 SUPPL 58 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3951 14 020986 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3952 14 020986 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3953 14 020986 SUPPL 80 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3954 14 020986 SUPPL 81 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3955 14 020986 SUPPL 82 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
3956 1 020987 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20987ltr.pdf
2000-02-02 00:00:00
3957 1 020987 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf
2001-06-12 00:00:00
3958 1 020987 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987s007.pdf
2002-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20998s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s010,s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021001Orig1s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s005,21004s006ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s006,21004s007ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021003s013,021004s013l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021003Orig1s015.021004
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21004s2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021003s010,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021005Orig1s016ltr.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021006Orig1s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021007s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21014se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21014s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21014s012,21285s007ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s
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00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s
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00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s
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00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021014Orig1s029,021285
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s033,021285
Orig1s027ltr.pdf 2014-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s035,021285
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21015slr004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21015s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021015s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021016s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21017ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017slr010ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017scm013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017scm018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s941878188197176
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s072ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s082ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021024s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021024s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s011ltr.pdf
2014-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021024Orig1s013ltr.pdf
2015-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf
2000-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823s014,21025s007ltr
.pdf 2004-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s
028,s029,021025Orig1s018,s019,s0020ltr.pdf 2013-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020823Orig1s032,021025
Orig1s022ltr.pdf 2015-02-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s032,21505s002ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s033,21505s003ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021036s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s049,021037s023l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021038s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021038Orig1s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21040LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021041Orig1s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21042ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021045s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021045s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021042Orig1s033,021052
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021065Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s016LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,
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2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028,
021842S002ltr.pdf 2006-11-07 00:00:00
4212 1 021073 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s031LTR.pdf
2007-08-17 00:00:00
4213 1 021073 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s033ltr.pdf
2008-05-09 00:00:00
4214 1 021073 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021073s037ltr.pdf
2009-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021073s040ltr.pdf
2010-07-30 00:00:00
4216 1 021073 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-
021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 2011-08-05
00:00:00
4217 1 021073 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021073Orig1s046ltr.pdf
2013-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21074ltr.pdf
2001-10-02 00:00:00
4219 1 021074 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s007ltr.pdf
2012-05-21 00:00:00
4220 1 021074 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s008ltr.pdf
2012-06-11 00:00:00
4221 1 021074 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021074Orig1s009ltr.pdf
2013-02-20 00:00:00
4224 1 021076 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21076ltr.pdf
1999-11-29 00:00:00
4225 1 021076 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21076slr007LTR.pdf
2002-07-31 00:00:00
4226 1 021077 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21077slr008ltr.pdf
2002-08-21 00:00:00
4227 1 021077 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s026LTR.pdf
2006-10-02 00:00:00
4228 1 021077 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021077s036ltr.pdf
2009-04-03 00:00:00
4229 1 021077 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s041ltr.pdf
2011-01-07 00:00:00
4230 1 021077 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,
020692s036ltr.pdf 2010-06-29 00:00:00
4231 1 021077 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,
020692s039ltr.pdf 2011-07-05 00:00:00
4232 1 021077 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s053ltr.pdf
2014-11-14 00:00:00
4233 1 021077 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021077Orig1s054ltr.pdf
2016-05-02 00:00:00
4234 1 021078 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
078_Malarone_Approv.pdf 2003-06-16 00:00:00
4235 1 021078 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf
2005-03-03 00:00:00
4236 1 021078 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021078s012ltr.pdf
2008-01-09 00:00:00
4237 1 021078 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s016ltr.pdf
2008-12-29 00:00:00
4238 1 021078 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021078Orig1s022ltr.pdf
2013-03-01 00:00:00
4239 1 021079 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21079ltr.pdf
1999-09-24 00:00:00
4240 14 021081 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4241 14 021081 SUPPL 24 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4242 1 021082 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21082ltr.pdf
2001-03-01 00:00:00
4243 1 021083 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083se1-
006,21110se1-004ltr.pdf 2003-04-18 00:00:00
4244 1 021083 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,211
10slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00
4245 1 021083 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21110slr013,21083slr01
4ltr.pdf 2004-06-14 00:00:00
4246 1 021083 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s
027,028ltr.pdf 2005-07-08 00:00:00
4247 1 021083 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s
030,031ltr.pdf 2005-10-14 00:00:00
4248 1 021083 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024,
s025, 021110s032, s034LTR.pdf 2006-06-06 00:00:00
4249 1 021083 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s026,
021110s035_ltr.pdf 2007-01-16 00:00:00
4250 1 021083 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s029,
021110s037ltr.pdf 2007-02-12 00:00:00
4251 1 021083 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s030,
021101s038ltr.pdf 2007-01-25 00:00:00
4252 1 021083 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s031,021110s039l
tr.pdf 2007-05-09 00:00:00
4253 1 021083 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s034,021110s045l
tr.pdf 2007-10-22 00:00:00
4254 1 021083 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036,
s037, 021110s047, s048ltr.pdf 2008-03-07 00:00:00
4255 1 021083 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021110s051,021083s041l
tr.pdf 2009-11-10 00:00:00
4256 1 021083 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s
044,s047ltr.pdf 2010-12-07 00:00:00
4257 1 021083 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s046,021110s056l
tr.pdf 2010-07-08 00:00:00
4258 1 021083 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s
044,s047ltr.pdf 2010-12-07 00:00:00
4259 1 021083 SUPPL 49 0

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tr.pdf 2011-07-13 00:00:00
4260 1 021083 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s050,021110s060l
tr.pdf 2011-06-09 00:00:00
4261 1 021083 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021083Orig1s053,021110
Orig1s067ltr.pdf 2013-03-08 00:00:00
4262 1 021083 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021110Orig1s068,021083
Orig1s054ltr.pdf 2013-09-17 00:00:00
4263 1 021083 SUPPL 55 0

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Orig1s073ltr.pdf 2015-05-29 00:00:00
4264 1 021083 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s056,021110
Orig1s074ltr.pdf 2015-03-10 00:00:00
4265 1 021083 SUPPL 58 0

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Orig1075ltr.pdf 2015-11-09 00:00:00
4266 1 021085 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf
2002-06-12 00:00:00
4267 1 021085 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-
015slr017,21277slr006se1-007slr009ltr.pdf 2003-03-10 00:00:00
4268 1 021085 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21085se1-
022,21277se1-017ltr.pdf 2004-05-26 00:00:00
4269 1 021085 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277slr018,21085slr02
3ltr.pdf 2004-03-10 00:00:00
4270 1 021085 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277s019,21085s024ltr
.pdf 2004-07-30 00:00:00
4271 1 021085 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s026,021277s022l
tr.pdf 2005-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s
024,025ltr.pdf 2005-11-30 00:00:00
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024,025ltr.pdf 2005-11-30 00:00:00
4274 1 021085 SUPPL 36 0

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tr.pdf 2007-06-04 00:00:00
4275 1 021085 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s038ltr.pdf
2008-02-20 00:00:00
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021277s034ltr.pdf 2008-10-07 00:00:00
4277 1 021085 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s041,021277s035l
tr.pdf 2009-06-29 00:00:00
4278 1 021085 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s044,021277s038l
tr.pdf 2010-11-02 00:00:00
4279 1 021085 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s046,021277s040l
tr.pdf 2010-04-09 00:00:00
4280 1 021085 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s047,021277s041l
tr.pdf 2011-03-02 00:00:00
4281 1 021085 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277
s046,s050ltr.pdf 2011-10-20 00:00:00
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Orig1s052ltr.pdf 2012-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21086ltr.pdf
2000-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029,
021086s011, 021253s006ltr.pdf 2006-09-18 00:00:00
4285 1 021086 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,
020592s035ltr.pdf 2006-03-01 00:00:00
4286 1 021086 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s
022s023_021253s026_ltr.pdf 2007-07-10 00:00:00
4287 1 021086 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,
021253s036ltr.pdf 2009-11-19 00:00:00
4288 1 021086 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,
021253s037ltr.pdf 2010-02-01 00:00:00
4289 1 021086 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086
s034,s032,021253s043,s039ltr.pdf 2010-06-03 00:00:00
4290 1 021086 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086
s034,s032,021253s043,s039ltr.pdf 2010-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,
021253s045ltr.pdf 2010-12-06 00:00:00
4292 1 021086 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086
s038,s039ltr.pdf 2011-06-27 00:00:00
4293 1 021086 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,0
18936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 2013-
07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21087s2.ltr.pdf
2000-11-17 00:00:00
4295 1 021087 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s013ltr.pdf
2009-11-05 00:00:00
4296 1 021087 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008l
tr.pdf 2009-10-16 00:00:00
4297 1 021087 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013l
tr.pdf 2009-10-19 00:00:00
4298 1 021087 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s023ltr.pdf
2005-04-28 00:00:00
4299 1 021087 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s025ltr.pdf
2005-11-01 00:00:00
4300 1 021087 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s026ltr.pdf
2005-08-19 00:00:00
4301 1 021087 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s027ltr.pdf
2009-10-19 00:00:00
4302 1 021087 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019l
tr.pdf 2009-10-19 00:00:00
4303 1 021087 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030r
ev2.pdf 2006-01-18 00:00:00
4304 1 021087 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020l
tr.pdf 2009-10-19 00:00:00
4305 1 021087 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s044ltr.pdf
2007-12-18 00:00:00
4307 1 021087 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s046ltr.pdf
2009-10-19 00:00:00
4308 1 021087 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s
034s035ltr.pdf 2010-02-26 00:00:00
4309 1 021087 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039l
tr.pdf 2011-03-24 00:00:00
4310 1 021087 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246
Orig1s043ltr.pdf 2014-11-28 00:00:00
4311 1 021087 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246
Orig1s044ltr.pdf 2013-01-29 00:00:00
4312 1 021087 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246
Orig1s045ltr.pdf 2012-12-21 00:00:00
4313 1 021087 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246
Orig1s047ltr.pdf 2014-06-03 00:00:00
4314 1 021090 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021090s004LTR.pdf
2007-03-31 00:00:00
4315 1 021092 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21092ltr.pdf
1999-12-17 00:00:00
4316 1 021093 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21093s004ltr.pdf
2004-12-30 00:00:00
4317 1 021093 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012l
tr.pdf 2011-03-16 00:00:00
4318 1 021093 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021093s013ltr.pdf
2011-06-17 00:00:00
4319 1 021093 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021093s015ltr.pdf
2012-04-02 00:00:00
4320 1 021093 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021093Orig1s016ltr.pdf
2015-02-10 00:00:00
4321 1 021093 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021093Orig1s018ltr.pdf
2013-04-30 00:00:00
4322 1 021093 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021093Orig1s019ltr.pdf
2016-02-11 00:00:00
4323 1 021097 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21097ltr.pdf
2000-09-21 00:00:00
4324 1 021097 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21097s007,009ltr.pdf
2005-02-11 00:00:00
4325 1 021097 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003l
tr.pdf 2009-03-27 00:00:00
4326 1 021097 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021097Orig1s016ltr.pdf
2013-03-08 00:00:00
4327 1 021098 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
098_Yasmin_Approv.pdf 2001-05-11 00:00:00
4328 1 021098 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21098se8-
005ltr.pdf 2003-05-30 00:00:00
4329 1 021098 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021098s017ltr.pdf
2010-04-09 00:00:00
4330 1 021098 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s019ltr.pdf
2012-02-17 00:00:00
4331 1 021098 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532
Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf 2015-06-03 00:00:00
4332 1 021103 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21103ltr.pdf
2000-04-11 00:00:00
4333 14 021106 SUPPL 36 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4334 1 021107 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21107s5ltr.pdf
2002-06-07 00:00:00
4335 1 021107 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107scf008ltr.pdf
2003-12-24 00:00:00
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2011-06-29 00:00:00
4458 1 021144 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s019ltr.pdf
2015-11-09 00:00:00
4459 1 021146 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021146Orig1s015ltr.pdf
2015-11-04 00:00:00
4460 14 021148 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4461 14 021148 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4462 14 021148 SUPPL 4 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4463 14 021148 SUPPL 6 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4464 14 021148 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4465 14 021148 SUPPL 15 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4466 14 021148 SUPPL 16 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4467 14 021148 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4468 14 021148 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4469 14 021148 SUPPL 42 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4470 14 021148 SUPPL 43 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4471 1 021149 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21149ltr.pdf
2020-03-23 00:00:00
4472 1 021149 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021149s020ltr.pdf
2020-03-23 00:00:00
4473 1 021150 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21150se8-
002ltr.pdf 2003-05-29 00:00:00
4474 1 021150 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr00
5,30346slr011ltr.pdf 2004-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21151ltr.pdf
2000-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs005ltr.pdf
2003-04-18 00:00:00
4477 1 021151 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s009ltr.pdf
2011-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021152s002ltr.pdf
2010-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021152Orig1s004ltr.pdf
2015-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021152s005ltr.pdf
2011-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21153slr005ltr.pdf
2002-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr008ltr.pdf
2004-01-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021153s020ltr.pdf
2005-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s023LTR.pdf
2006-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s024ltr.pdf
2006-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021153s027,
021689s008ltr.pdf 2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s033,022101s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,
021957s007,022101s004ltr.pdf 2010-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,
022101s006ltr.pdf 2010-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957
Orig1s012,022101Orig1s009ltr.pdf 2012-10-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957
Orig1s013,022101Orig1s010ltr.pdf 2012-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21156ltr.pdf
1999-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21156scf001scp002ltr.p
df 2002-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020998s033,021156s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s002ltr.pdf
2004-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021158s012ltr.pdf
2008-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021158s014ltr.pdf
2009-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021158Orig1s022ltr.pdf
2013-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021158Orig1s023ltr.pdf
2016-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21159scp001ltr.pdf
2004-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021159Orig1s019ltr.pdf
2012-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021159Orig1s020ltr.pdf
2013-05-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21160ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021160s015ltr.pdf
2011-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021162s016ltr.pdf
2007-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf
2009-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s030ltr.pdf
2012-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s034ltr.pdf
2012-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162Orig1s035ltr.pdf
2012-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21163s011ltr.pdf
2004-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21312slr004,21165slr00
6ltr.pdf 2004-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s
3s4s5,021312s6s8s9ltr.pdf 2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s
3s4s5,021312s6s8s9ltr.pdf 2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,
021312s011,021563s001ltr.pdf 2010-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300
Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf 2014-04-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21166ltr.pdf
2004-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021166s005_ltr.pdf
2007-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21168ltr.pdf
2000-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20782,21168slr004ltr.p
df 2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21168se5-
007ltr.pdf 2004-06-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021168s012ltr.pdf
2005-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s
15,18723s33,19680s22,21168s14.pdf 2006-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s
022ltr.pdf 2011-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021168s018ltr.pdf
2009-05-04 00:00:00
4527 1 021168 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s
022ltr.pdf 2011-10-19 00:00:00
4529 1 021168 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s
022ltr.pdf 2011-10-19 00:00:00
4530 1 021168 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,
018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf2013-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021168Orig1s030ltr.pdf
2015-04-16 00:00:00
4533 1 021168 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082
Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf
2015-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21169ltr.pdf
2001-02-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21224slr005,21169slr00
7ltr.pdf 2003-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,212
24s8s10s11s12,21615s1s3s4s5LTR.pdf 2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,212
24s8s10s11s12,21615s1s3s4s5LTR.pdf 2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,
021615s009ltr.pdf 2012-03-05 00:00:00
4540 1 021169 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224
Orig1s022,021615Orig1s016ltr.pdf 2013-07-02 00:00:00
4541 1 021169 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224
Orig1s029,021615Orig1s022ltr.pdf 2015-12-17 00:00:00
4542 1 021172 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_Approv.pdf
2020-03-23 00:00:00
4543 14 021172 SUPPL 3 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4544 14 021172 SUPPL 21 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4545 14 021172 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4546 14 021172 SUPPL 51 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4547 14 021172 SUPPL 53 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
4552 1 021176 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
141_Welchol_Approv.pdf 2004-06-30 00:00:00
4553 1 021176 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21176scp005ltr.pdf
2002-10-17 00:00:00
4554 1 021176 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr009ltr.pdf
2003-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs010ltr.pdf
2003-11-25 00:00:00
4556 1 021176 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s014_ltr.pdf
2006-09-18 00:00:00
4557 1 021176 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s017ltr.pdf
2008-01-23 00:00:00
4558 1 021176 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s021ltr.pdf
2008-06-06 00:00:00
4559 1 021176 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000l
tr.pdf 2009-10-26 00:00:00
4560 1 021176 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002l
tr.pdf 2010-09-16 00:00:00
4561 1 021176 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009l
tr.pdf 2012-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362
Orig1s010ltr.pdf 2012-07-13 00:00:00
4563 1 021176 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362
Orig1s020ltr.pdf 2014-01-23 00:00:00
4564 1 021176 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,0
22362Orig1s015,s017,s018ltr_replace.pdf 2013-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21178ltr.pdf
2000-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021178s010ltr.pdf
2008-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021178s012ltr.pdf
2010-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021178Orig1s015ltr.pdf
2013-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s021LTR.pdf
2007-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,
022318s003ltr.pdf 2011-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021179Orig1s030ltr.pdf
2014-11-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021179Orig1s032ltr.pdf
2016-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180slr008ltr.pdf
2004-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180s014ltr.pdf
2004-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s015ltr.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s019ltr.pdf
2005-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s029ltr.pdf
2009-11-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028,
s030, s031ltr.pdf 2008-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s033ltr.pdf
2009-11-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s034ltr.pdf
2010-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021180s035ltr.pdf
2010-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021180Orig1s044ltr.pdf
2013-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021180Orig1s047ltr.pdf
2015-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
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r.pdf 2016-05-11 00:00:00
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101s031,18936s069ltr.pdf 2004-08-25 00:00:00
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Orig1s018ltr.pdf 2011-06-23 00:00:00
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r.pdf 2011-05-10 00:00:00
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4792 1 021254 ORIG 1 0

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2006-06-14 00:00:00
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630s004ltr.pdf 2005-03-29 00:00:00
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00:00:00
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021630s022ltr.pdf 2010-12-21 00:00:00
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021630s023ltr.pdf 2010-11-30 00:00:00
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022437s002ltr.pdf 2011-01-20 00:00:00
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2012-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518Orig1s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021518Orig1s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s025,028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s031,s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527s005_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21528ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021528s005ltr.pdf
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2007-11-19 00:00:00
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2011-05-05 00:00:00
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2011-05-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s021ltr_r.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021532Orig1s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s025ltr.pdf
2014-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021540Orig1s030,s031lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21543ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s051,021546
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21548ltr.pdf
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2006-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021812Orig1s009ltr.pdf
2014-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021813s000ltr.pdf
2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021813s001ltr.pdf
2008-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021813s003ltr.pdf
2012-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s004ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021814Orig1s015,022292
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021817s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021817s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021817s003ltr.pdf
2009-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s009ltr.pdf
2011-01-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s013ltr.pdf
2011-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021817Orig1s015ltr.pdf
2013-04-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021817Orig1s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021818ltr.pdf
2005-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021821ltr.pdf
2005-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s006ltr.pdf
2007-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s007ltr.pdf
2007-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s022ltr.pdf
2009-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,
021821s027ltr.pdf 2010-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s042ltr.pdf
2016-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s043ltr.pdf
2016-01-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021823ltr.pdf
2005-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s003LTR.pdf
2006-06-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s004_LTR.pdf
2006-09-18 00:00:00
6268 1 021823 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf
2011-01-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf
2011-01-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s008ltr.pdf
2011-08-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s010ltr.pdf
2015-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021825s001ltr.pdf
2012-04-24 00:00:00
6273 1 021825 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021825Orig1s003ltr.pdf
2015-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf
2012-04-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021830Orig1s010ltr.pdf
2016-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021832ltr.pdf
2005-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf
2011-01-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021839ltr.pdf
2020-03-23 00:00:00
6279 14 021839 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
6280 1 021840 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021840s000LTR.pdf
2006-05-26 00:00:00
6281 1 021842 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010l
tr.pdf 2012-05-18 00:00:00
6283 1 021842 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s011ltr.pdf
2009-11-25 00:00:00
6284 1 021842 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-
021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 2011-08-04
00:00:00
6285 1 021842 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021842Orig1s019ltr.pdf
2014-08-19 00:00:00
6286 1 021844 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021844s002ltr.pdf
2010-01-05 00:00:00
6287 1 021844 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021844Orig1s008ltr.pdf
2014-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845ltr.pdf
2005-06-07 00:00:00
6289 1 021845 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s003_ltr.pdf
2006-07-21 00:00:00
6290 1 021845 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021845s004ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s006ltr.pdf
2009-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021845Orig1s008ltr.pdf
2012-09-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;02
2473Orig1s005,006;203109Orig1s003,004ltr.pdf 2014-02-04 00:00:00
6295 1 021845 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473
Orig1s010,203109Origs009ltr.pdf 2015-04-29 00:00:00
6296 14 021846 SUPPL 98 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
6297 14 021846 SUPPL 99 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021849s000ltr.pdf
2006-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,
021850s003,022456s002ltr.pdf 2010-09-08 00:00:00
6301 1 021849 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849
Orig1s007ltr.pdf 2012-11-14 00:00:00
6302 1 021849 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849
Orig1s010ltr.pdf 2014-12-24 00:00:00
6303 1 021850 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021850s000ltr.pdf
2006-04-05 00:00:00
6304 1 021850 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,
021850s002ltr.pdf 2010-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021852s006ltr.pdf
2010-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s015ltr.pdf
2014-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s016ltr.pdf
2014-07-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021855ltr.pdf
2005-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021856s003ltr.pdf
2011-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s000ltr.pdf
2006-01-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s001LTR.pdf
2006-08-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021858s004ltr.pdf
2007-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s019ltr.pdf
2015-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s020ltr.pdf
2015-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021859ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021859s006ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s009ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s015ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021859Orig1s023ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021860s000LTR.pdf
2006-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021860Orig1s010ltr.pdf
2014-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021861s000ltr.pdf
2008-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021861s009ltr.pdf
2012-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021861Orig1s011ltr.pdf
2015-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021862ltr.pdf
2005-08-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021862s008ltr.pdf
2011-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021864s000ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021864s002ltr.pdf
2008-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021864Orig1s007ltr.pdf
2016-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021866s000ltr.pdf
2006-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-
006,021866se1-007,021866s009ltr.pdf 2008-05-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713
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00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021870ltr.pdf
2005-08-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021870s004ltr.pdf
2010-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021871s000ltr.pdf
2006-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021872s005ltr.pdf
2008-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021872Orig1s016ltr.pdf
2014-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021873s000LTR.pdf
2006-10-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf
2013-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf
2015-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021876Orig1s000ltr.pdf
2013-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021879Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021880s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021897Orig1s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021902Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021902Orig1s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021903s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021903s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022116s000ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s020,022116s004l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s021_022116s005l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021548s024,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s029,022116s013l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021548Orig1s035,022116
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022117s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022118s001ltr.pdf
2008-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022119s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022124s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022128s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022128s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022128s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022128s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022128s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022128Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022128Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022134Orig1s004ltr.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022142Orig1s000ltr.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15others
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s018ltr.pdf
2011-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022152Orig1s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022154s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022011s003,022154s001l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022155s000ltr_CKD.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022155Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022155Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022157s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022064s017,022157s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022064s020,022157s007l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022064Orig1s028,022157
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022159s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022160s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022160Orig1s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022160Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s003ltr.pdf
2009-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022165s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022165Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022172s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173Orig1s008,s010,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022173Orig1s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021837s000,022177s000l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022181s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022187Orig1s016ltr.pdf
2014-08-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022192s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022192Orig1s007ltr.pdf
2013-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022192s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022193s000ltr.pdf
2008-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022195s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022195s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022195s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022195Orig1s009ltr.pdf
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2011-09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022200Orig1s000_correc
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022201s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003,s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022202Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022203Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022204s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022204Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022205Orig1s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022206Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022206Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022207s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022210s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022234s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022246s000ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022247Orig1s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s002,022303s000l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022253s004,022254s001l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022255s009ltr.pdf02225
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021304s008,022257s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022272s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022276s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022276s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022281s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022283Orig1s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022285s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022287Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s008,022292s002l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022294s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022295s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022299s000TAltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022301s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022306s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022307s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022308s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022309s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022311s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022311Orig1s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022311Orig1s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022312s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022314Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022315s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022320s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022321Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022325s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022342s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022344s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022348Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022350s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022350Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022396Orig1s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022410s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020659s056,022417s007l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s013ltr.pdf
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2011-12-13 00:00:00
7408 14 022458 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7409 14 022458 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7410 14 022458 SUPPL 3 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7411 14 022458 SUPPL 6 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7412 14 022458 SUPPL 12 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7413 1 022460 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000ltr.pdf
2010-06-16 00:00:00
7414 1 022460 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022460s001ltr.pdf
2011-06-13 00:00:00
7415 1 022460 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022460s002ltr.pdf
2012-06-29 00:00:00
7416 1 022460 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s
005ltr.pdf 2013-04-30 00:00:00
7417 1 022461 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022461s000ltr.pdf
2010-01-05 00:00:00
7418 1 022462 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022462Orig1s008ltr.pdf
2015-02-12 00:00:00
7419 1 022465 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022465s000ltr.pdf
2009-11-03 00:00:00
7420 1 022465 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022465s002ltr.pdf
2010-05-03 00:00:00
7421 1 022465 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf
2011-10-25 00:00:00
7422 1 022465 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf
2011-10-25 00:00:00
7423 1 022465 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s006ltr.pdf
2011-04-22 00:00:00
7424 1 022465 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s007ltr.pdf
2012-01-17 00:00:00
7425 1 022465 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf
2012-05-02 00:00:00
7426 1 022465 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s011ltr.pdf
2012-03-26 00:00:00
7427 1 022465 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465Orig1s013ltr.pdf
2012-11-16 00:00:00
7428 1 022465 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s
016ltr.pdf 2013-08-16 00:00:00
7429 1 022465 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s017ltr.pdf
2013-12-18 00:00:00
7430 1 022465 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s019ltr.pdf
2014-11-20 00:00:00
7431 1 022465 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s020ltr.pdf
2015-04-02 00:00:00
7432 1 022466 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022466s000ltr.pdf
2010-03-04 00:00:00
7433 1 022466 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022466s001ltr.pdf
2011-01-25 00:00:00
7434 1 022468 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022468s001ltr.pdf
2010-04-29 00:00:00
7435 1 022468 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005lt
r.pdf 2011-01-14 00:00:00
7436 1 022468 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005lt
r.pdf 2011-01-14 00:00:00
7437 1 022468 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf
2012-06-04 00:00:00
7438 14 022472 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7439 14 022472 SUPPL 5 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7440 14 022472 SUPPL 6 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7441 1 022473 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022473s000ltr.pdf
2009-11-20 00:00:00
7442 1 022473 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022473Orig1s003ltr.pdf
2012-09-05 00:00:00
7443 1 022473 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473
Orig1s004,203109Origs002ltr.pdf 2014-03-13 00:00:00
7444 1 022473 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;02
2473Orig1s005,006;203109Orig1s003,004ltr.pdf 2014-02-04 00:00:00
7445 1 022473 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;02
2473Orig1s005,006;203109Orig1s003,004ltr.pdf 2014-02-04 00:00:00
7446 1 022473 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473
Orig1s007,203109Orig1s005ltr.pdf 2014-03-07 00:00:00
7447 1 022474 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022474s000ltr.pdf
2010-08-13 00:00:00
7448 1 022474 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022474s002ltr.pdf
2012-05-04 00:00:00
7449 1 022474 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s004ltr.pdf
2014-06-17 00:00:00
7450 1 022474 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022474Orig1s007ltr.pdf
2015-03-11 00:00:00
7451 1 022483 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022483s000ltr.pdf
2010-03-29 00:00:00
7452 1 022483 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001l
tr.pdf 2011-03-25 00:00:00
7453 1 022483 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s002ltr.pdf
2011-10-03 00:00:00
7454 1 022483 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s003ltr.pdf
2011-07-19 00:00:00
7455 1 022484 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022484s000ltr.pdf
2010-05-05 00:00:00
7456 1 022485 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000(1)ltr.pdf
2011-05-12 00:00:00
7457 1 022488 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488
s001,s002,s003ltr.pdf 2011-04-29 00:00:00
7458 1 022488 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022488s006ltr.pdf
2012-04-18 00:00:00
7459 1 022488 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s007ltr.pdf
2013-03-01 00:00:00
7460 1 022496 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022496s000ltr.pdf
2011-10-31 00:00:00
7461 1 022496 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022496Orig1s005ltr.pdf
2014-12-09 00:00:00
7462 1 022496 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022496Orig1s019ltr.pdf
2015-12-14 00:00:00
7463 1 022500 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022499s000,022500s000l
tr.pdf 2009-12-11 00:00:00
7464 1 022502 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022502s000ltr.pdf
2010-03-22 00:00:00
7465 1 022504 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022504Orig1s011ltr.pdf
2014-06-23 00:00:00
7466 14 022505 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7467 1 022510 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s003ltr.pdf
2012-01-03 00:00:00
7468 1 022510 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s007ltr.pdf
2013-11-12 00:00:00
7469 1 022510 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s010ltr.pdf
2013-07-30 00:00:00
7470 1 022510 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s013ltr.pdf
2014-12-24 00:00:00
7471 1 022510 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s014ltr.pdf
2014-12-30 00:00:00
7472 1 022511 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022511s000ltr.pdf
2010-05-07 00:00:00
7473 1 022511 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf
2011-06-29 00:00:00
7474 1 022511 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511s006ltr.pdf
2012-01-23 00:00:00
7475 1 022511 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s010ltr.pdf
2014-03-28 00:00:00
7476 1 022511 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s016ltr.pdf
2015-06-23 00:00:00
7477 1 022511 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s018ltr.pdf
2016-05-10 00:00:00
7478 1 022512 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s005ltr.pdf
2011-04-07 00:00:00
7479 1 022512 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s007ltr.pdf
2011-11-14 00:00:00
7480 1 022512 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s014ltr.pdf
2012-11-06 00:00:00
7481 1 022512 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s021ltr.pdf
2013-12-13 00:00:00
7482 1 022512 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s023ltr.pdf
2014-08-15 00:00:00
7483 1 022512 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s024ltr.pdf
2015-01-20 00:00:00
7484 1 022512 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s025ltr.pdf
2014-09-08 00:00:00
7485 1 022512 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s027ltr.pdf
2015-09-14 00:00:00
7486 1 022512 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s028ltr.pdf
2015-11-23 00:00:00
7487 1 022512 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s032ltr.pdf
2015-10-26 00:00:00
7488 1 022514 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022514s000ltr.pdf
2010-03-24 00:00:00
7489 1 022518 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022518s000ltr.pdf
2010-06-29 00:00:00
7490 1 022518 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf
2011-08-22 00:00:00
7491 1 022518 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s006ltr.pdf
2012-11-26 00:00:00
7492 1 022518 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s008ltr.pdf
2013-01-17 00:00:00
7493 1 022518 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s011ltr.pdf
2013-08-01 00:00:00
7494 1 022518 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022518Orig1s018ltr.pdf
2015-12-29 00:00:00
7495 1 022519 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022519Orig1s009ltr.pdf
2016-05-10 00:00:00
7496 1 022522 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022522s000ltr.pdf
2011-03-07 00:00:00
7497 14 022523 SUPPL 4 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7498 1 022524 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022524Orig1s003ltr.pdf
2014-09-23 00:00:00
7499 1 022525 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s006ltr.pdf
2014-10-01 00:00:00
7501 1 022527 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022527s000ltr.pdf
2010-09-27 00:00:00
7502 1 022527 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022527s002ltr.pdf
2011-07-25 00:00:00
7503 1 022527 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s005ltr.pdf
2012-03-05 00:00:00
7504 1 022527 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s008ltr.pdf
2012-05-11 00:00:00
7505 1 022527 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s013ltr.pdf
2015-05-04 00:00:00
7506 1 022527 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s015ltr.pdf
2015-05-19 00:00:00
7507 1 022527 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s016ltr.pdf
2015-07-10 00:00:00
7508 1 022527 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s018ltr.pdf
2016-02-23 00:00:00
7509 1 022532 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022532s000ltr.pdf
2010-09-29 00:00:00
7510 1 022532 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022532s001ltr.pdf
2012-02-21 00:00:00
7511 1 022534 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022534s000TAltr.pdf
2010-03-22 00:00:00
7512 1 022534 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022534Orig1s002ltr.pdf
2012-07-20 00:00:00
7513 1 022535 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022535Orig1s000ltr.pdf
2014-10-22 00:00:00
7514 1 022537 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022537s000ltr.pdf
2010-09-01 00:00:00
7515 14 022542 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
7516 1 022544 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s000ltr.pdf
2011-02-03 00:00:00
7517 1 022544 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s002ltr.pdf
2011-07-05 00:00:00
7518 1 022544 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544Orig1s008ltr.pdf
2012-08-10 00:00:00
7519 1 022545 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022545s000ltr.pdf
2010-08-31 00:00:00
7520 1 022545 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013lt
r.pdf 2012-10-02 00:00:00
7521 1 022545 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s012ltr.pdf
2012-04-18 00:00:00
7522 1 022545 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013lt
r.pdf 2012-10-02 00:00:00
7523 1 022545 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022545Orig1s014ltr.pdf
2013-11-06 00:00:00
7524 1 022545 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s017ltr.pdf
2015-12-23 00:00:00
7525 1 022548 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022548s000ltr.pdf
2010-05-21 00:00:00
7526 1 022549 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022549Orig1s002ltr.pdf
2013-12-13 00:00:00
7527 1 022554 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022554s000ltr.pdf
2010-03-29 00:00:00
7528 1 022556 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022556Orig1s000ltr.pdf
2013-04-01 00:00:00
7529 1 022560 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022560s000ltr.pdf
2010-10-19 00:00:00
7530 1 022560 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf
2011-02-15 00:00:00
7531 1 022560 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022560Orig1s005ltr.pdf
2013-04-24 00:00:00
7532 1 022560 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s007ltr.pdf
2015-04-13 00:00:00
7533 1 022563 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022563s000ltr.pdf
2010-10-13 00:00:00
7534 1 022563 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022563s001ltr.pdf
2011-04-25 00:00:00
7535 1 022567 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s000ltr.pdf
2011-01-26 00:00:00
7536 1 022567 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s001ltr.pdf
2011-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s002ltr.pdf
2011-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022567Orig1s009ltr.pdf
2013-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022567Orig1s012ltr.pdf
2015-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s013ltr.pdf
2014-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s000ltr.pdf
2010-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s000ltr.pdf
2011-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s002ltr.pdf
2011-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s005ltr.pdf
2012-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022569s007ltr.pdf
2012-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022571Orig1s003ltr.pdf
2013-05-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022571Orig1s004ltr.pdf
2015-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022571Orig1s006ltr.pdf
2016-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022572Orig1s003ltr.pdf
2014-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022574s000ltr.pdf
2010-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022574s001ltr.pdf
2012-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022577s000ltr.pdf
2012-01-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s040,022577
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s047,022577
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021356Orig1s049,022577
Orig1s007ltr.pdf 2015-06-02 00:00:00
7565 1 022577 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021356Orig1s052,022577
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022578s001ltr.pdf
2011-12-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Orig1s001ltr.pdf
2012-11-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022581s000ltr.pdf
2011-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040010Orig1s008ltr.pdf
2014-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40032ltr.pdf
1999-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040099Orig1s018ltr.pdf
2014-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040148s053ltr.pdf
2015-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40168_Hydrocortisone
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40180ltr.pdf
1998-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40183ltr.pdf
1998-12-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40191ltr.pdf
1998-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40192ltr.pdf
1998-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40199_Oxycodone%20and
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40203ltr.pdf
1999-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40206ltr.pdf
1998-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40215ltr.pdf
1999-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40215ltr.pdf
1999-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40224ltr.pdf
1999-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40231ltr.pdf
1999-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40233ltr.pdf
1999-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40246ltr.pdf
2000-06-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40247ltr.pdf
1999-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40248ltr.pdf
2000-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40249ltr.pdf
1999-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40253ltr.pdf
2000-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40258ltr.pdf
1999-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40259ltr.pdf
1999-07-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40261ltr.pdf
1998-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40262ltr.pdf
1999-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40265ltr.pdf
1999-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40266ltr.pdf
1999-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40267ltr.pdf
1998-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40272ltr.pdf
1998-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40274ltr.pdf
1998-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40277ltr.pdf
2000-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40280ltr.pdf
1998-09-30 00:00:00
7603 1 040282 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040282Orig1s013ltr.pdf
2014-09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40283ltr.pdf
1998-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40284ltr.pdf
1998-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40287ltr.pdf
1999-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40289ltr.pdf
1999-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40291ltr.pdf
1999-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40296LTR.PDF
1999-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40298ltr.pdf
1998-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf
2003-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/40299ltr.pdf 1999-
05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40300ltr.pdf
1998-11-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40301ltr.pdf
1999-06-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40302ltr.pdf
1998-09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40304ltr.pdf
2000-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40307ltr.pdf
2000-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40309ltr.pdf
2000-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40310ltr.pdf
2000-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40312ltr.pdf
1999-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40316ltr.pdf
1999-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40317ltr.pdf
1999-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40318ltr.pdf
1999-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40320ltr.pdf
2000-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40330ltr..pdf
1999-06-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40331ltr.pdf
1999-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40322ltr.pdf
1999-06-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40036ltr.pdf
1999-08-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40337ltr.pdf
2000-02-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40341ltr.pdf
1999-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40350ltr.pdf
2000-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40351ltr.pdf
2000-07-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40352ltr.pdf
2000-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40353ltr.pdf
1999-07-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40359ltr.pdf
1999-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40360ltr.pdf
2001-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040361Orig1s017ltr.pdf
2014-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40364ltr.pdf
2003-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40368ltr.pdf
2000-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40373ltr.pdf
2000-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40378ltr.pdf
2000-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40385ltr.pdf
2001-03-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40388ltr.pdf
2001-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40391ltr.pdf
2003-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040391Orig1s007ltr.pdf
2014-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40397ltr.pdf
2000-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40398ltr.pdf
2003-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40400ltr.pdf
2000-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40402ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40403ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40405ltr.pdf
2000-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40409ltr.pdf
2000-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40412ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40420ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040422Orig1s033,s034lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/040422Orig1s038ltr.pdf
2015-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40424ltr.pdf
2003-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40427ltr.pdf
2003-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40431ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40439ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40444ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/040445s000ltr.pdf
2010-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40452ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40454ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40459ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40461ltr.pdf
2004-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40466ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40541ltr.pdf
2004-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040578ltr.pdf
2006-04-20 00:00:00
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7798 1 050542 SUPPL 21 0

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7,50754slr008,50761slr007ltr.pdf 2003-12-22 00:00:00
7799 1 050542 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024,
050754s011, 050760s010, 050761s010ltr.pdf 2008-06-13 00:00:00
7800 1 050542 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011,
050761s011,050754s012, 050542s025ltr.pdf 2008-04-02 00:00:00
7801 1 050542 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
7802 1 050545 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr03
3,50545slr037ltr.pdf 2003-06-08 00:00:00
7803 1 050545 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050545s051,052ltr.pdf
2005-07-29 00:00:00
7804 1 050545 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050545s053ltr.pdf
2008-04-22 00:00:00
7805 1 050547 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr03
0ltr.pdf 2004-06-24 00:00:00
7806 1 050547 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547s061ltr.pdf
2004-09-03 00:00:00
7807 1 050547 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050547s066ltr.pdf
2008-02-25 00:00:00
7808 1 050547 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037l
tr.pdf 2011-09-13 00:00:00
7809 1 050547 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596
Orig1s042ltr.pdf 2015-03-24 00:00:00
7810 1 050551 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50551slr042ltr.pdf
2004-05-28 00:00:00
7811 1 050551 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050551Orig1s043ltr.pdf
2015-03-19 00:00:00
7812 1 050555 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018
ltr.pdf 2003-03-26 00:00:00
7813 1 050555 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018
ltr.pdf 2003-03-26 00:00:00
7814 1 050555 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50555s021,022ltr.pdf
2004-07-21 00:00:00
7815 1 050558 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643
Orig1s022ltr.pdf 2014-09-29 00:00:00
7816 1 050564 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr01
5ltr.pdf 2003-08-15 00:00:00
7817 1 050564 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564s047,50720s019ltr
.pdf 2004-09-03 00:00:00
7818 1 050564 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050564s048,050721s021l
tr.pdf 2005-08-11 00:00:00
7819 1 050564 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s049,
050720s022ltr.pdf 2008-06-13 00:00:00
7820 1 050564 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr
27,29,50573slr21,23ltr.pdf 2004-06-17 00:00:00
7822 1 050573 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr
27,29,50573slr21,23ltr.pdf 2004-06-17 00:00:00
7823 1 050573 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574s
lr035,037,50625slr039,040ltr.pdf 2004-02-27 00:00:00
7824 1 050573 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,
050625s043ltr.pdf 2005-07-26 00:00:00
7825 1 050573 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,
050625s044ltr.pdf 2006-03-23 00:00:00
7826 1 050573 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,
050625s047ltr.pdf 2009-11-10 00:00:00
7827 1 050573 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,
050574s042ltr.pdf 2010-05-06 00:00:00
7828 1 050573 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574
Orig1s043,050625Orig1s049ltr.pdf 2012-09-05 00:00:00
7829 1 050574 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,
050625s043ltr.pdf 2005-07-26 00:00:00
7830 1 050575 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50
725s024,50726s018ltr.pdf 2004-08-12 00:00:00
7831 1 050575 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045,
050575s038, 050726s020, 050725s026ltr.pdf 2008-04-02 00:00:00
7832 1 050575 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf
2003-07-30 00:00:00
7835 1 050577 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf
2003-01-22 00:00:00
7836 1 050578 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf
2002-03-29 00:00:00
7837 1 050578 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s053,
050634s020ltr.pdf 2007-07-16 00:00:00
7838 1 050580 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50580s033ltr.pdf
2002-03-25 00:00:00
7839 1 050580 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50580s037,50632s012ltr
.pdf 2004-12-30 00:00:00
7840 1 050580 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050580s040ltr.pdf
2008-01-24 00:00:00
7841 1 050580 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050580Orig1s042ltr.pdf
2013-06-18 00:00:00
7842 1 050582 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50582s016ltr.pdf
2002-06-18 00:00:00
7843 1 050582 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050582s024ltr.pdf
2005-05-17 00:00:00
7844 1 050582 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050582s027ltr.pdf
2008-02-13 00:00:00
7845 1 050585 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585slr054ltr.pdf
2004-04-07 00:00:00
7846 1 050585 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s058ltr.pdf
2007-07-24 00:00:00
7847 1 050585 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s066ltr.pdf
2015-03-24 00:00:00
7848 1 050585 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s067ltr.pdf
2015-07-08 00:00:00
7849 1 050586 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf
2006-01-19 00:00:00
7850 1 050587 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50587sltr.pdf
1998-04-08 00:00:00
7851 1 050587 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf
2001-11-30 00:00:00
7852 1 050587 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr06
1ltr.pdf 2004-05-26 00:00:00
7853 1 050587 SUPPL 70 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s070,
050630s033ltr.pdf 2008-12-19 00:00:00
7854 1 050587 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050587s073ltr.pdf
2012-04-18 00:00:00
7855 1 050587 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050587Orig1s076ltr.pdf
2014-12-17 00:00:00
7856 1 050588 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr029ltr.pdf
2003-07-06 00:00:00
7857 1 050589 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr
.pdf 2005-01-21 00:00:00
7858 1 050590 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s057ltr.pdf
2008-04-22 00:00:00
7859 1 050590 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,
050590s059ltr.pdf 2010-12-28 00:00:00
7860 1 050590 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658
Orig1s029ltr.pdf 2013-10-01 00:00:00
7861 1 050590 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658
Orig1s031ltr.pdf 2014-06-17 00:00:00
7862 1 050591 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Or
ig1s015,50746Orig1s018ltr.pdf 2014-05-27 00:00:00
7863 1 050592 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50592slr032ltr.pdf
2003-07-06 00:00:00
7864 1 050596 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf
2002-01-18 00:00:00
7865 1 050596 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050596s035ltr.pdf
2008-02-25 00:00:00
7866 1 050596 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036l
tr.pdf 2009-06-02 00:00:00
7867 1 050596 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037l
tr.pdf 2011-09-13 00:00:00
7868 1 050597 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50
725s024,50726s018ltr.pdf 2004-08-12 00:00:00
7869 1 050597 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045,
050575s038, 050726s020, 050725s026ltr.pdf 2008-04-02 00:00:00
7870 1 050597 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,05
0575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022l
tr.pdf 2013-01-24 00:00:00
7871 1 050600 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr00
7,50615slr005ltr.pdf 2003-06-08 00:00:00
7872 1 050600 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537
Orig1s035,050615Orig1s012ltr.pdf 2014-04-07 00:00:00
7873 1 050600 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,
050615s014ltr.pdf 2016-01-20 00:00:00
7874 1 050605 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf
2002-03-29 00:00:00
7875 1 050605 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf
2002-04-11 00:00:00
7876 1 050605 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605slr037ltr.pdf
2002-07-24 00:00:00
7877 1 050606 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50606s015ltr.pdf
2002-05-24 00:00:00
7878 1 050606 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050606s028ltr.pdf
2011-12-15 00:00:00
7879 1 050608 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050608s040ltr.pdf
2012-03-13 00:00:00
7880 1 050608 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050608Orig1s041,s042lt
r.pdf 2014-11-19 00:00:00
7881 1 050609 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050609s025ltr.pdf
2008-02-29 00:00:00
7882 1 050609 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050609s032ltr.pdf
2011-06-13 00:00:00
7883 1 050609 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050609Orig1s034ltr.pdf
2013-08-22 00:00:00
7884 1 050611 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s029ltr.pdf
2008-01-09 00:00:00
7885 1 050611 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s030ltr.pdf
2008-05-28 00:00:00
7886 1 050611 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050611s031ltr.pdf
2010-11-08 00:00:00
7887 1 050611 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s032ltr.pdf
2008-12-19 00:00:00
7888 1 050615 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr00
2,50615slr003ltr.pdf 2002-07-14 00:00:00
7889 1 050615 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,
050615s014ltr.pdf 2016-01-20 00:00:00
7890 1 050616 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019
ltr.pdf 2004-06-28 00:00:00
7891 1 050616 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf
2004-07-21 00:00:00
7892 1 050619 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/r_50619slr004ltr.pdf
2003-05-29 00:00:00
7893 1 050621 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50621slr023,50622slr01
7ltr.pdf 2004-04-07 00:00:00
7894 1 050624 SUPPL 26 0

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.pdf 2004-09-03 00:00:00
7895 1 050625 SUPPL 30 0

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27,29,50573slr21,23ltr.pdf 2004-06-17 00:00:00
7896 1 050625 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr
27,29,50573slr21,23ltr.pdf 2004-06-17 00:00:00
7897 1 050625 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,
050625s043ltr.pdf 2005-07-26 00:00:00
7898 1 050625 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574
Orig1s043,050625Orig1s049ltr.pdf 2012-09-05 00:00:00
7899 1 050627 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr
.pdf 2004-08-25 00:00:00
7900 1 050627 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012l
tr.pdf 2010-11-22 00:00:00
7901 1 050629 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629s
lr010,013ltr.pdf 2002-09-25 00:00:00
7902 1 050629 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629s
lr010,013ltr.pdf 2002-09-25 00:00:00
7903 1 050629 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-
014slr016,50467se1-068,slr069ltr.pdf 2003-05-30 00:00:00
7904 1 050629 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050467s070,050629s017l
tr.pdf 2010-08-09 00:00:00
7905 1 050629 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050467s071,050629s019l
tr.pdf 2011-09-29 00:00:00
7906 1 050629 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050629Orig1s022ltr.pdf
2013-11-06 00:00:00
7907 1 050630 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr06
1ltr.pdf 2004-05-26 00:00:00
7908 1 050630 SUPPL 26 0
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050630s026LTR.pdf 2006-08-07 00:00:00
7909 1 050630 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s065,
050630s028ltr.pdf 2008-04-02 00:00:00
7910 1 050632 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50632s10ltr.pdf
1998-12-24 00:00:00
7911 1 050632 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050632s013ltr.pdf
2008-01-24 00:00:00
7912 1 050632 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050632Orig1s015ltr.pdf
2013-06-18 00:00:00
7913 1 050634 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50578slr046,50634slr01
6ltr.pdf 2004-05-26 00:00:00
7914 1 050638 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050638s016ltr.pdf
2012-04-18 00:00:00
7915 1 050639 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50
639s013ltr.pdf 2004-10-04 00:00:00
7916 1 050639 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016l
tr.pdf 2008-04-16 00:00:00
7917 1 050639 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,
050639s022ltr.pdf 2011-06-10 00:00:00
7918 1 050639 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s
029ltr.pdf 2014-06-27 00:00:00
7919 1 050639 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s
029ltr.pdf 2014-06-27 00:00:00
7920 1 050640 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50640slr006ltr.pdf
2002-08-23 00:00:00
7921 1 050640 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050640s010ltr.pdf
2008-04-22 00:00:00
7922 1 050640 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050640s011ltr.pdf
2011-10-17 00:00:00
7923 1 050640 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050640Orig1s015ltr.pdf
2012-11-23 00:00:00
7924 1 050641 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s013ltr.pdf
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2002-02-01 00:00:00
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2002-02-01 00:00:00
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2002-05-31 00:00:00
7931 1 050649 SUPPL 16 0

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2004-06-01 00:00:00
7932 1 050649 SUPPL 18 0

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050649s018ltr.pdf 2005-10-20 00:00:00
7933 1 050649 SUPPL 19 0

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2007-04-09 00:00:00
7934 1 050649 SUPPL 20 0

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2007-02-02 00:00:00
7935 1 050649 SUPPL 22 0

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2002-08-23 00:00:00
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2011-11-14 00:00:00
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2002-03-18 00:00:00
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.pdf 2004-12-02 00:00:00
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050658s021ltr.pdf 2008-12-19 00:00:00
7941 1 050658 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,
050590s059ltr.pdf 2010-12-28 00:00:00
7942 1 050658 SUPPL 24 0

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s024ltr.pdf 2011-06-13 00:00:00
7943 1 050658 SUPPL 31 0

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Orig1s031ltr.pdf 2014-06-17 00:00:00
7944 1 050661 SUPPL 7 0

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2002-09-30 00:00:00
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2002-10-11 00:00:00
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2002-06-06 00:00:00
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s026,s030,050775s015,s019ltr.pdf 2012-05-09 00:00:00
7948 1 050662 SUPPL 45 0

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s025,s027,050775s014,s016ltr.pdf 2011-05-31 00:00:00
7949 1 050662 SUPPL 46 0

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050775s017lltr.pdf 2012-06-05 00:00:00
7950 1 050662 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698
s026,s030,050775s015,s019ltr.pdf 2012-05-09 00:00:00
7951 1 050662 SUPPL 53 0

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50698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 2013-09-11 00:00:00
7952 1 050662 SUPPL 54 0

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Orig1s033,050775Orig1s022ltr.pdf 2016-05-31 00:00:00
7953 1 050662 SUPPL 55 0

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Orig1s035,050775Orig1s023ltr.pdf 2014-07-28 00:00:00
7954 1 050662 SUPPL 56 0

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Orig1s036,050775Orig1s024ltr.pdf 2015-01-09 00:00:00
7955 1 050664 SUPPL 23 0

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3ltr.pdf 2004-06-25 00:00:00
7956 1 050665 SUPPL 12 0

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2004-06-09 00:00:00
7957 1 050665 SUPPL 24 0
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050665s024ltr.pdf 2007-09-25 00:00:00
7958 1 050670 SUPPL 15 0
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670S015_Zithromax_Approv.pdf 2000-11-13 00:00:00
7959 1 050670 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr00
5,50730slr007ltr.pdf 2002-10-16 00:00:00
7960 1 050670 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf
2002-07-22 00:00:00
7961 1 050670 SUPPL 21 0

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8,50730slr011ltr.pdf 2004-03-28 00:00:00
7962 1 050670 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr00
9,50730slr012ltr.pdf 2004-01-22 00:00:00
7963 1 050671 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50671slr006ltr.pdf
2004-04-07 00:00:00
7964 1 050671 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050671s012ltr.pdf
2008-05-07 00:00:00
7965 1 050671 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050671s018ltr.pdf
2012-01-19 00:00:00
7966 1 050671 SUPPL 22 0

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2015-12-22 00:00:00
7967 1 050672 SUPPL 13 0
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2002-03-29 00:00:00
7968 1 050672 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050672s028ltr.pdf
2007-08-02 00:00:00
7969 1 050674 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50674s12ltr.pdf
1998-11-20 00:00:00
7970 1 050674 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50675slr013,016ltr.pdf
2004-06-07 00:00:00
7971 1 050675 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf
1998-11-20 00:00:00
7972 1 050675 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50675slr013,016ltr.pdf
2004-06-07 00:00:00
7973 1 050675 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050674s014,
050675s017ltr.pdf 2007-06-07 00:00:00
7974 1 050675 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050674Orig1s015,050675
Orig1s018ltr.pdf 2013-06-24 00:00:00
7975 1 050678 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50678s010ltr.pdf
2004-06-02 00:00:00
7976 1 050679 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_Approv.pdf
1999-01-27 00:00:00
7977 1 050679 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr
.pdf 2002-08-21 00:00:00
7978 1 050679 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr
.pdf 2002-08-21 00:00:00
7979 1 050679 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50679se2-
021ltr.pdf 2003-03-26 00:00:00
7980 1 050679 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50679slr023ltr.pdf
2004-06-10 00:00:00
7981 1 050679 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050679s032ltr.pdf
2009-11-20 00:00:00
7982 1 050679 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050679Orig1s036ltr.pdf
2012-09-10 00:00:00
7983 1 050679 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050679Orig1s040ltr.pdf
2016-03-03 00:00:00
7984 1 050680 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680s002_appltr.pdf
1998-03-02 00:00:00
7985 1 050680 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50680slr004ltr.pdf
2003-08-29 00:00:00
7986 1 050680 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767
Orig1s012ltr.pdf 2015-07-15 00:00:00
7987 1 050682 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50682slr020ltr.pdf
2003-03-26 00:00:00
7988 1 050682 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50682s021ltr.pdf
2004-12-06 00:00:00
7989 1 050682 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050682s022ltr.pdf
2005-08-19 00:00:00
7990 1 050682 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050682s025ltr.pdf
2009-03-17 00:00:00
7991 1 050682 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf
2012-02-07 00:00:00
7992 1 050684 SUPPL 15 0
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2002-03-27 00:00:00
7993 1 050684 SUPPL 33 0
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033ltr.pdf 2003-05-29 00:00:00
7994 1 050684 SUPPL 35 0
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7995 1 050684 SUPPL 39 0

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.pdf 2005-03-18 00:00:00
7996 1 050684 SUPPL 44 0

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tr.pdf 2005-06-29 00:00:00
7997 1 050684 SUPPL 46 0

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s052ltr.pdf 2008-04-22 00:00:00
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tr.pdf 2011-10-03 00:00:00
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080,050750Orig1s021,s026,s030ltr.pdf 2013-09-11 00:00:00
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050750Orig1s033ltr.pdf 2015-12-22 00:00:00
8002 1 050684 SUPPL 86 0

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tr.pdf 2009-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF
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8010 1 050688 SUPPL 10 0

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2015-07-09 00:00:00
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670S015_Zithromax_Approv.pdf 2000-11-13 00:00:00
8016 1 050693 SUPPL 5 0

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8019 1 050693 SUPPL 15 0

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tr.pdf 2010-08-17 00:00:00
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00:00:00
8021 1 050693 SUPPL 22 0

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050711s035,050730s030,050733s034,050784s022ltr.pdf 2012-06-08 00:00:00
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698s019,50775s007ltr.pdf 2004-07-21 00:00:00
8023 1 050698 SUPPL 14 0
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698s019,50775s007ltr.pdf 2004-07-21 00:00:00
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050698s021, 050775s009LTR.pdf 2006-07-13 00:00:00
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050775s013ltr.pdf 2009-11-20 00:00:00
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8032 1 050698 SUPPL 31 0

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8034 1 050703 SUPPL 15 0

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ig1s015,50746Orig1s018ltr.pdf 2014-05-27 00:00:00
8035 1 050703 SUPPL 16 0

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2008-04-02 00:00:00
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2009-11-20 00:00:00
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r.pdf 2013-12-17 00:00:00
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tr.pdf 2005-12-16 00:00:00
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8068 1 050710 SUPPL 33 0

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1s031,050730s026,050733s030,050784s018ltr.pdf 2011-02-03 00:00:00
8069 1 050710 SUPPL 43 0

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050784s012ltr.pdf 2009-03-03 00:00:00
8074 1 050711 SUPPL 31 0

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050711s031,050730s026,050733s030,050784s018ltr.pdf 2011-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s028ltr.pdf
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Orig1s038ltr.pdf 2015-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50719slr06ltr.pdf
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.pdf 2004-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050720s024ltr.pdf
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00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,
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58s14,50759s19ltr.pdf 2007-09-25 00:00:00
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050758s019,050759s024ltr.pdf 2009-06-23 00:00:00
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050758s026,050759s033ltr.pdf 2012-06-26 00:00:00
8123 1 050723 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,0
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00:00:00
8124 1 050723 SUPPL 32 0

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Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf 2015-07-14 00:00:00
8125 1 050725 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr04
2,50725slr023,50726slr017ltr.pdf 2004-06-07 00:00:00
8126 1 050725 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50
725s024,50726s018ltr.pdf 2004-08-12 00:00:00
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050725s027,050726s021ltr.pdf 2011-10-04 00:00:00
8128 1 050726 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr04
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8129 1 050726 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50
725s024,50726s018ltr.pdf 2004-08-12 00:00:00
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050597s044, 050725025, 050726s019ltr.pdf 2008-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,
050725s027,050726s021ltr.pdf 2011-10-04 00:00:00
8132 1 050726 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf
2002-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024,
050693s010, 050730s014ltr.pdf 2007-11-08 00:00:00
8135 1 050730 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021l
tr.pdf 2009-03-10 00:00:00
8136 1 050730 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025l
tr.pdf 2010-08-17 00:00:00
8137 1 050730 SUPPL 29 0

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Orig1s029ltr.pdf 2014-06-11 00:00:00
8138 1 050730 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,
050711s035,050730s030,050733s034,050784s022ltr.pdf 2012-06-08 00:00:00
8139 1 050730 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730
Orig1s031ltr.pdf 2013-02-21 00:00:00
8140 1 050733 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733s9ltr.pdf
2002-03-13 00:00:00
8141 1 050733 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf
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2004-01-22 00:00:00
8143 1 050733 SUPPL 30 0

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8144 1 050733 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050733Orig1s035ltr.pdf
2013-02-21 00:00:00
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2003-05-30 00:00:00
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2014-12-05 00:00:00
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2002-07-24 00:00:00
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050749s018ltr.pdf 2007-09-25 00:00:00
8149 1 050739 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015,
050749s021ltr.pdf 2008-12-19 00:00:00
8150 1 050740 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-
740S001_AmBisome_Approv.pdf 2000-01-28 00:00:00
8151 1 050740 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50740S2LTR.PDF
2000-07-18 00:00:00
8152 1 050740 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050740s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50741ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741slr003ltr.pdf
2003-10-24 00:00:00
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2010-11-10 00:00:00
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2011-12-28 00:00:00
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2013-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf
2004-02-27 00:00:00
8159 1 050742 SUPPL 17 0

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2006-01-30 00:00:00
8160 1 050742 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s020ltr.pdf
2008-02-27 00:00:00
8161 1 050742 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019,
050742s021ltr.pdf 2007-10-04 00:00:00
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2009-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf
2009-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50744ltr.pdf
1998-09-30 00:00:00
8165 1 050746 SUPPL 13 0

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2015-03-20 00:00:00
8166 1 050746 SUPPL 18 0

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ig1s015,50746Orig1s018ltr.pdf 2014-05-27 00:00:00
8167 1 050747 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50747ltr.pdf
1999-09-21 00:00:00
8168 1 050748 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050747s008,050748s008l
tr.pdf 2008-06-20 00:00:00
8169 1 050748 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,
050748s010ltr.pdf 2010-11-22 00:00:00
8170 1 050749 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s010ltr.pdf
2004-07-30 00:00:00
8171 1 050749 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013l
tr.pdf 2005-07-21 00:00:00
8172 1 050749 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013,
050749s017ltr.pdf 2007-07-05 00:00:00
8173 1 050749 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749
Orig1s023ltr.pdf 2015-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50750s003ltr.pdf
2002-03-27 00:00:00
8175 1 050750 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50684s039,50750s009ltr
.pdf 2005-03-18 00:00:00
8176 1 050750 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s044,050750s011l
tr.pdf 2005-06-29 00:00:00
8177 1 050750 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050684s061,050750s016l
tr.pdf 2012-05-15 00:00:00
8178 1 050750 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s
080,050750Orig1s021,s026,s030ltr.pdf 2013-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050684s071,050750s024l
tr.pdf 2011-10-03 00:00:00
8180 1 050750 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s
080,050750Orig1s021,s026,s030ltr.pdf 2013-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050684Orig1s083;
050750Orig1s033ltr.pdf 2015-12-22 00:00:00
8182 1 050750 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,0
50750Orig1s034,s035ltr.pdf 2016-06-13 00:00:00
8183 1 050751 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50751ltr.pdf
1998-09-04 00:00:00
8184 1 050751 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50751scs011ltr.pdf
2003-07-06 00:00:00
8185 1 050751 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050751s013ltr.pdf
2009-06-10 00:00:00
8186 1 050753 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050753s009ltr.pdf
2008-10-22 00:00:00
8187 1 050753 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050753Orig1s018ltr.pdf
2015-10-06 00:00:00
8188 1 050754 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50542s16ltr.pdf
2004-05-27 00:00:00
8189 1 050754 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr00
4,50760slr003,50761slr003ltr.pdf 2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024,
050754s011, 050760s010, 050761s010ltr.pdf 2008-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011,
050761s011,050754s012, 050542s025ltr.pdf 2008-04-02 00:00:00
8193 1 050754 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
8195 1 050754 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754
Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 2015-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s012ltr.pdf
2004-12-30 00:00:00
8197 1 050755 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050755s014ltr.pdf
2009-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050755s015ltr.pdf
2008-04-22 00:00:00
8199 1 050755 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785
s009ltr.pdf 2011-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050755Orig1s022ltr.pdf
2015-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-
756_Benzaclin_Approv.pdf 2000-12-21 00:00:00
8202 1 050756 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50756scp007ltr.pdf
2002-08-09 00:00:00
8203 1 050756 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050756s034ltr.pdf
2009-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050756s037ltr.pdf
2010-06-18 00:00:00
8205 1 050756 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050756s040ltr.pdf
2011-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50757s2ltr.pdf
1999-01-22 00:00:00
8207 1 050757 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50757s009,010ltr.pdf
2004-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012,
050757s013LTR.pdf 2006-08-14 00:00:00
8209 1 050757 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s014ltr.pdf
2007-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s015ltr.pdf
2007-11-08 00:00:00
8211 1 050757 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050757s016ltr.pdf
2009-04-03 00:00:00
8212 1 050757 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050757Orig1s019ltr.pdf
2014-12-23 00:00:00
8213 1 050758 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050758s010ltr.pdf
2005-04-19 00:00:00
8214 1 050758 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,
050758s013,050759s018ltr.pdf 2008-01-09 00:00:00
8215 1 050758 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,507
58s14,50759s19ltr.pdf 2007-09-25 00:00:00
8216 1 050758 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019,
050723s017, 050758s017, 050759s022ltr.pdf 2008-12-24 00:00:00
8217 1 050758 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,
050758s026,050759s033ltr.pdf 2012-06-26 00:00:00
8218 1 050758 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,0
50723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 2013-10-01
00:00:00
8219 1 050759 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50759ltr.pdf
1998-10-01 00:00:00
8220 1 050759 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF
2000-07-28 00:00:00
8221 1 050759 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr00
5,50723slr006,50722slr008ltr.pdf 2003-03-10 00:00:00
8222 1 050759 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_
050758s016_050759s021ltr.pdf 2008-05-15 00:00:00
8223 1 050759 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,
050758s018,050759s023ltr.pdf 2009-03-05 00:00:00
8224 1 050759 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,
050758s019,050759s024ltr.pdf 2009-06-23 00:00:00
8225 1 050759 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723
Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf 2012-09-27 00:00:00
8226 1 050759 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,
050758s024,050759s031ltr.pdf 2012-06-12 00:00:00
8227 1 050759 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,0
50723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 2013-10-01
00:00:00
8228 1 050759 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723
Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf 2015-07-14 00:00:00
8229 1 050760 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024,
050754s011, 050760s010, 050761s010ltr.pdf 2008-06-13 00:00:00
8230 1 050760 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011,
050761s011,050754s012, 050542s025ltr.pdf 2008-04-02 00:00:00
8231 1 050760 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
8232 1 050760 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754O
rig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 2015-09-28 00:00:00
8233 1 050760 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754
Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 2015-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50761ltr.pdf
2004-05-27 00:00:00
8235 1 050761 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr00
4,50760slr003,50761slr003ltr.pdf 2003-06-08 00:00:00
8236 1 050761 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr00
7,50754slr008,50761slr007ltr.pdf 2003-12-22 00:00:00
8237 1 050761 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50
760s008,50761s008rltr.pdf 2004-07-21 00:00:00
8238 1 050761 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050761s009_050760s009l
tr.pdf 2006-01-30 00:00:00
8239 1 050761 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
8240 1 050761 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
8241 1 050761 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
8242 1 050761 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754O
rig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 2015-09-28 00:00:00
8243 1 050762 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050762a_appltr_prntlbl.pdf
1998-12-28 00:00:00
8244 1 050767 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767
Orig1s011ltr.pdf 2014-05-12 00:00:00
8245 1 050767 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767
Orig1s012ltr.pdf 2015-07-15 00:00:00
8246 1 050775 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50775ltr.pdf
2000-03-03 00:00:00
8247 1 050775 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50775s1ltr.pdf
2001-08-03 00:00:00
8248 1 050775 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50775slr004ltr.pdf
2003-04-18 00:00:00
8249 1 050775 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50
698s019,50775s007ltr.pdf 2004-07-21 00:00:00
8250 1 050775 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040,
050698s022, 050775s011ltr.pdf 2008-01-09 00:00:00
8251 1 050775 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,
050775s013ltr.pdf 2009-11-20 00:00:00
8252 1 050775 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698
s025,s027,050775s014,s016ltr.pdf 2011-05-31 00:00:00
8253 1 050775 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698
s026,s030,050775s015,s019ltr.pdf 2012-05-09 00:00:00
8254 1 050775 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698
s025,s027,050775s014,s016ltr.pdf 2011-05-31 00:00:00
8255 1 050775 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,
050775s017lltr.pdf 2012-06-05 00:00:00
8256 1 050775 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,0
50698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 2013-09-11 00:00:00
8257 1 050775 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,0
50698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 2013-09-11 00:00:00
8258 1 050775 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698
Orig1s035,050775Orig1s023ltr.pdf 2014-07-28 00:00:00
8259 1 050777 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scp004ltr.pdf
2003-05-29 00:00:00
8260 1 050777 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scs006ltr.pdf
2003-12-24 00:00:00
8261 1 050777 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050777s014ltr.pdf
2009-01-06 00:00:00
8262 1 050778 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf
2003-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50778s008ltr.pdf
2005-03-10 00:00:00
8264 1 050778 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018lt
r.pdf 2011-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050778Orig1s019ltr.pdf
2013-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050778Orig1s021ltr.pdf
2014-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50779ltr.pdf
2000-08-04 00:00:00
8268 1 050779 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50779slr005ltr.pdf
2004-07-01 00:00:00
8269 1 050779 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050779s011ltr.pdf
2008-11-07 00:00:00
8270 1 050779 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050779s013ltr.pdf
2007-09-11 00:00:00
8271 1 050780 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_approv.pdf
2001-02-21 00:00:00
8272 1 050780 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50780slr005ltr.pdf
2003-08-29 00:00:00
8273 1 050780 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050780s011ltr.pdf
2007-09-11 00:00:00
8274 1 050781 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050781s012ltr.pdf
2008-02-20 00:00:00
8275 1 050781 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050781Orig1s019ltr.pdf
2012-07-31 00:00:00
8276 1 050783 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50783ltr.pdf
2001-02-02 00:00:00
8277 1 050783 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50783slr002ltr.pdf
2004-04-07 00:00:00
8278 1 050784 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784ltr.pdf
2002-05-24 00:00:00
8279 1 050784 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784slr002ltr.pdf
2002-10-16 00:00:00
8280 1 050784 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr02
0,50784slr005ltr.pdf 2003-12-22 00:00:00
8281 1 050784 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023,
050711s019, 050784s007ltr.pdf 2007-11-08 00:00:00
8282 1 050784 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,
050711s031,050730s026,050733s030,050784s018ltr.pdf 2011-02-03 00:00:00
8283 1 050784 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,
050711s035,050730s030,050733s034,050784s022ltr.pdf 2012-06-08 00:00:00
8284 1 050785 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785slr002ltr.pdf
2003-06-08 00:00:00
8285 1 050785 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785slr004ltr.pdf
2004-05-26 00:00:00
8286 1 050785 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785s005ltr.pdf
2004-09-17 00:00:00
8287 1 050785 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s007ltr.pdf
2008-12-19 00:00:00
8288 1 050785 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785
s009ltr.pdf 2011-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050797Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/063009Orig1s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150aplet.pdf 2011-
03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/64163ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64180ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/65002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65004LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65066ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65068Ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65076ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65087ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065259s000LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065262s000LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065264s000LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065374ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065386s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065396s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065490s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/071297Orig1s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/071881Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073193Orig1s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073210Orig1s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74253S1&2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74278ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74415ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74432ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74446ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74464ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74504TA.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74507ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75513ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74530ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75542ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74552ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74555LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74567ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74657ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/74681ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74688ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74699ltr.pdf
2000-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/074703s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74713ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74726ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74737ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74751ltr.pdf
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1998-07-02 00:00:00
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2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74812ta.pdf 2004-06-14
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74814ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74847ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/074848ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74862ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74904ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74931ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/074978Orig1s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74989ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75048ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75099APltr.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75103ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75106ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75107ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75108ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75111ltr.pdf
1999-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75119ta.pdf
2004-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75119ltr.pdf
2003-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75126ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75138ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75152ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75153ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75154ta.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75155ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075155Orig1s034ltr.pdf
2014-10-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75160ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75164ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75182ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75182
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Approv.pdf
2004-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75185ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75189ta.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75190ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75192ta.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75199ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75201ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75205ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75208ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75209altr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75213ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75217ltr.pdf
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1999-08-23 00:00:00
8569 1 075221 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75221ltr.pdf
1999-10-28 00:00:00
8570 1 075225 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75225ltr.pdf
1999-10-20 00:00:00
8571 1 075229 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75229ltr.pdf
1998-11-20 00:00:00
8572 1 075230 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75230ltr.pdf
1999-11-25 00:00:00
8573 1 075235 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75235ltr.pdf
2000-01-27 00:00:00
8574 1 075237 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75237ta.pdf
2004-06-18 00:00:00
8575 1 075237 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75237ltr.pdf
2000-05-01 00:00:00
8576 1 075238 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75238ta.pdf
2004-06-18 00:00:00
8577 1 075239 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75239ltr.pdf
2004-06-08 00:00:00
8578 1 075242 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75242ltr.pdf
2004-06-08 00:00:00
8579 1 075243 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75243ltr.pdf
2000-06-20 00:00:00
8580 1 075247 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75247ta.pdf
2004-06-09 00:00:00
8581 1 075249 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75249ltr.pdf
2000-06-23 00:00:00
8582 1 075250 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75250wd.pdf
2003-04-10 00:00:00
8583 1 075252 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75252ltr.pdf
1999-06-07 00:00:00
8584 1 075256 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75256ltr.pdf
1999-08-12 00:00:00
8585 1 075256 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel
%20and%20Ethinyl_Approv.pdf 2004-06-02 00:00:00
8586 1 075256 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel
%20and%20Ethinyl_Approv.pdf 2004-06-02 00:00:00
8587 1 075256 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel
%20and%20Ethinyl_Approv.pdf 2004-06-02 00:00:00
8588 1 075260 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75260ltr.pdf
1999-01-25 00:00:00
8589 1 075269 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75269ta.pdf
2004-06-10 00:00:00
8590 1 075270 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75270ltr.pdf
1999-03-24 00:00:00
8591 1 075271 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75271ltr.pdf
2000-01-18 00:00:00
8592 1 075273 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75273ltr.pdf
1999-06-15 00:00:00
8593 1 075274 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75274ltr.pdf
1999-05-26 00:00:00
8594 1 075276 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/75276_Betamethasone
%20Dipropionate_Approv.pdf 2003-12-23 00:00:00
8595 1 075280 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75280taltr.pdf
2004-06-09 00:00:00
8596 1 075280 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75280ltr.pdf
2003-04-10 00:00:00
8597 1 075282 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75282ltr.pdf
1999-06-16 00:00:00
8598 1 075285 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75285ltr.pdf
1998-10-29 00:00:00
8599 1 075286 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75286ltr.pdf
1999-06-30 00:00:00
8600 1 075288 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75288ltr.pdf
1999-07-28 00:00:00
8601 1 075289 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75289S1Ltr.pdf
2001-02-06 00:00:00
8602 1 075290 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75290ltr.pdf
2001-04-30 00:00:00
8603 1 075293 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75293ta.pdf
2004-06-09 00:00:00
8604 1 075297 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75297ltr.pdf
2001-03-27 00:00:00
8605 1 075298 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75298TA.pdf
2004-06-04 00:00:00
8606 1 075299 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75229ltr.pdf
1999-11-03 00:00:00
8607 1 075300 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75300ta.pdf
2004-06-28 00:00:00
8608 1 075302 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75302ltr.pdf
2001-04-16 00:00:00
8609 1 075303 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75303ltr.pdf
1999-05-28 00:00:00
8610 1 075309 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75309ltr.pdf
2000-04-26 00:00:00
8611 1 075311 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75311ltr.pdf
2001-04-16 00:00:00
8612 1 075315 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75315ltr.pdf
1998-12-23 00:00:00
8613 1 075315 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf
2000-06-30 00:00:00
8614 1 075315 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.p
df 2000-04-12 00:00:00
8615 1 075316 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75316ltr.pdf
1999-11-02 00:00:00
8616 1 075318 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75318ltr.pdf
1999-08-20 00:00:00
8617 1 075319 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75319ltr.pdf
1999-06-15 00:00:00
8618 1 075321 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75321ltr.pdf
1998-12-04 00:00:00
8619 1 075323 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75323ltr.pdf
2000-04-21 00:00:00
8620 1 075326 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75326ltr.pdf
1999-08-20 00:00:00
8621 1 075327 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75327ltr.pdf
1999-03-24 00:00:00
8622 1 075329 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75329ltr.pdf
1999-04-20 00:00:00
8623 1 075337 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75337ltr.pdf
1999-05-26 00:00:00
8624 1 075340 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75340ltr.pdf
1999-02-24 00:00:00
8625 1 075341 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75341ltr.pdf
1999-07-27 00:00:00
8626 1 075343 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75343ltr.pdf
1999-11-09 00:00:00
8627 1 075347 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75347ta.pdf
2004-06-10 00:00:00
8628 1 075348 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75348ltr.pdf
2000-11-29 00:00:00
8629 1 075352 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75352ltr.pdf
1998-11-30 00:00:00
8630 1 075357 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75357ltr.pdf
1999-07-30 00:00:00
8631 1 075361 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75361ltr.pdf
2000-10-05 00:00:00
8632 1 075362 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75362ltr.pdf
1999-06-15 00:00:00
8633 1 075363 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75363Ltr.pdf
2000-12-29 00:00:00
8634 1 075366 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75366ltr.pdf
2000-05-01 00:00:00
8635 1 075368 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75368ltr.pdf
2000-02-15 00:00:00
8636 1 075369 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75370ta.pdf
2004-06-28 00:00:00
8637 1 075371 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75371ltr.pdf
1999-08-27 00:00:00
8638 1 075373 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75373ltr.pdf
1999-06-22 00:00:00
8639 1 075379 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75379ltr.pdf
2000-12-15 00:00:00
8640 1 075383 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75383ltr.pdf
1999-11-22 00:00:00
8641 1 075385 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75388TA.pdf
2004-05-28 00:00:00
8642 1 075386 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75386ltr.pdf
2000-06-30 00:00:00
8643 1 075389 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75389ltr.pdf
2001-01-25 00:00:00
8644 1 075392 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75392ltr.pdf
2000-09-19 00:00:00
8645 1 075393 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75393ltr.pdf 1999-
05-11 00:00:00
8646 1 075395 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75395ltr.pdf
2000-03-16 00:00:00
8647 1 075396 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75396ltr.pdf
2000-06-20 00:00:00
8648 1 075401 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75401TA.pdf
2004-06-18 00:00:00
8649 1 075402 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75402ltr.pdf
2001-02-28 00:00:00
8650 1 075403 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75403ltr.pdf
2001-02-28 00:00:00
8651 1 075404 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75404ltr.pdf
2004-06-04 00:00:00
8652 1 075405 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75405ta.pdf
2004-06-01 00:00:00
8653 1 075405 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75405ltr.pdf
2000-02-28 00:00:00
8654 1 075406 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075406Orig1s016ltr.pdf
2013-04-24 00:00:00
8655 1 075407 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75407ltr.pdf
2000-01-28 00:00:00
8656 1 075409 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75409ta.pdf
2004-06-09 00:00:00
8657 1 075410 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75410TA.pdf
2004-06-28 00:00:00
8658 1 075412 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75412ltr.pdf
2000-09-08 00:00:00
8659 1 075413 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75413ltr.pdf
2003-04-10 00:00:00
8660 1 075414 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/075414s000_ltr.pdf
2007-02-12 00:00:00
8661 1 075417 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.p
df 2010-04-28 00:00:00
8662 1 075417 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.p
df 2010-04-28 00:00:00
8663 1 075419 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75419ltr.pdf
2000-07-28 00:00:00
8664 1 075421 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75421ta.pdf
2004-06-09 00:00:00
8665 1 075421 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75421ltr.pdf
2000-06-20 00:00:00
8666 1 075424 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75424ltr.pdf
2001-03-30 00:00:00
8667 1 075425 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75425ltr.pdf
1999-07-29 00:00:00
8668 1 075426 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75426ltr.pdf
2000-10-18 00:00:00
8669 1 075435 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75435ltr.pdf
2004-10-08 00:00:00
8670 1 075439 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75439ltr.pdf
2000-04-19 00:00:00
8671 1 075440 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75440ltr.pdf
2000-02-28 00:00:00
8672 1 075440 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/075440s023ltr.pdf
2008-01-09 00:00:00
8673 1 075441 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75441ltr.pdf
2001-03-28 00:00:00
8674 1 075455 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75455ltr.pdf
2000-06-20 00:00:00
8675 1 075456 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75456ta.pdf
2004-06-28 00:00:00
8676 1 075457 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75457ta.pdf
2004-06-04 00:00:00
8677 1 075458 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75456ta.pdf
2004-06-28 00:00:00
8678 1 075464 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75464TA.pdf
2004-06-04 00:00:00
8679 1 075465 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Approv.pdf
2004-06-04 00:00:00
8680 1 075466 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75466ltr.pdf
2000-10-18 00:00:00
8681 1 075467 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf
2003-04-10 00:00:00
8682 1 075469 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75469ta.pdf
2004-05-28 00:00:00
8683 1 075475 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75475ltr.pdf
2000-08-03 00:00:00
8684 1 075480 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75480ltr.pdf
2000-08-22 00:00:00
8685 1 075480 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75480ta.pdf
2004-06-03 00:00:00
8686 1 075482 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75482ltr.pdf
2000-08-22 00:00:00
8687 1 075482 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75482ta.pdf
2004-06-03 00:00:00
8688 1 075486 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75486ltr.pdf
2001-04-16 00:00:00
8689 1 075488 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75488ltr.pdf
2001-04-16 00:00:00
8690 1 075491 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75491ltr.pdf
2000-04-17 00:00:00
8691 1 075492 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75492ltr.pdf
2000-02-11 00:00:00
8692 1 075494 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75494ltr.pdf
2000-06-30 00:00:00
8693 1 075496 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75459ltr.pdf
2004-06-03 00:00:00
8694 1 075497 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75497ltr.pdf
2000-01-14 00:00:00
8695 1 075498 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75498ltr.pdf
2001-04-12 00:00:00
8696 1 075501 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75501ta.pdf
2004-06-03 00:00:00
8697 1 075503 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/075503s000ltr.pdf
2006-10-02 00:00:00
8698 1 075504 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75504ltr.pdf
2003-04-10 00:00:00
8699 1 075505 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75505apltr.pdf
2003-12-12 00:00:00
8700 1 075507 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75507ltr.pdf
2001-01-19 00:00:00
8701 1 075508 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75508ltr.pdf
2000-04-24 00:00:00
8702 1 075510 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75510TAPF2.pdf
2004-06-28 00:00:00
8703 1 075515 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75515ltr.pdf
2003-04-14 00:00:00
8704 1 075518 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75518ta.pdf
2004-06-09 00:00:00
8705 1 075518 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75518ltr.pdf
2000-11-17 00:00:00
8706 1 075521 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75521TA.pdf
2004-05-28 00:00:00
8707 1 075521 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75521.ap.pdf
2003-04-10 00:00:00
8708 1 075524 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75524ltr.pdf
1999-11-29 00:00:00
8709 1 075527 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ta.pdf
2004-05-28 00:00:00
8710 1 075529 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75529ltr.pdf
2000-02-22 00:00:00
8711 1 075530 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75530ta.pdf
2004-06-09 00:00:00
8712 1 075536 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75536ltr.pdf
2000-10-18 00:00:00
8713 1 075541 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075541Orig1s010ltr.pdf
2014-12-31 00:00:00
8714 1 075547 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75547ltr.pdf
2001-04-02 00:00:00
8715 1 075558 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75558.ap.pdf
2003-04-14 00:00:00
8716 1 075559 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75559ltr.pdf
2000-03-20 00:00:00
8717 1 075569 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75569ltr.pdf
2003-04-14 00:00:00
8718 1 075571 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75571ltr.pdf
2000-08-22 00:00:00
8719 1 075571 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75571ta.pdf
2004-06-03 00:00:00
8720 1 075572 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75572ap.pdf
2003-04-10 00:00:00
8721 1 075578 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75578ta.pdf
2004-06-03 00:00:00
8722 1 075579 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75579ltr.pdf
2000-09-25 00:00:00
8723 1 075579 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75579ta.pdf
2004-05-28 00:00:00
8724 1 075580 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75580ltr.pdf
2000-10-18 00:00:00
8725 1 075580 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75580ta.pdf
2004-06-02 00:00:00
8726 1 075582 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75582ltr.pdf
2001-02-23 00:00:00
8727 1 075583 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75583ta.pdf
2004-06-03 00:00:00
8728 1 075588 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75588TA.pdf
2004-06-07 00:00:00
8729 1 075590 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75590TA.pdf
2004-06-09 00:00:00
8730 1 075591 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75591ltr.pdf
2001-05-10 00:00:00
8731 1 075593 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75593ltr.pdf
2004-06-15 00:00:00
8732 1 075597 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75597ltr.pdf
1999-12-23 00:00:00
8733 1 075598 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75598ta.pdf
2004-06-09 00:00:00
8734 1 075598 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75598ltr.pdf
2001-06-13 00:00:00
8735 1 075606 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75606ltr.pdf
2000-08-23 00:00:00
8736 1 075607 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75607ltr.pdf
2001-05-10 00:00:00
8737 1 075609 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75609ltr.pdf
2000-10-18 00:00:00
8738 1 075611 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75611_Famotidine_Appro
v.pdf 2003-12-24 00:00:00
8739 1 075613 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75613ltr.pdf
2000-10-10 00:00:00
8740 1 075619 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75619ta.pdf
2004-06-09 00:00:00
8741 1 075622 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75622ltr.pdf
2001-04-16 00:00:00
8742 1 075624 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75624ta.pdf
2004-06-03 00:00:00
8743 1 075624 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75624.ap.pdf
2001-09-18 00:00:00
8744 1 075629 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75629ltr.pdf
2000-05-09 00:00:00
8745 1 075630 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75630ltr.pdf
2001-04-12 00:00:00
8746 1 075635 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75635.ap..pdf
2003-04-14 00:00:00
8747 1 075637 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75637ltr.pdf
2000-10-31 00:00:00
8748 1 075640 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75640ltr.pdf
2000-01-28 00:00:00
8749 1 075647 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75647ltr.pdf
2001-02-05 00:00:00
8750 1 075650 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75650ta.pdf
2004-06-04 00:00:00
8751 1 075650 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75650d2.apf.pdf
2003-04-14 00:00:00
8752 1 075651 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75651ltr.pdf
2001-04-16 00:00:00
8753 1 075659 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75659TA.pdf
2003-04-14 00:00:00
8754 1 075664 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf
2003-04-14 00:00:00
8755 1 075665 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf
2001-02-05 00:00:00
8756 1 075667 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75667ltr.pdf
2000-07-28 00:00:00
8757 1 075669 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75669TA.pdf
2004-06-04 00:00:00
8758 1 075669 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75669ltr.pdf
2001-04-16 00:00:00
8759 1 075671 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol
%20Acetate.pdf 2001-07-25 00:00:00
8760 1 075672 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75672ltr.pdf
2000-09-25 00:00:00
8761 1 075678 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75678ltr.pdf
2000-07-26 00:00:00
8762 1 075679 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75679.ap.pdf
2003-04-10 00:00:00
8763 1 075682 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75682ltr.pdf
2003-04-14 00:00:00
8764 1 075685 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75685ta.pdf
2004-06-24 00:00:00
8765 1 075687 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75687ltr.pdf
2000-10-24 00:00:00
8766 1 075690 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75690TA.pdf
2004-06-04 00:00:00
8767 1 075696 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75696ltr.pdf
2000-07-31 00:00:00
8768 1 075698 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75698.ap.pdf
2003-04-14 00:00:00
8769 1 075703 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75703ltr.pdf
2000-11-27 00:00:00
8770 1 075705 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75705TA.pdf
2004-06-04 00:00:00
8771 1 075706 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75706_Loratadine
And Pseudoephedrine Sulfate_Approv.pdf 2003-12-24 00:00:00
8772 1 075707 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75707TA.pdf
2004-06-04 00:00:00
8773 1 075710 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075710s000ltr.pdf
2008-02-07 00:00:00
8774 1 075721 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75721ap.pdf
2003-04-14 00:00:00
8775 1 075725 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75725ltr.pdf
2000-12-19 00:00:00
8776 1 075726 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75726ltr.pdf
2001-03-30 00:00:00
8777 1 075727 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75727TA.pdf
2004-06-03 00:00:00
8778 1 075730 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75730ltr.pdf
2001-04-20 00:00:00
8779 1 075733 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75733_Clobetasol
Propionate_Approv.pdf 2003-12-24 00:00:00
8780 1 075734 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75734ltr.pdf
2000-08-29 00:00:00
8781 1 075737 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75737.AP.pdf
2003-04-10 00:00:00
8782 1 075742 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75742ltr.pdf
2000-11-29 00:00:00
8783 1 075743 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75743TA.pdf
2004-06-24 00:00:00
8784 1 075749 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75749.apd.pdf
2003-04-15 00:00:00
8785 1 075751 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75751ltr.pdf
2001-03-12 00:00:00
8786 1 075764 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75764ltr.pdf
2001-06-05 00:00:00
8787 1 075782 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75782ltr.pdf
2000-12-22 00:00:00
8788 1 075786 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75786ltr.pdf
2001-04-16 00:00:00
8789 1 075788 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75788ltr.pdf
2004-06-24 00:00:00
8790 1 075788 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75788TA.pdf
2004-06-03 00:00:00
8791 1 075793 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75793ltr.pdf
2001-04-16 00:00:00
8792 1 075794 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75794apdF.pdf
2003-04-15 00:00:00
8793 1 075796 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75796ltr.pdf
2004-05-27 00:00:00
8794 1 075797 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75797TA.pdf
2004-06-18 00:00:00
8795 1 075803 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75803.ap.pdf
2003-04-10 00:00:00
8796 1 075817 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75817.ta.pdf
2004-06-24 00:00:00
8797 1 075824 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75824AP.pdf
2003-04-10 00:00:00
8798 1 075825 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75825ltr.pdf
2001-04-17 00:00:00
8799 1 075825 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75825TA.pdf
2004-06-04 00:00:00
8800 1 075829 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75829.ap.pdf
2003-04-15 00:00:00
8801 1 075834 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75834_Milrinone
%20Lactate_Approv.pdf 2003-12-24 00:00:00
8802 1 075835 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75835.ap..pdf
2003-04-15 00:00:00
8803 1 075837 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75837ltr.pdf
2001-02-22 00:00:00
8804 1 075840 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75840.ap.pdf
2003-04-15 00:00:00
8805 1 075842 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75842ltr.pdf
2001-04-12 00:00:00
8806 1 075843 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75843.apdF.pdf
2003-04-15 00:00:00
8807 1 075845 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75845ltr.pdf
2001-01-31 00:00:00
8808 1 075847 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75847ltr.pdf
2001-02-28 00:00:00
8809 1 075851 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75851ltr.pdf
2003-04-15 00:00:00
8810 1 075852 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75852_Milrinone
%20Lactate_Approv.pdf 2003-12-24 00:00:00
8811 1 075855 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75855ltr.pdf
2001-01-31 00:00:00
8812 1 075858 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75858ltr.pdf
2001-06-18 00:00:00
8813 1 075860 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75860.ap.pdf
2003-04-10 00:00:00
8814 1 075868 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75868.ta.pdf
2003-04-10 00:00:00
8815 1 075869 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75869TA.pdf
2004-06-08 00:00:00
8816 1 075870 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75870d.apF.pdf
2003-04-17 00:00:00
8817 1 075873 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75873.TA.pdf
2003-04-10 00:00:00
8818 1 075875 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75875ltr.pdf
2000-12-21 00:00:00
8819 1 075888 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75888ltr.pdf
2000-11-29 00:00:00
8820 1 075894 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75894ltr.pdf
2001-04-18 00:00:00
8821 1 075897 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75897ltr.pdf
2001-01-25 00:00:00
8822 1 075898 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75898ltr.pdf
2001-03-12 00:00:00
8823 1 075899 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75899ltr.pdf
2001-01-17 00:00:00
8824 1 075901 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75901ltr.pdf
2000-12-28 00:00:00
8825 1 075902 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75902ltr.pdf
2001-05-07 00:00:00
8826 1 075905 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75905d.apF.pdf
2003-04-17 00:00:00
8827 1 075906 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75906ltr.pdf
2001-04-25 00:00:00
8828 1 075909 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75909ltr.pdf
2003-04-17 00:00:00
8829 1 075911 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75911APD.pdf
2003-04-10 00:00:00
8830 1 075913 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75913ltr.pdf
2004-03-24 00:00:00
8831 1 075915 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75915.ap.pdf
2003-04-16 00:00:00
8833 1 075926 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75926ltr.pdf
2004-06-24 00:00:00
8834 1 075928 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75928ltr.pdf
2004-06-10 00:00:00
8835 1 075932 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75932TAF.pdf
2003-04-10 00:00:00
8836 1 075932 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf
2004-03-24 00:00:00
8837 1 075934 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75934d.taF.pdf
2004-06-24 00:00:00
8838 1 075936 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75936taf.pdf
2003-04-16 00:00:00
8839 1 075939 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75939ltr.pdf
2004-06-15 00:00:00
8840 1 075940 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75940.ap.pdf
2003-04-16 00:00:00
8841 1 075944 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75944ta2.pdf
2004-06-24 00:00:00
8842 1 075950 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75950.ap.pdf
2003-04-16 00:00:00
8843 1 075968 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75968ltr.pdf
2002-06-25 00:00:00
8844 1 075983 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75983ltr.pdf
2002-06-25 00:00:00
8845 1 075998 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75998APltrF.pdf
2003-04-10 00:00:00
8846 1 075999 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75999ltr.pdf
2003-04-16 00:00:00
8847 1 076003 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76003ltr.pdf
2002-06-20 00:00:00
8848 1 076007 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76007ltr.pdf
2003-04-10 00:00:00
8849 1 076017 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76017ltr.pdf
2004-04-29 00:00:00
8850 1 076030 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76030ta.pdf
2003-04-16 00:00:00
8851 1 076032 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76032ltr.pdf
2001-05-09 00:00:00
8852 1 076035 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76035.ap.pdf
2003-04-16 00:00:00
8853 1 076042 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76042ltr.pdf
2004-07-30 00:00:00
8854 1 076044 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76044.ap.pdf
2003-04-10 00:00:00
8855 1 076045 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76045.ap.pdf
2003-04-15 00:00:00
8856 1 076057 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76057.apdf.pdf
2003-04-16 00:00:00
8857 1 076058 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76058.TA.pdf
2003-04-16 00:00:00
8858 1 076059 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76059ltr.pdf
2003-04-10 00:00:00
8859 1 076067 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ap.pdf
2003-04-10 00:00:00
8860 1 076067 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ta.pdf
2003-04-10 00:00:00
8861 1 076071 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76071ta2.pdf
2004-06-24 00:00:00
8862 1 076087 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76087ltr.pdf
2004-07-30 00:00:00
8863 1 076092 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76092.apdf.pdf
2003-04-16 00:00:00
8864 1 076100 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76100ltr.pdf
2002-06-20 00:00:00
8865 1 076104 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76104ltr.pdf
2004-06-01 00:00:00
8866 1 076109 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076109s000ltr.pdf
2009-11-09 00:00:00
8867 1 076114 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76114ltr.pdf
2003-04-10 00:00:00
8868 1 076117 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76117ltr.pdf
2003-04-16 00:00:00
8869 1 076141 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76141.ap.pdf
2003-04-10 00:00:00
8870 1 076145 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76145ltr.pdf
2004-07-30 00:00:00
8871 1 076154 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76154.ta.pdf
2003-04-11 00:00:00
8872 1 076178 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76178f.ta.pdf
2003-04-11 00:00:00
8874 1 076183 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076183s000ltr.pdf
2007-01-08 00:00:00
8875 1 076187 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/076187ltr.pdf
2004-02-18 00:00:00
8876 1 076200 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76200.apd.pdf
2002-03-19 00:00:00
8877 1 076203 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76203ltr.pdf
2004-04-07 00:00:00
8878 1 076211 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76211ltr.pdf
2004-02-12 00:00:00
8879 1 076231 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76231ltr.pdf
2004-05-26 00:00:00
8880 1 076236 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076236ltr.pdf
2005-04-19 00:00:00
8881 1 076246 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76246ltr.pdf
2004-07-30 00:00:00
8882 1 076264 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76264.APD.pdf
2003-04-11 00:00:00
8883 1 076267 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76267ltr.pdf
2004-02-12 00:00:00
8884 1 076269 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76269ltr.pdf
2004-06-21 00:00:00
8885 1 076274 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076274Orig1s000ltr.pdf
2012-05-18 00:00:00
8886 1 076285 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076285s000LTR.pdf
2006-06-27 00:00:00
8887 1 076287 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076287s000ltr.pdf
2008-05-28 00:00:00
8888 1 076300 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76300ltr.pdf
2004-05-26 00:00:00
8889 1 076304 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76304ltr.pdf
2004-07-30 00:00:00
8890 1 076310 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076310.pdf
2006-01-06 00:00:00
8891 1 076314 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf
2006-09-15 00:00:00
8892 1 076314 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf
2007-07-30 00:00:00
8893 1 076323 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76323ltr.pdf
2004-08-11 00:00:00
8894 1 076332 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76332ltr.pdf
2004-07-30 00:00:00
8895 1 076342 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76342ltr.pdf
2004-02-12 00:00:00
8896 1 076344 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76344ltr.pdf
2004-02-12 00:00:00
8897 1 076345 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76345ltr.pdf
2004-02-27 00:00:00
8898 1 076348 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76348ltr.pdf
2004-02-12 00:00:00
8899 1 076351 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76351ltr.pdf
2004-07-30 00:00:00
8900 1 076359 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76359ltr.pdf
2004-01-22 00:00:00
8901 1 076364 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76364ltr.pdf
2004-01-15 00:00:00
8902 1 076373 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076373s000_ltr.pdf
2007-09-07 00:00:00
8903 1 076386 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76386ltr.pdf
2004-07-30 00:00:00
8904 1 076387 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76387ltr.pdf
2004-07-30 00:00:00
8905 1 076404 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76404ltr.pdf
2004-06-16 00:00:00
8906 1 076408 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76408ltr.pdf
2004-06-01 00:00:00
8907 1 076410 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076410s000ltr.pdf
2007-05-01 00:00:00
8908 1 076413 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76413ltr.pdf
2004-06-21 00:00:00
8909 1 076417 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076417ltr.pdf
2005-04-28 00:00:00
8910 1 076422 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76422ltr.pdf
2004-08-06 00:00:00
8911 1 076424 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76424ltr.pdf
2004-07-30 00:00:00
8912 1 076430 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76430ltr.pdf
2004-02-27 00:00:00
8913 1 076447 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076447s007ltr.pdf
2008-01-09 00:00:00
8914 1 076448 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076448s000ltr.pdf
2009-04-21 00:00:00
8915 1 076451 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76451ltr.pdf
2004-05-26 00:00:00
8916 1 076470 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076470ltr.pdf
2005-07-08 00:00:00
8917 1 076476 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76476ltr.pdf
2004-02-12 00:00:00
8918 1 076484 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076484s000ltr.pdf
2006-09-18 00:00:00
8919 1 076504 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76504ltr.pdf
2006-03-01 00:00:00
8920 1 076507 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76507ltr.pdf
2004-07-30 00:00:00
8921 1 076517 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76517ltr.pdf
2004-10-18 00:00:00
8922 1 076534 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076534s000ltr.pdf
2011-10-31 00:00:00
8923 1 076553 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76553ltr.pdf
2004-07-30 00:00:00
8924 1 076554 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076554s000ltr.pdf
2009-08-14 00:00:00
8925 1 076558 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76558ltr.pdf
2004-06-15 00:00:00
8926 1 076563 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76563ltr.pdf
2006-09-15 00:00:00
8927 1 076578 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076578s000ltr.pdf
2007-05-01 00:00:00
8928 1 076583 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076583s000ltr.pdf
2009-11-10 00:00:00
8929 1 076593 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76593ltr.pdf
2004-06-15 00:00:00
8930 1 076607 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076607ltr.pdf
2004-12-30 00:00:00
8931 1 076610 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76610 AP_ltr.pdf
2006-03-23 00:00:00
8932 1 076611 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076611ltr.pdf
2006-04-13 00:00:00
8933 1 076615 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76615ltr.pdf
2004-05-26 00:00:00
8934 1 076617 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76617ltr.pdf
2004-07-30 00:00:00
8935 1 076622 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76622ltr.pdf
2004-05-26 00:00:00
8936 1 076631 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76631ltr.pdf
2004-02-12 00:00:00
8937 1 076633 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76633ltr.pdf
2004-05-26 00:00:00
8938 1 076636 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76636ltr.pdf
2004-02-12 00:00:00
8939 1 076642 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642
s005ltr.pdf 2007-10-22 00:00:00
8940 1 076642 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642
s005ltr.pdf 2007-10-22 00:00:00
8941 1 076643 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076643ltr.pdf
2005-06-14 00:00:00
8942 1 076648 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76648ltr.pdf
2004-03-24 00:00:00
8943 1 076653 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76653ltr.pdf
2004-07-30 00:00:00
8944 1 076658 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76658ltr.pdf
2004-07-30 00:00:00
8945 1 076668 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76668ltr.pdf
2004-05-26 00:00:00
8946 1 076677 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076677ltr.pdf
2008-01-09 00:00:00
8947 1 076679 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076679ltr.pdf
2004-12-30 00:00:00
8948 1 076688 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76688ltr.pdf
2004-02-12 00:00:00
8949 1 076690 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076690s000LTR.pdf
2006-08-07 00:00:00
8950 1 076697 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076697Orig1s000ltr.pdf
2011-05-24 00:00:00
8951 1 076699 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76699ltr.pdf
2004-08-31 00:00:00
8952 1 076703 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076703ltr.pdf
2005-01-27 00:00:00
8953 1 076730 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76730ltr.pdf
2004-07-30 00:00:00
8954 1 076745 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076745s000LTR.pdf
2006-11-14 00:00:00
8955 1 076747 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076747Orig1s000ltr.pdf
2013-01-30 00:00:00
8956 1 076764 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76764ltr.pdf
2004-06-24 00:00:00
8957 1 076765 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076765LTR.pdf
2006-05-25 00:00:00
8958 1 076765 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076765Orig1s000ltr.pdf
2012-03-16 00:00:00
8959 1 076770 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76770ltr.pdf
2004-04-29 00:00:00
8960 1 076786 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076786s000ltr.pdf
2010-12-01 00:00:00
8961 1 076791 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076791s004,076828s003l
tr.pdf 2008-01-09 00:00:00
8962 1 076792 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76792ltr.pdf
2004-08-25 00:00:00
8963 1 076793 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76793ltr.pdf
2004-05-26 00:00:00
8964 1 076794 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76794ltr.pdf
2004-06-15 00:00:00
8965 1 076798 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076798Orig1s000TAltr.p
df 2012-08-23 00:00:00
8966 1 076801 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076801Orig1s000ltr.pdf
2012-08-21 00:00:00
8967 1 076802 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076802ltr.pdf
2005-10-11 00:00:00
8968 1 076828 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076791s004,076828s003l
tr.pdf 2008-01-09 00:00:00
8969 1 076840 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076840s000ltr.pdf
2009-02-13 00:00:00
8970 1 076844 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076844ltr.pdf
2005-09-22 00:00:00
8971 1 076863 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76863ltr.pdf
2004-10-18 00:00:00
8972 1 076870 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76870ltr.pdf
2004-08-31 00:00:00
8973 1 076871 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076871revltr.pdf
2006-04-13 00:00:00
8974 1 076872 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076872ltr.pdf
2004-12-30 00:00:00
8975 1 076875 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076875ltr.pdf
2005-10-11 00:00:00
8976 1 076876 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076876s000ltr.pdf
2006-12-01 00:00:00
8977 1 076898 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/076898Orig1s000ltr.pdf
2014-06-02 00:00:00
8978 1 076903 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076903ltr.pdf
2004-12-30 00:00:00
8979 1 076910 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076910ltr.pdf
2005-04-28 00:00:00
8980 1 076932 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076932s000ltr.pdf
2009-07-09 00:00:00
8981 1 076933 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076933TA_ltr.pdf
2005-08-03 00:00:00
8982 1 076938 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/076938Orig1s000ltr.pdf
2014-03-06 00:00:00
8983 1 076953 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076953s000ltr.pdf
2010-10-04 00:00:00
8984 1 076969 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076969s000LTR.pdf
2006-08-04 00:00:00
8985 1 076969 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076969s002,
s003ltr.pdf 2007-05-29 00:00:00
8986 1 076973 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076973ltr.pdf
2005-07-15 00:00:00
8987 1 076976 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076976s000ltr.pdf
2009-08-14 00:00:00
8988 1 076981 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076981s000TAltr.pdf
2006-06-06 00:00:00
8989 1 076992 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076992s000ltr.pdf
2006-09-18 00:00:00
8990 1 077001 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077001ltr.pdf
2004-12-30 00:00:00
8991 1 077018 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077018s000LTR.pdf
2006-06-14 00:00:00
8992 1 077021 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77021ltr.pdf
2004-12-02 00:00:00
8993 1 077022 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77022ltr.pdf
2004-12-02 00:00:00
8994 1 077031 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77031ltr.pdf
2004-10-29 00:00:00
8995 1 077033 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77033ltr.pdf
2004-10-29 00:00:00
8996 1 077035 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77035ltr.pdf
2004-10-29 00:00:00
8997 1 077038 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77038ltr.pdf
2004-10-29 00:00:00
8998 1 077056 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077056ltrTA.pdf
2006-04-25 00:00:00
8999 1 077065 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077065s000_ltr.pdf
2007-07-05 00:00:00
9000 1 077067 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077067s000_LTR.pdf
2007-04-25 00:00:00
9001 1 077083 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077083ltr.pdf
2005-09-15 00:00:00
9002 1 077087 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077087ltr.pdf
2005-09-15 00:00:00
9003 1 077090 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077090ltr.pdf
2005-09-15 00:00:00
9004 1 077091 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077091ltr.pdf
2005-10-11 00:00:00
9005 1 077123 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077123ltr.pdf
2004-12-23 00:00:00
9006 1 077132 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077132s000ltr.pdf
2007-10-10 00:00:00
9007 1 077136 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077136s000_ltr.pdf
2007-07-05 00:00:00
9008 1 077137 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077137s000_ltr.pdf
2007-07-05 00:00:00
9009 1 077138 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077138s000ltr.pdf
2008-03-19 00:00:00
9010 1 077139 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077139Orig1s016ltr.pdf
2014-11-04 00:00:00
9011 1 077149 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077149ltr.pdf
2006-04-05 00:00:00
9012 1 077157 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077157s000ltr.pdf
2010-04-09 00:00:00
9013 1 077159 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077159s000ltr.pdf
2012-04-02 00:00:00
9014 1 077167 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77167ltr.pdf
2004-12-06 00:00:00
9015 1 077174 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077174ltr.pdf
2005-06-07 00:00:00
9016 1 077179 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077179s000ltr.pdf
2007-05-29 00:00:00
9017 1 077197 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077197LTR.pdf
2006-05-25 00:00:00
9018 1 077214 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077214s000ltr.pdf
2007-05-01 00:00:00
9019 1 077218 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077218ltr.pdf
2005-01-13 00:00:00
9020 1 077223 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077223s000_ltr.pdf
2007-07-05 00:00:00
9021 1 077233 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077233s000ltr.pdf
2006-09-25 00:00:00
9022 1 077236 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077236s000ltr.pdf
2007-03-15 00:00:00
9023 1 077238 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/77238s000ltr.pdf
2008-06-09 00:00:00
9024 1 077243 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077243s000TAltr.pdf
2006-11-14 00:00:00
9025 1 077245 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077245s000ltr.pdf
2006-09-18 00:00:00
9026 1 077264 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077264s000ltr.pdf
2006-11-06 00:00:00
9027 1 077268 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077268ltr.pdf
2005-09-22 00:00:00
9028 1 077269 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77269ltr.pdf
2004-10-18 00:00:00
9029 1 077274 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077274ltr.pdf
2005-10-10 00:00:00
9030 1 077277 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077277LTR.pdf
2006-05-03 00:00:00
9031 1 077287 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077287s000ltr.pdf
2006-09-20 00:00:00
9032 1 077297 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077297TA_ltr.pdf
2005-08-19 00:00:00
9033 1 077297 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297
Orig1s016,078392Orig1s017ltr.pdf 2014-09-24 00:00:00
9034 1 077308 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077308s000ltr.pdf
2009-11-10 00:00:00
9035 1 077309 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077309ltr.pdf
2005-10-20 00:00:00
9036 1 077327 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077327ltr.pdf
2005-09-22 00:00:00
9037 1 077337 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077337Orig1s000ltr.pdf
2014-05-09 00:00:00
9038 1 077356 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77356ltr.pdf
2006-04-12 00:00:00
9039 1 077369 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077369s000ltr.pdf
2012-04-02 00:00:00
9040 1 077406 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077406s000ltr.pdf
2007-01-08 00:00:00
9041 1 077411 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77411TAltr.pdf
2006-09-15 00:00:00
9042 1 077412 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077412s000TAltr.pdf
2011-05-10 00:00:00
9043 1 077421 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077421s000LTR.pdf
2006-07-13 00:00:00
9044 1 077428 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077428s000TAltr.pdf
2006-06-28 00:00:00
9045 1 077437 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077437Orig1s000ltr.pdf
2014-02-20 00:00:00
9046 1 077453 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077453s000ltr.pdf
2008-01-25 00:00:00
9047 1 077461 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077461s000ltr.pdf
2009-09-16 00:00:00
9048 1 077464 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077464TA_ltr.pdf
2005-06-15 00:00:00
9049 1 077464 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077464s000ltr.pdf
2007-10-04 00:00:00
9050 1 077467 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077467s000ltr.pdf
2009-09-16 00:00:00
9051 1 077474 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077474s000_ltr.pdf
2007-09-07 00:00:00
9052 1 077487 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000TAltr.pdf
2007-07-05 00:00:00
9053 1 077492 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077492Orig1s000ltr.pdf
2012-09-21 00:00:00
9054 1 077500 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077500s000_ltr.pdf
2006-09-15 00:00:00
9055 1 077507 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077507ltr.pdf
2005-11-01 00:00:00
9056 1 077524 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077524s000ltr.pdf
2008-04-15 00:00:00
9057 1 077550 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077550s000TAltr.pdf
2011-05-10 00:00:00
9058 1 077555 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077555s000ltr.pdf
2011-11-10 00:00:00
9059 1 077558 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077558TA.pdf
2005-07-15 00:00:00
9060 1 077561 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077561s000ltr.pdf
2012-03-06 00:00:00
9061 1 077562 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077562s000TAltr.pdf
2011-04-21 00:00:00
9062 1 077565 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077565s000TAltr.pdf
2011-04-21 00:00:00
9063 1 077571 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077571taltr.pdf
2007-08-14 00:00:00
9064 1 077571 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077571Orig1s000ltr.pdf
2013-07-12 00:00:00
9065 1 077603 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077603s000ltr.pdf
2008-08-29 00:00:00
9066 1 077615 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077615s000ltr.pdf
2008-08-05 00:00:00
9067 1 077631 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077631ltr.pdf
2008-01-18 00:00:00
9068 1 077635 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077635rev2.pdf
2006-01-18 00:00:00
9069 1 077637 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077637rev2.pdf
2005-12-28 00:00:00
9070 1 077641 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077641ltr.pdf
2005-12-28 00:00:00
9071 1 077642 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077642ltr.pdf
2005-12-28 00:00:00
9072 1 077645 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077645ltr.pdf
2005-12-28 00:00:00
9073 1 077647 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077647ltr.pdf
2005-12-28 00:00:00
9074 1 077665 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077665Orig1s000ltr.pdf
2012-05-18 00:00:00
9075 1 077673 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077673TA_ltr.pdf
2005-06-29 00:00:00
9076 1 077684 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077684s000ltr.pdf
2007-07-05 00:00:00
9077 1 077734 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077734s000TAltr.pdf
2011-05-10 00:00:00
9078 1 077753 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077753s000ltr.pdf
2008-03-19 00:00:00
9079 1 077763 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077763s000ltr.pdf
2008-03-11 00:00:00
9080 1 077764 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077764s000ltr.pdf
2009-03-17 00:00:00
9081 1 077773 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077773s000ltr.pdf
2007-05-01 00:00:00
9082 1 077774 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077774ta-ltr.pdf
2005-12-22 00:00:00
9083 1 077774 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077774s000ltr.pdf
2008-12-31 00:00:00
9084 1 077795 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077795s000ltr.pdf
2007-10-10 00:00:00
9085 1 077798 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077798s000TAltr.pdf
2011-05-10 00:00:00
9086 1 077802 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077802s000ltr.pdf
2007-10-10 00:00:00
9087 1 077833 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077833s000ltr.pdf
2007-04-09 00:00:00
9088 1 077841 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077841s000ltr.pdf
2007-08-14 00:00:00
9089 1 077844 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077844s000TAltr.pdf
2006-05-21 00:00:00
9090 1 077857 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077857s000ltr.pdf
2010-07-23 00:00:00
9091 1 077858 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077858s000ltr.pdf
2008-10-01 00:00:00
9092 1 077916 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077916TA-LTR.pdf
2006-05-26 00:00:00
9093 1 077919 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077919s000_ltr.pdf
2007-07-05 00:00:00
9094 1 077925 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77925ltr.pdf
2006-07-21 00:00:00
9095 1 077929 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77929ltr.pdf
2006-07-21 00:00:00
9096 1 077933 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77933ltr.pdf
2006-07-21 00:00:00
9097 1 077938 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077938ltr.pdf
2006-07-21 00:00:00
9098 1 077946 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077946ltr.pdf
2008-01-09 00:00:00
9099 1 077956 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077956s000TAltr.pdf
2006-05-21 00:00:00
9100 1 077960 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077960s000LTR.pdf
2006-10-18 00:00:00
9101 1 077963 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297
Orig1s016,078392Orig1s017ltr.pdf 2014-09-24 00:00:00
9102 1 077981 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077981s000ltr.pdf
2008-07-01 00:00:00
9103 1 077983 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077983s000ltr.pdf
2008-12-29 00:00:00
9104 1 077985 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077985s000ltr.pdf
2007-05-01 00:00:00
9105 1 077990 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077990s000ltr.pdf
2007-05-01 00:00:00
9106 1 077995 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077995s000ltr.pdf
2009-07-09 00:00:00
9107 1 078003 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078003Orig1s000ltr.pdf
2015-01-28 00:00:00
9108 1 078020 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078020Orig1s000ltr.pdf
2012-09-24 00:00:00
9109 1 078030 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078030s000ltr.pdf
2009-03-24 00:00:00
9110 1 078046 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078046ltr.pdf
2007-09-25 00:00:00
9111 1 078061 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078061Orig1s000ltr.pdf
2015-05-20 00:00:00
9112 1 078064 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/078064Orig1s000ltr.pdf
2006-12-28 00:00:00
9113 1 078065 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078065s000ltr.pdf
2007-01-31 00:00:00
9114 1 078079 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078079s000ltr.pdf
2007-09-25 00:00:00
9115 1 078088 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078088ltr.pdf
2009-01-12 00:00:00
9116 1 078095 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078095s000ltr.pdf
2008-06-10 00:00:00
9117 1 078104 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078104s000ltr.pdf
2009-08-06 00:00:00
9118 1 078112 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078112ltr.pdf
2007-03-15 00:00:00
9119 1 078114 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078114s000ltr.pdf
2008-03-19 00:00:00
9120 1 078115 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078115s000ltr.pdf
2009-04-03 00:00:00
9121 1 078128 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078128ltr.pdf
2006-04-05 00:00:00
9122 1 078134 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078134Orig1s000Approv.pdf
2012-02-14 00:00:00
9123 1 078137 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078137s000ltr.pdf
2007-08-07 00:00:00
9124 1 078144 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078144s000ltr.pdf
2007-09-25 00:00:00
9125 1 078158 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078158s000ltr.pdf
2007-08-07 00:00:00
9126 1 078163 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078163s000_ltr.pdf
2007-07-05 00:00:00
9127 1 078165 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078165s000_ltr.pdf
2007-09-07 00:00:00
9128 1 078172 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078172ltr.pdf
2007-09-25 00:00:00
9129 1 078193 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078193Orig1s000ltr.pdf
2014-03-06 00:00:00
9130 1 078199 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078199s000_ltr.pdf
2007-07-05 00:00:00
9131 1 078217 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078217s000_ltr.pdf
2007-09-07 00:00:00
9132 1 078219 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078219s000TAltr.pdf
2011-05-10 00:00:00
9133 1 078223 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078223s000ltr.pdf
2008-12-11 00:00:00
9134 1 078233 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078233s000ltr.pdf
2007-09-25 00:00:00
9135 1 078242 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078242ltr.pdf
2008-01-30 00:00:00
9136 1 078270 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078270s000ltr.pdf
2007-09-25 00:00:00
9137 1 078279 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078279Orig1s000ltr.pdf
2015-10-02 00:00:00
9138 1 078292 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078292s000ltr.pdf
2008-07-01 00:00:00
9139 1 078295 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078295s000ltr.pdf
2009-08-14 00:00:00
9140 1 078305 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078305s000ltr.pdf
2008-05-08 00:00:00
9141 1 078306 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078306ltr.pdf
2007-08-14 00:00:00
9142 1 078313 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078313s000TAltr.pdf
2011-05-10 00:00:00
9143 1 078327 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078327s000ltr.pdf
2009-08-14 00:00:00
9144 1 078332 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078332s000_ltr.pdf
2007-09-07 00:00:00
9145 1 078336 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078336ltr.pdf
2008-01-09 00:00:00
9146 1 078337 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078337Orig1s000ltr.pdf
2012-11-28 00:00:00
9147 1 078348 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078348s000ltr.pdf
2011-02-18 00:00:00
9148 1 078349 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078349s000ltr.pdf
2007-05-29 00:00:00
9149 1 078366 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078366s000ltr.pdf
2011-04-28 00:00:00
9150 1 078368 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078368s000ltr.pdf
2008-01-09 00:00:00
9151 1 078378 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078378s000LTR.pdf
2007-07-27 00:00:00
9152 1 078380 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/78380TA_ltr.pdf
2007-08-14 00:00:00
9153 1 078384 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078384s000_ltr.pdf
2007-09-07 00:00:00
9154 1 078396 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078396s000ltr.pdf
2008-04-28 00:00:00
9155 1 078458 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078458Orig1s010ltr.pdf
2016-06-24 00:00:00
9156 1 078462 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078462s000ltr.pdf
2009-04-01 00:00:00
9157 1 078467 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078467s000TAltr.pdf
2011-05-10 00:00:00
9158 1 078470 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078470s000ltr.pdf
2008-05-09 00:00:00
9159 1 078482 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078482s000ltr.pdf
2008-08-05 00:00:00
9160 1 078485 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078485s000ltr.pdf
2010-06-30 00:00:00
9161 1 078515 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078515s000ltr.pdf
2009-04-03 00:00:00
9162 1 078522 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090
Orig1s005,078522Orig1s005ltr.pdf 2014-09-24 00:00:00
9163 1 078540 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078540s000ltr.pdf
2010-10-20 00:00:00
9165 1 078562 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078562s000ltr.pdf
2009-05-06 00:00:00
9166 1 078575 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078575s000ltr.pdf
2009-07-09 00:00:00
9167 1 078577 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078577Orig1s000ltr.pdf
2015-08-13 00:00:00
9168 1 078580 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078580Orig1s000ltr.pdf
2013-03-04 00:00:00
9169 1 078582 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078582s000ltr.pdf
2009-01-21 00:00:00
9170 1 078584 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078584taltr.pdf
2007-08-14 00:00:00
9171 1 078597 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078597s000ltr.pdf
2008-08-05 00:00:00
9172 1 078604 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078604s000TAltr.pdf
2011-05-10 00:00:00
9173 1 078605 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078605Orig1s000ltr.pdf
2012-08-06 00:00:00
9174 1 078625 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078625Orig1s000Approv.pdf
2012-02-14 00:00:00
9175 1 078669 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078669Orig1s000Approv.pdf
2012-02-14 00:00:00
9176 1 078706 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078706s000ltr.pdf
2008-06-10 00:00:00
9177 1 078713 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078713s000ltr.pdf
2008-07-18 00:00:00
9178 1 078721 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078721s000ltr.pdf
2009-11-10 00:00:00
9179 1 078734 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078734s000ltr.pdf
2009-06-30 00:00:00
9180 1 078742 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078742s000TAltr.pdf
2007-04-20 00:00:00
9181 1 078775 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078775s000TAltr.pdf
2007-05-01 00:00:00
9182 1 078780 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078780s000ltr.pdf
2010-01-26 00:00:00
9183 1 078783 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000(2)ltr.pdf
2009-11-19 00:00:00
9184 1 078783 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000ltr.pdf
2009-07-15 00:00:00
9185 1 078785 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078785s_TAltr.pdf
2008-02-07 00:00:00
9186 1 078790 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078790s000ltr.pdf
2008-08-05 00:00:00
9187 1 078800 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078800s000TAltr.pdf
2009-05-06 00:00:00
9188 1 078829 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078829s000ltr.pdf
2008-06-10 00:00:00
9189 1 078830 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078830Orig1s000ltr.pdf
2015-02-26 00:00:00
9190 1 078834 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078834s000ltr.pdf
2011-06-02 00:00:00
9191 1 078850 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078850TAltr.pdf
2008-01-30 00:00:00
9192 1 078868 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078868s000ltr.pdf
2012-02-10 00:00:00
9193 1 078887 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078887s000TAltr.pdf
2007-10-04 00:00:00
9194 1 078901 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078901Orig1s000ltr.pdf
2012-12-18 00:00:00
9195 1 078915 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078915s000ltr.pdf
2009-10-14 00:00:00
9196 1 078917 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078917s000ltr.pdf
2009-07-09 00:00:00
9197 1 078921 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078921s000ltr.pdf
2010-06-30 00:00:00
9198 1 078922 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078922s000ltr.pdf
2008-02-19 00:00:00
9199 1 078929 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/78929TA_ltr.pdf
2007-08-14 00:00:00
9200 1 078936 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000ltr.pdf
2015-08-06 00:00:00
9201 1 078936 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000TAltr.p
df 2015-02-06 00:00:00
9202 1 078944 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078944s000ltr.pdf
2010-06-30 00:00:00
9203 1 078957 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078957s000_TA_PEPFAR_L
tr.pdf 2008-03-04 00:00:00
9204 1 078957 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078957s000ltr.pdf
2008-12-31 00:00:00
9205 1 078964 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078964Orig1s000ltr.pdf
2013-11-12 00:00:00
9206 1 078965 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078965s000ltr.pdf
2010-08-10 00:00:00
9207 1 078966 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078966s000ltr.pdf
2010-05-27 00:00:00
9208 1 078974 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078974s000ltr.pdf
2011-02-24 00:00:00
9209 1 078976 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078976s000ltr.pdf
2009-01-21 00:00:00
9210 1 078989 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078989s000ltr.pdf
2008-06-10 00:00:00
9211 1 078992 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078992Orig1s000ltr.pdf
2013-12-05 00:00:00
9212 1 079043 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079043s003ltr.pdf
2011-06-29 00:00:00
9213 1 079054 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079054s000ltr.pdf
2015-11-06 00:00:00
9214 1 079057 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079057s000ltr.pdf
2011-07-20 00:00:00
9215 1 079063 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079063s000ltr.pdf
2009-01-21 00:00:00
9216 1 079070 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079070s000ltr.pdf
2009-11-13 00:00:00
9217 1 079071 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/079071s000TAltr.pdf
2008-01-09 00:00:00
9218 1 079074 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079074s000ltr.pdf
2009-03-13 00:00:00
9219 1 079075 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079075s000ltr.pdf
2011-01-14 00:00:00
9220 1 079086 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079086s000ltr.pdf
2011-03-02 00:00:00
9221 1 079089 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079089s000ltr.pdf
2009-07-09 00:00:00
9222 1 079099 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/079099Orig1s000Approv.pdf
2012-02-14 00:00:00
9223 1 079103 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/079103Orig1s000ltr.pdf
2012-08-06 00:00:00
9224 1 079135 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079135s003ltr.pdf
2010-10-29 00:00:00
9225 1 079138 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079138s000ltr.pdf
2010-06-24 00:00:00
9226 1 079145 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079145Orig1s000ltr.pdf
2016-07-20 00:00:00
9227 1 079153 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079153s000ltr.pdf
2009-04-01 00:00:00
9228 1 079161 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079161s000ltr.pdf
2010-05-17 00:00:00
9229 1 079162 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079162s000ltr.pdf
2009-04-03 00:00:00
9230 1 079166 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079166s000ltr.pdf
2010-05-17 00:00:00
9231 1 079169 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079169Orig1s000ltr.pdf
2016-07-20 00:00:00
9232 1 079170 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079170Orig1s000ltr.pdf
2016-07-20 00:00:00
9233 1 079171 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079171Orig1s000ltr.pdf
2016-07-20 00:00:00
9234 1 079191 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079191s000ltr.pdf
2010-04-19 00:00:00
9235 1 079194 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079194s000ltr.pdf
2009-04-09 00:00:00
9236 1 079199 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079199s000ltr.pdf
2008-12-02 00:00:00
9237 1 079220 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079220s000ltr.pdf
2010-06-30 00:00:00
9238 1 079235 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079235s000ltr.pdf
2010-10-04 00:00:00
9239 1 084349 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072lt
r.pdf 2014-03-06 00:00:00
9240 1 084349 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084349Orig1s070ltr.pdf
2013-08-08 00:00:00
9241 1 084349 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072lt
r.pdf 2014-03-06 00:00:00
9242 1 084427 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084427Orig1s032ltr.pdf
2015-04-23 00:00:00
9243 1 084916 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572
Orig1s002,084916Orig1s066ltr.pdf 2015-07-28 00:00:00
9244 1 087329 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s019ltr.pdf
2014-06-11 00:00:00
9245 1 087329 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s020ltr.pdf
2014-10-21 00:00:00
9247 1 087846 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/087844Orig1s025,087845
Orig1s025,087846Orig1s026ltr.pdf 2013-03-13 00:00:00
9248 1 089699 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040432s006,040556s012,
040658s006,040846s005,089699s044ltr.pdf 2015-10-22 00:00:00
9249 1 089885 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf
1998-10-30 00:00:00
9250 1 090024 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090024s000ltr.pdf
2009-02-04 00:00:00
9251 1 090033 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090033Orig1s000ltr.pdf
2014-02-26 00:00:00
9252 1 090044 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090044Orig1s000ltr.pdf
2016-02-18 00:00:00
9253 1 090049 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090049s000ltr.pdf
2009-04-03 00:00:00
9254 1 090072 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090072s000ltr.pdf
2009-11-13 00:00:00
9255 1 090088 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090088s000ltr.pdf
2010-07-02 00:00:00
9256 1 090092 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090092s000ltr.pdf
2008-04-28 00:00:00
9257 1 090120 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf
2012-03-28 00:00:00
9258 1 090120 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090120s000ltr.pdf
2012-03-30 00:00:00
9259 1 090155 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090155s000ltr.pdf
2009-08-06 00:00:00
9260 1 090164 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090164s000ltr.pdf
2009-06-02 00:00:00
9261 1 090180 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090180s000ltr.pdf
2010-03-22 00:00:00
9262 1 090193 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090193s000ltr.pdf
2008-11-28 00:00:00
9263 1 090227 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090227s000ltr.pdf
2010-04-23 00:00:00
9264 1 090288 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090288s000ltr.pdf
2010-07-09 00:00:00
9265 1 090308 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090308Orig1s000TAltr.p
df 2015-11-30 00:00:00
9266 1 090309 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090309s000ltr.pdf
2009-07-20 00:00:00
9267 1 090371 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090371s000ltr.pdf
2009-11-24 00:00:00
9268 1 090431 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s005ltr.pdf
2016-05-04 00:00:00
9269 1 090494 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090494Orig1s000ltr.pdf
2012-05-18 00:00:00
9270 1 090505 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090505s000ltr.pdf
2011-04-11 00:00:00
9271 1 090513 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090513s000ltr.pdf
2009-04-03 00:00:00
9272 1 090526 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090526Orig1s000ltr.pdf
2014-03-06 00:00:00
9273 1 090528 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090528s000ltr.pdf
2010-04-09 00:00:00
9274 1 090540 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090540Orig1s000ltr.pdf
2012-05-18 00:00:00
9275 1 090547 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090547s000ltr.pdf
2010-04-28 00:00:00
9276 1 090561 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090561s000ltr.pdf
2010-11-03 00:00:00
9277 1 090568 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090568s000ltr.pdf
2010-06-30 00:00:00
9278 1 090574 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090574s000ltr.pdf
2009-12-24 00:00:00
9279 1 090576 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090576s000ltr.pdf
2009-11-20 00:00:00
9280 1 090607 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090607Orig1s000Approv.pdf
2012-02-14 00:00:00
9281 1 090625 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090625Orig1s000ltr.pdf
2012-05-18 00:00:00
9282 1 090636 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090636s000ltr.pdf
2010-04-05 00:00:00
9283 1 090647 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090647s000ltr.pdf
2009-02-23 00:00:00
9284 1 090659 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090659s000ltr.pdf
2009-04-20 00:00:00
9285 1 090678 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090678Orig1s000ltr.pdf
2013-11-12 00:00:00
9286 1 090713 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090713Orig1s000ltr.pdf
2018-04-05 00:00:00
9287 1 090723 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090723Orig1s000ltr.pdf
2013-12-13 00:00:00
9288 1 090728 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090728Orig1s000ltr.pdf
2014-01-10 00:00:00
9289 1 090739 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090739Orig1s000ltr.pdf
2014-01-10 00:00:00
9290 1 090745 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090745Orig1s000ltr.pdf
2013-12-13 00:00:00
9291 1 090749 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090749s000ltr.pdf
2012-03-29 00:00:00
9292 1 090774 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090774Orig1s000ltr.pdf
2013-12-13 00:00:00
9293 1 090778 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090778Orig1s000ltr.pdf
2013-12-13 00:00:00
9294 1 090780 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090780Orig1s000ltr.pdf
2015-10-30 00:00:00
9295 1 090785 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090785s000ltr.pdf
2010-04-05 00:00:00
9296 1 090788 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090788s000ltr.pdf
2010-04-13 00:00:00
9297 1 090813 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090813s000ltr.pdf
2010-06-02 00:00:00
9298 1 090829 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090829s000ltr.pdf
2010-08-26 00:00:00
9299 1 090833 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090833Orig1s000ltr.pdf
2012-12-18 00:00:00
9300 1 090853 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090853Orig1s000ltr.pdf
2014-02-19 00:00:00
9301 1 090856 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090856s000ltr.pdf
2011-12-29 00:00:00
9302 1 090870 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090870s000ltr.pdf
2011-11-21 00:00:00
9303 1 090874 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090874s000ltr.pdf
2010-07-27 00:00:00
9304 1 090895 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090895s000ltr.pdf
2009-09-01 00:00:00
9305 1 090910 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090910s000ltr.pdf
2011-11-28 00:00:00
9306 1 090926 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090926Orig1s000ltr.pdf
2012-08-06 00:00:00
9307 1 090955 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090955Orig1s000ltr.pdf
2012-08-06 00:00:00
9308 1 090962 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090962s000ltr.pdf
2010-06-08 00:00:00
9309 1 091001 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091001s000ltr.pdf
2011-02-03 00:00:00
9310 1 091007 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091007s000ltr.pdf
2011-11-21 00:00:00
9311 1 091011 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091011Orig1s000ltr.pdf
2015-06-12 00:00:00
9312 1 091020 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091020s000ltr.pdf
2010-06-02 00:00:00
9313 1 091051 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091051s000ltr.pdf
2010-07-02 00:00:00
9314 1 091052 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091052s000ltr.pdf
2011-09-28 00:00:00
9315 1 091055 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091055Orig1s000ltr.pdf
2013-08-05 00:00:00
9316 1 091070 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091070Orig1s000ltr.pdf
2015-09-04 00:00:00
9317 1 091077 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/091077s000ltr.pdf
2009-10-14 00:00:00
9318 1 091108 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091108s000ltr.pdf
2011-07-29 00:00:00
9319 1 091128 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091128Orig1s000ltr.pdf
2012-08-06 00:00:00
9320 1 091135 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091135Orig1s000ltr.pdf
2012-05-30 00:00:00
9321 1 091144 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091144s000ltr.pdf
2012-02-02 00:00:00
9322 1 091154 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091154Orig1s000TAltr.p
df 2015-10-21 00:00:00
9323 1 091169 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091169s000ltr.pdf
2011-05-25 00:00:00
9324 1 091210 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091210Orig1s000ltr.pdf
2016-02-09 00:00:00
9325 1 091216 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091216Orig1s000ltr.pdf
2012-05-18 00:00:00
9326 1 091248 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091248Orig1s000ltr.pdf
2014-01-14 00:00:00
9327 1 091260 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091260s000ltr.pdf
2011-08-26 00:00:00
9328 1 091261 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091261s000ltr.pdf
2011-09-28 00:00:00
9329 1 091263 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091263s000ltr.pdf
2011-11-08 00:00:00
9330 1 091285 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091285Orig1s000Approv.
pdf 2011-09-12 00:00:00
9331 1 091289 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091289Orig1s000ltr.pdf
2012-10-15 00:00:00
9332 1 091326 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091326s000ltr.pdf
2010-07-12 00:00:00
9333 1 091344 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091344s000ltr.pdf
2011-05-03 00:00:00
9334 1 091379 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091379Orig1s000ltr.pdf
2012-11-07 00:00:00
9335 1 091387 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091387s000ltr.pdf
2010-02-17 00:00:00
9336 1 091388 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091388s000ltr.pdf
2012-03-30 00:00:00
9337 1 091422 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091422Orig1s000ltr.pdf
2013-02-26 00:00:00
9338 1 091422 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091422Orig1s006ltr.pdf
2014-05-29 00:00:00
9339 1 091433 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091433s000ltr.pdf
2011-11-07 00:00:00
9340 1 091476 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091476Orig1s000ltr.pdf
2013-03-15 00:00:00
9341 1 091516 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091516Orig1s000ltr.pdf
2015-04-27 00:00:00
9342 1 091560 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091560s000ltr.pdf
2010-10-04 00:00:00
9343 1 091575 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091575s000ltr.pdf
2010-08-31 00:00:00
9344 1 091588 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091588Orig1s000ltr.pdf
2012-08-06 00:00:00
9345 1 091601 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091601s000ltr.pdf
2010-07-28 00:00:00
9346 1 091611 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091611s000ltr.pdf
2010-09-20 00:00:00
9347 1 091612 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091612Orig1s000ltr.pdf
2015-03-20 00:00:00
9348 1 091648 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091648Orig1s000ltr.pdf
2014-02-27 00:00:00
9349 1 091649 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091649Orig1s000ltr.pdf
2013-09-19 00:00:00
9350 1 091652 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091652s000ltr.pdf
2010-04-09 00:00:00
9351 1 091664 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091664Orig1s000ltr.pdf
2013-07-22 00:00:00
9352 1 101063 SUPPL 5012 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/aspamer080102L.pdf
2004-03-12 00:00:00
9353 1 101063 SUPPL 5036 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/101063_5036l
tr.pdf 2004-07-07 00:00:00
9354 1 101063 SUPPL 5071 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/101063 5071
Ltr.pdf 2006-07-25 00:00:00
9355 1 103000 SUPPL 5000 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/botuall041202L.htm
2004-03-11 00:00:00
9356 1 103000 SUPPL 5050 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103000_5050l
tr.pdf 2004-07-21 00:00:00
9357 1 103000 SUPPL 5209 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103000s5209s5210ltr.pd
f 2009-08-07 00:00:00
9358 1 103000 SUPPL 5215 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5215ltr.pdf
2010-10-20 00:00:00
9359 1 103000 SUPPL 5251 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103000Orig1s5251ltr.pd
f 2013-01-23 00:00:00
9360 1 103000 SUPPL 5253 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5253ltr.pd
f 2012-11-14 00:00:00
9361 1 103000 SUPPL 5256 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5256ltr.pd
f 2012-07-18 00:00:00
9362 1 103000 SUPPL 5292 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5292ltr.pd
f 2015-08-12 00:00:00
9363 1 103000 SUPPL 5294 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103000Orig1s5294ltr.pd
f 2016-02-05 00:00:00
9364 1 103132 SUPPL 1116 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ifnasch110697L.htm
2004-03-17 00:00:00
9365 1 103132 SUPPL 5059 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf
2007-05-29 00:00:00
9366 1 103132 SUPPL 5064 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103132_5064ltr.pdf
2005-01-26 00:00:00
9367 1 103132 SUPPL 5086 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103132s5086ltr.pdf
2006-10-13 00:00:00
9368 1 103132 SUPPL 5096 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5096ltr.pdf
2007-07-24 00:00:00
9369 1 103132 SUPPL 5108 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103132s5108ltr.pdf
2008-05-30 00:00:00
9370 1 103132 SUPPL 5143 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5143ltr.pdf
2011-02-15 00:00:00
9371 1 103132 SUPPL 5161 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5161ltr.pdf
2011-12-28 00:00:00
9372 1 103172 SUPPL 5009 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/altegen051502L.htm
2004-03-10 00:00:00
9373 1 103172 SUPPL 5203 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103172Orig1s5203ltr.pd
f 2015-02-17 00:00:00
9374 1 103234 SUPPL 5122 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103234s5122ltr.pdf
2007-03-15 00:00:00
9375 1 103234 SUPPL 5195 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.p
df 2011-04-28 00:00:00
9376 1 103234 SUPPL 5196 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.p
df 2011-04-28 00:00:00
9377 1 103234 SUPPL 5199 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103234s5199ltr.pdf
2010-02-16 00:00:00
9378 1 103234 SUPPL 5221 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103234s5221ltr.pdf
2010-02-05 00:00:00
9379 1 103293 SUPPL 1021 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/aldechi010998L.htm
2004-03-26 00:00:00
9380 1 103293 SUPPL 5114 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5114ltr.pdf
2011-08-02 00:00:00
9381 1 103293 SUPPL 5123 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5123ltr.pdf
2012-01-05 00:00:00
9382 1 103353 SUPPL 1036 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/filgamg040298L.htm
2004-03-25 00:00:00
9383 1 103353 SUPPL 5001 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/filgamg052902L.pdf
2004-03-25 00:00:00
9384 1 103353 SUPPL 5147 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103353s5147ltr.pdf
2012-05-29 00:00:00
9385 1 103353 SUPPL 5157 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103353Orig1s5157ltr.pd
f 2013-09-17 00:00:00
9386 1 103353 SUPPL 5184 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5184ltr.pd
f 2015-02-06 00:00:00
9387 1 103411 SUPPL 5180 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103411Orig1s5180ltr.pd
f 2014-04-23 00:00:00
9388 1 103471 SUPPL 1039 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbchi031403L.htm
2004-03-11 00:00:00
9389 1 103471 SUPPL 5032 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103471-
5032ltr.pdf 2003-10-31 00:00:00
9390 1 103471 SUPPL 5067 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,
s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 2012-12-13 00:00:00
9391 1 103471 SUPPL 5120 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,
s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 2012-12-13 00:00:00
9392 1 103471 SUPPL 5136 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,
s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 2012-12-13 00:00:00
9393 1 103471 SUPPL 5186 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5186ltr.pd
f 2015-09-28 00:00:00
9394 1 103471 SUPPL 5188 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5188ltr.pd
f 2015-12-23 00:00:00
9395 1 103532 SUPPL 5175 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103532Orig1s5175ltr.pd
f 2014-12-15 00:00:00
9396 1 103575 SUPPL 1008 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/abcicen110597-
ltr.pdf 2004-03-29 00:00:00
9397 1 103575 SUPPL 5025 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103575-
5025ltr.pdf 2003-12-04 00:00:00
9398 1 103575 SUPPL 5126 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103575Orig1s5126ltr.pd
f 2013-11-27 00:00:00
9399 1 103628 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/ifnbbio051796l.pdf
2004-03-11 00:00:00
9400 1 103628 SUPPL 5008 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbbio111202L.htm
2004-03-11 00:00:00
9401 1 103628 SUPPL 5021 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio052803L.htm
2004-03-11 00:00:00
9402 1 103628 SUPPL 5194 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177
,s5224,s5194ltr.pdf 2014-09-03 00:00:00
9403 1 103628 SUPPL 5258 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103628Orig1s5258ltr.pd
f 2015-12-23 00:00:00
9404 1 103634 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/imcicen070396L.htm
2004-03-17 00:00:00
9409 1 103691 SUPPL 5015 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103691s5015ltr.pdf
2005-05-20 00:00:00
9410 1 103691 SUPPL 5109 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103691s5109ltr.pdf
2012-05-03 00:00:00
9412 1 103705 SUPPL 5211 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5211_ltr.pdf
2006-03-14 00:00:00
9413 1 103705 SUPPL 5230 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5230LTR.pdf
2006-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5256ltr.pdf
2008-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5259ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5262ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5291ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5332ltr.pdf
2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5344ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388
ltr.pdf 2012-10-22 00:00:00
9421 1 103705 SUPPL 5373 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5373ltr.pd
f 2012-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388
ltr.pdf 2012-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5409ltr.pd
f 2013-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5414ltr.pd
f 2013-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/basnova032301L.htm
2004-03-29 00:00:00
9429 1 103764 SUPPL 5037 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/basnov010203L.htm
2004-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103770_s5059_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103770s5113ltr.pdf
2008-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103770s5116ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103770s5153ltr.pdf
2011-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103770s5161ltr.pdf
2012-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/inflcen082498L.htm
2004-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inflcen122900L.htm
2004-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen022702L.pdf
2004-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-
5020ltr.pdf 2003-11-03 00:00:00
9439 1 103772 SUPPL 5032 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/inflcen040103L.htm
2004-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5058ltr.pdf
2004-08-10 00:00:00
9441 1 103772 SUPPL 5092 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5092ltr.pdf
2005-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5113ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5145LTR.pdf
2006-10-23 00:00:00
9444 1 103772 SUPPL 5163 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5163ltr.pdf
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9445 1 103772 SUPPL 5166 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pd
f 2006-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103772s5232ltr.pdf
2009-04-20 00:00:00
9447 1 103772 SUPPL 5258 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5258ltr.pdf
2009-11-25 00:00:00
9448 1 103772 SUPPL 5281 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5281ltr.pdf
2011-02-28 00:00:00
9449 1 103772 SUPPL 5301 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5301ltr.pdf
2011-09-29 00:00:00
9450 1 103772 SUPPL 5317 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5317ltr.pdf
2011-08-11 00:00:00
9451 1 103772 SUPPL 5328 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103772s5328ltr.pdf
2012-06-29 00:00:00
9452 1 103772 SUPPL 5359 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5359ltr.pd
f 2013-11-08 00:00:00
9453 1 103772 SUPPL 5374 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5374ltr.pd
f 2015-09-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbser030702L.htm
2003-12-17 00:00:00
9455 1 103780 SUPPL 5140 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103780Orig1s5140ltr.pd
f 2013-04-24 00:00:00
9456 1 103780 SUPPL 5178 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179
ltr.pdf 2014-04-25 00:00:00
9457 1 103780 SUPPL 5194 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5194ltr.pd
f 2015-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/retboe103096L.htm
2004-03-29 00:00:00
9459 1 103792 SUPPL 5008 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/trasgen082802L.htm
2004-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5175ltr.pdf
2008-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189
ltr.pdf 2014-01-02 00:00:00
9462 1 103792 SUPPL 5189 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189
ltr.pdf 2014-01-02 00:00:00
9463 1 103792 SUPPL 5311 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5311ltr.pd
f 2014-03-11 00:00:00
9464 1 103792 SUPPL 5318 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5313,s5318
ltr.pdf 2014-07-01 00:00:00
9465 1 103792 SUPPL 5327 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103792Orig1s5327ltr.pd
f 2015-04-24 00:00:00
9466 1 103792 SUPPL 5330 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103792Orig1s5330ltr.pd
f 2016-03-18 00:00:00
9467 1 103795 SUPPL 1004 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/etanimm060600L.htm
2004-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-
5099ltr.pdf 2003-11-05 00:00:00
9469 1 103795 SUPPL 5109 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/etanimm060503L.htm
2004-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-
5110ltr.pdf 2003-11-06 00:00:00
9471 1 103795 SUPPL 5125 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-
5125ltr.pdf 2004-04-08 00:00:00
9472 1 103795 SUPPL 5149 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103795_5149l
tr.pdf 2004-06-08 00:00:00
9473 1 103795 SUPPL 5191 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5191ltr.pdf
2005-06-07 00:00:00
9474 1 103795 SUPPL 5229 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5229ltr.pdf
2005-08-08 00:00:00
9475 1 103795 SUPPL 5322 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103795s5322ltr.pdf
2007-03-15 00:00:00
9476 1 103795 SUPPL 5359 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103795s5359ltr.pdf
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9477 1 103795 SUPPL 5391 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400l
tr.pdf 2010-06-29 00:00:00
9478 1 103795 SUPPL 5397 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400l
tr.pdf 2010-06-29 00:00:00
9479 1 103795 SUPPL 5400 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400l
tr.pdf 2010-06-29 00:00:00
9480 1 103795 SUPPL 5431 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5431ltr.pdf
2011-01-27 00:00:00
9481 1 103795 SUPPL 5437 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5437ltr.pdf
2010-08-02 00:00:00
9482 1 103795 SUPPL 5475 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5475ltr.pdf
2011-09-13 00:00:00
9483 1 103795 SUPPL 5503 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5503ltr.pd
f 2012-12-05 00:00:00
9484 1 103795 SUPPL 5507 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5507ltr.pd
f 2012-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103795Orig1s5531ltr.pd
f 2013-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botelan120800L.htm
2004-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103846s5120ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103846s5156ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/tenegen060200L.htm
2004-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/rasbsan071202L.htm
2004-03-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103946_5017ltr.pdf
2005-01-26 00:00:00
9493 1 103946 SUPPL 5094 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103946Orig1s5094ltr.pd
f 2015-02-12 00:00:00
9497 1 103949 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche011901L.htm
2004-03-25 00:00:00
9498 1 103949 SUPPL 5002 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche080701L.htm
2004-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5125ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5153ltr.pdf
2011-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5204ltr.pdf
2011-12-13 00:00:00
9502 1 103949 SUPPL 5231 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949s5231ltr.pdf
2012-06-07 00:00:00
9503 1 103949 SUPPL 5252 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949Orig1s5252ltr.pd
f 2012-12-28 00:00:00
9504 1 103949 SUPPL 5273 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5273ltr.pd
f 2013-11-25 00:00:00
9505 1 103949 SUPPL 5287 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5287ltr.pd
f 2014-09-08 00:00:00
9506 1 103949 SUPPL 5298 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5298ltr.pd
f 2015-05-19 00:00:00
9507 1 103950 SUPPL 5039 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103950_5039ltr.pdf
2004-10-26 00:00:00
9508 1 103950 SUPPL 5136 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103950Orig1s5136ltr.pd
f 2012-12-28 00:00:00
9509 1 103950 SUPPL 5150 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103950Orig1s5150ltr.pd
f 2013-10-25 00:00:00
9510 1 103950 SUPPL 5175 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103950Orig1s5175ltr.pd
f 2016-05-20 00:00:00
9511 1 103951 SUPPL 5069 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103951_5069ltr.pdf
2005-01-26 00:00:00
9512 1 103951 SUPPL 5088 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5088ltr.pdf
2006-02-08 00:00:00
9513 1 103951 SUPPL 5096 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103951s5096ltr.pdf
2005-12-16 00:00:00
9514 1 103951 SUPPL 5173 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,10395
1Orig1s5258ltr.pdf 2011-06-24 00:00:00
9515 1 103951 SUPPL 5258 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,10395
1Orig1s5258ltr.pdf 2011-06-24 00:00:00
9516 1 103951 SUPPL 5285 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103951s5285ltr.pdf
2012-06-04 00:00:00
9517 1 103951 SUPPL 5349 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5349ltr.pd
f 2014-01-02 00:00:00
9518 1 103964 SUPPL 5000 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof120302L.htm
2004-03-25 00:00:00
9519 1 103964 SUPPL 5065 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5065ltr.pdf
2005-05-20 00:00:00
9520 1 103964 SUPPL 5120 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103964s5120ltr.pdf
2007-07-05 00:00:00
9521 1 103964 SUPPL 5133 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5133ltr.pdf
2008-11-07 00:00:00
9522 1 103964 SUPPL 5147 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s516
3ltr.pdf 2009-05-08 00:00:00
9523 1 103964 SUPPL 5163 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s516
3ltr.pdf 2009-05-08 00:00:00
9524 1 103964 SUPPL 5176 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5176ltr.pdf
2010-06-29 00:00:00
9525 1 103964 SUPPL 5177 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5177ltr.pdf
2010-03-31 00:00:00
9526 1 103964 SUPPL 5186 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186
ltr.pdf 2011-08-11 00:00:00
9527 1 103964 SUPPL 5213 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213
ltr.pdf 2011-08-26 00:00:00
9528 1 103976 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/omalgen062003L.htm
2004-03-30 00:00:00
9529 1 103976 SUPPL 5161 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5161ltr.pd
f 2014-10-01 00:00:00
9530 1 103976 SUPPL 5224 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103976Orig1s5224ltr.pd
f 2015-12-08 00:00:00
9531 1 103976 SUPPL 5225 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103976Orig1s5225ltr.pd
f 2016-07-07 00:00:00
9532 1 103979 ORIG 1 0

https://web.archive.org/web/20170202073410/http://www.fda.gov/Drugs/DevelopmentAppr
ovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologi
cApplications/ucm128159.htm 2004-03-15 00:00:00
9533 1 103979 SUPPL 5058 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S50
66LTR.pdf 2007-01-08 00:00:00
9534 1 103979 SUPPL 5065 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S50
66LTR.pdf 2007-01-08 00:00:00
9535 1 103979 SUPPL 5066 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S50
66LTR.pdf 2007-01-08 00:00:00
9538 1 125019 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0058ltr.pdf
2005-01-26 00:00:00
9539 1 125019 SUPPL 135 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125019s0135ltr.pdf
2008-03-28 00:00:00
9540 1 125019 SUPPL 156 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125019s0156ltr.pdf
2009-09-10 00:00:00
9541 1 125019 SUPPL 210 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213lt
r.pdf 2013-09-05 00:00:00
9543 1 125031 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegfamg013102L.htm
2004-03-25 00:00:00
9544 1 125031 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125031_0048ltr.pdf
2005-01-26 00:00:00
9545 1 125031 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125031_0051ltr.pdf
2005-01-26 00:00:00
9546 1 125031 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125031s082ltr.pdf
2007-08-01 00:00:00
9547 1 125031 SUPPL 91 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s091s105ltr.pdf
2008-12-04 00:00:00
9548 1 125031 SUPPL 95 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s0095ltr.pdf
2008-05-22 00:00:00
9549 1 125031 SUPPL 120 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125031s120ltr.pdf
2010-03-31 00:00:00
9550 1 125031 SUPPL 170 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s
181ltr.pdf 2015-09-24 00:00:00
9551 1 125031 SUPPL 175 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125031Orig1s175ltr.pdf
2014-12-30 00:00:00
9552 1 125031 SUPPL 181 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s
181ltr.pdf 2015-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125031Orig1s184ltr.pdf
2016-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm
2004-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/125057_0023l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0045ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s089Ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s094ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s224ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057Orig1s232ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s254ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s271ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s276ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s0278ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s280ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s310ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s356ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s368ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s394ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125057Orig1s397ltr.pdf
2016-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/larobio043003L.htm
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125058s154ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s016
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125058Orig1s220ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084-
0001ltr.pdf 2004-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125084s103ltl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s228ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s229ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s262ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125085s0045ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s082LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125085s091ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s208ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s225ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085s0238ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s239ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s0241ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s265ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s305ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s310ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s312ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125103Orig1s167ltr.pdf
2015-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125104_0000_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s0033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s067ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s106ltr.pdf
2008-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125104s570ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s813ltr.pdf
2013-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955lt
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9611 1 125104 SUPPL 955 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125117_0000_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125118s045ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125118Orig1s171ltr.pdf
2013-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125118Orig1s179ltr.pdf
2015-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125141s0_LTR.pdf
2006-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125147s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125147s0067ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s108ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125147Orig1s152ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125147Orig1s169ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s186ltr.pdf
2014-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125147Orig1s200ltr.pdf
2015-03-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125151s0000_Ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125151s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125156LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125156Orig1s087ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125156Orig1s105ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125156Orig1s106ltr.pdf
2015-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125160s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125160s092ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125160s126ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s142ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125160s157ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s186,s192lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s213ltr.pdf
2013-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s215ltr_rep
lace.pdf 2013-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s241ltr.pdf
2016-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s268ltr.pdf
2016-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125164Orig1s070ltr.pdf
2015-08-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125166s0033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125166s044ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s409ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125166Orig1s412,s413lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s0001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125261s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0059ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s086ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s099ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s103ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125261Orig1s114ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125268Orig1s121ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125268Orig1s155,s156lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125274s0052ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276s0048ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s075ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125276Orig1s105ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125277Orig1s065ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s70ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s071ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s062ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s053ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125289Orig1s070ltr.pdf
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2016-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s133ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s081ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s085ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202106Orig1s000ltr.pdf
2015-05-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202107s000ltr.pdf
2012-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202123Orig1s006ltr.pdf
2012-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s015ltr.pdf
2013-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s016ltr.pdf
2014-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s018ltr.pdf
2014-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.p
df 2016-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.p
df 2016-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202127Orig1s000ltr.pdf
2015-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202144Orig1s006ltr.pdf
2016-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202145Orig1s000ltr.pdf
2013-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202152s000ltr.pdf
2012-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf
2013-01-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s006ltr.pdf
2014-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s009ltr.pdf
2014-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s011ltr.pdf
2015-09-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s012ltr.pdf
2016-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s014ltr.pdf
2016-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202161Orig1s000ltr.pdf
2014-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202167Orig1s000ltr.pdf
2015-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202171s000ltr.pdf
2011-09-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202192s000ltr.pdf
2011-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202192s001ltr.pdf
2012-06-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s003ltr.pdf
2013-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s005ltr.pdf
2013-11-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202192Orig1s012ltr.pdf
2016-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202194s000ltr.pdf
2012-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202207Orig1s000ltr.pdf
2013-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202207Orig1s001ltr.pdf
2014-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202207Orig1s002ltr.pdf
2014-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202231Orig1s003ltr.pdf
2012-12-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202236Orig1s008ltr.pdf
2015-02-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202240Orig1s000ltr.pdf
2015-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202245s000ltr.pdf
2011-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202258Orig1s000Ltr.pdf
2011-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s001ltr.pdf
2012-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258s002ltr.pdf
2012-04-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s003ltr.pdf
2013-02-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s004ltr.pdf
2013-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s007ltr.pdf
2013-02-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s009ltr.pdf
2013-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s011ltr.pdf
2014-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s013ltr.pdf
2014-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s014ltr.pdf
2014-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270s000ltr.pdf
2012-02-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270Orig1s002ltr.pdf
2012-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202270Orig1s003ltr.pdf
2013-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276s000ltr.pdf
2012-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276Orig1s001ltr.pdf
2012-11-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s005ltr.pdf
2014-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s013ltr.pdf
2015-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s000ltr.pdf
2014-01-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s002ltr.pdf
2015-03-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s003ltr.pdf
2014-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s009ltr.pdf
2016-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202308Orig1s000TAltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202309Orig1s000ltr.pdf
2015-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202310Orig1s000ltr.pdf
2015-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202319s000ltr.pdf
2012-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202324s000ltr.pdf
2012-01-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202324Orig1s001ltr.pdf
2013-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s002ltr.pdf
2014-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202331Orig1s002ltr_rep
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s005,202331
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000ltr.pdf
2013-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000TAltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202343s000ltr.pdf
2011-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s006ltr.pdf
2013-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202344Orig1s001ltr.pdf
2013-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202356Orig1s000ltr.pdf
2014-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379s003ltr.pdf
2012-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s005ltr.pdf
2012-12-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202379Orig1s007ltr.pdf
2013-09-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202379Orig1s009ltr.pdf
2014-05-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s015ltr.pdf
2015-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s018ltr.pdf
2015-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202381s000ltr.pdf
2012-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202402Orig1s000ltr.pdf
2016-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202428s000ltr.pdf
2012-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s005ltr.pdf
2014-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s006ltr.pdf
2014-11-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s010ltr.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202439Orig1s008ltr.pdf
2013-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202439Orig1s015ltr.pdf
2015-09-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202440Orig1s000ltr.pdf
2015-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202450Orig1s000ltr.pdf
2012-07-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s002ltr.pdf
2014-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s003ltr.pdf
2014-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202467Orig1s000ltr.pdf
2013-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202468Orig1s000ltr.pdf
2012-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202509Orig1s000ltr.pdf
2014-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202513s000ltr.pdf
2011-12-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202513Orig1s005ltr.pdf
2015-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202514s000ltr.pdf
2012-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202514Orig1s001ltr.pdf
2013-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004lt
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10064 1 202514 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202517Orig1s000ltr.pdf
2014-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202526Orig1s000TAltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202529Orig1s000ltr.pdf
2013-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202535Orig1s000ltr.pdf
2012-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202542Orig1s000ltr.pdf
2013-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202543s000ltr.pdf
2011-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202564Orig1s000ltr.pdf
2015-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202568Orig1s000ltr.pdf
2015-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202570Orig1s000ltr.pdf
2018-12-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s002ltr.pdf
2012-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s004ltr.pdf
2013-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570s007,s009ltr.pdf
2013-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s007,s009lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s013ltr.pdf
2015-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s017ltr.pdf
2016-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s018ltr.pdf
2016-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202573Orig1s000ltr.pdf
2015-01-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202578Orig1s000ltr.pdf
2015-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202589s000ltr.pdf
2012-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202593Orig1s000ltr.pdf
2015-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202608Orig1s000ltr.pdf
2013-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s006ltr.pdf
2015-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202620Orig1s000ltr.pdf
2014-06-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202632Orig1s000ltr.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202645Orig1s000ltr.pdf
2015-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202653Orig1s000ltr.pdf
2013-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202662Orig1s000ltr.pdf
2015-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202667s000ltr.pdf
2012-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202685Orig1s000ltr.pdf
2012-09-24 00:00:00
10094 1 202688 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202688Orig1s000ltr.pdf
2015-08-28 00:00:00
10095 1 202713 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202713Orig1s000ltr.pdf
2015-04-08 00:00:00
10096 1 202714 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s011ltr.pdf
2016-05-25 00:00:00
10097 1 202714 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714s012ltr.pdf
2016-07-06 00:00:00
10098 1 202718 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202718Orig1s000ltr.pdf
2015-01-06 00:00:00
10099 1 202731 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202731Orig1s000TAltr.p
df 2013-12-06 00:00:00
10100 1 202755 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202755Orig1s000ltr.pdf
2016-03-02 00:00:00
10101 1 202763 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202763s000ltr.pdf
2012-02-17 00:00:00
10102 1 202763 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s002ltr.pdf
2014-06-23 00:00:00
10103 1 202763 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202763Orig1s003ltr.pdf
2015-05-13 00:00:00
10104 1 202768 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202768Orig1s000ltr.pdf
2014-10-21 00:00:00
10105 1 202784 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202784Orig1s000ltr.pdf
2015-09-23 00:00:00
10106 1 202788 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006lt
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10107 1 202788 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,0
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10108 1 202788 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s010ltr.pdf
2013-11-12 00:00:00
10109 1 202788 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,0
12ltr.pdf 2014-12-31 00:00:00
10110 1 202799 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s001ltr.pdf
2012-12-06 00:00:00
10111 1 202801 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202801Orig1s000ltr.pdf
2015-01-12 00:00:00
10112 1 202806 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s001ltr.pdf
2013-12-31 00:00:00
10113 1 202806 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202806Orig1s004ltr.pdf
2015-11-23 00:00:00
10114 1 202811 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s007ltr.pdf
2016-04-08 00:00:00
10115 1 202813 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s006ltr.pdf
2014-07-11 00:00:00
10116 1 202813 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009lt
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10117 1 202832 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202832Orig1s001ltr.pdf
2012-10-02 00:00:00
10118 1 202833 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s004ltr.pdf
2015-11-20 00:00:00
10119 1 202833 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s005ltr.pdf
2015-10-07 00:00:00
10120 1 202834 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202834Orig1s000ltr.pdf
2012-10-26 00:00:00
10121 1 202834 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202834Orig1s001ltr.pdf
2013-07-03 00:00:00
10122 1 202834 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s004ltr.pdf
2014-02-19 00:00:00
10123 1 202857 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202857Orig1s000ltr.pdf
2014-09-16 00:00:00
10124 1 202867 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202867Orig1s000ltr.pdf
2014-09-08 00:00:00
10125 1 202873 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202873Orig1s000ltr.pdf
2015-11-30 00:00:00
10126 1 202880 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202880Orig1s000ltr.pdf
2013-10-25 00:00:00
10127 1 202880 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s007ltr.pdf
2016-04-22 00:00:00
10128 1 202895 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002l
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10130 1 202895 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895Orig1s003ltr.pdf
2012-11-14 00:00:00
10131 1 202895 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895
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10132 1 202895 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895
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10133 1 202895 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895
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10134 1 202895 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895
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10135 1 202916 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202916Orig1s000TAltr.p
df 2013-11-20 00:00:00
10136 1 202958 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202958Orig1s000ltr.pdf
2015-03-04 00:00:00
10137 1 202960 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202960Orig1s000ltr.pdf
2014-03-20 00:00:00
10138 1 202971 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202971Orig1s000ltr.pdf
2013-03-01 00:00:00
10139 1 202971 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202971Orig1s003ltr.pdf
2014-12-09 00:00:00
10140 1 202971 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713
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00:00:00
10141 1 202978 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202978s000ltr.pdf
2013-01-23 00:00:00
10142 1 202992 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202992Orig1s000ltr.pdf
2012-09-14 00:00:00
10143 1 202992 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202992Orig1s003ltr.pdf
2016-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203006Orig1s000ltr.pdf
2013-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203010Orig1s000ltr.pdf
2014-02-27 00:00:00
10146 1 203020 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203020Orig1s000ltr.pdf
2015-12-09 00:00:00
10147 1 203041 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203041Orig1s000ltr.pdf
2013-04-04 00:00:00
10148 1 203045 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045
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10149 1 203045 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045
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10150 1 203045 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203053Orig1s000TAltr.p
df 2013-11-06 00:00:00
10152 1 203085 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203085Orig1s004ltr.pdf
2015-04-16 00:00:00
10153 1 203085 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203085Orig1s005ltr.pdf
2016-06-08 00:00:00
10154 1 203093 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203093Orig1s000ltr.pdf
2014-09-26 00:00:00
10155 1 203093 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203093Orig1s002ltr.pdf
2015-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig2s000ltr.pdf
2014-09-29 00:00:00
10157 1 203094 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203094Orig1s005ltr.pdf
2016-06-21 00:00:00
10158 1 203098 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203098Orig1s000ltr.pdf
2013-02-04 00:00:00
10159 1 203098 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203098Orig1s006ltr.pdf
2015-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s004ltr.pdf
2013-10-08 00:00:00
10161 1 203100 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s011ltr.pdf
2014-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203108Orig1s003ltr.pdf
2016-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203109Orig1s000ltr.pdf
2012-09-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;02
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10165 1 203109 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203110Orig1s000ltr.pdf
2015-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203136Orig1s003ltr.pdf
2014-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203137Orig1s002ltr.pdf
2014-12-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203137Orig1s005ltr.pdf
2016-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203152Orig1s000ltr.pdf
2015-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203152Orig1s000TAltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203155Orig1s000ltr.pdf
2012-09-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s001ltredt1.pdf
2013-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s002ltredt1.pdf
2013-09-17 00:00:00
10175 1 203159 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s005ltr.pdf
2016-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203168Orig1s000ltr.pdf
2013-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203176s000ltr.pdf
2012-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s004ltr.pdf
2014-02-25 00:00:00
10179 1 203188 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s007ltr.pdf
2014-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203195s000ltr.pdf
2012-06-07 00:00:00
10182 1 203195 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203202Orig1s000ltr.pdf
2014-02-19 00:00:00
10184 1 203214 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s002ltr.pdf
2013-11-20 00:00:00
10185 1 203214 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s004ltr.pdf
2014-02-25 00:00:00
10186 1 203214 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s005ltr.pdf
2014-03-28 00:00:00
10187 1 203214 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s007ltr.pdf
2014-05-08 00:00:00
10188 1 203214 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s008ltr.pdf
2015-02-17 00:00:00
10189 1 203214 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s011ltr.pdf
2015-12-23 00:00:00
10190 1 203231 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203231Orig1s000ltr.pdf
2013-08-05 00:00:00
10191 1 203231 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s
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10192 1 203231 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203231Orig1s011ltr.pdf
2016-03-29 00:00:00
10193 1 203255 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203255Orig1s000ltr.pdf
2014-12-16 00:00:00
10194 1 203284 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203284Orig1s001ltr.pdf
2014-07-08 00:00:00
10195 1 203314 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203314Orig1s000ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203324Orig1s000ltr.pdf
2016-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203335Orig1s000ltr.pdf
2015-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203341Orig1s000ltr.pdf
2012-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203341Orig1s003ltr.pdf
2015-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203343Orig1s000ltr.pdf
2015-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203377Orig1s000ltr.pdf
2016-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203380Orig1s000ltr.pdf
2016-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203388s000ltr.pdf
2012-01-31 00:00:00
10204 1 203388 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s
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10206 1 203389 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203389Orig1s000ltr_rep
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10207 1 203389 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203389Orig1s010ltr.pdf
2015-08-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203411Orig1s000ltr.pdf
2014-04-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203412Orig1s000TAltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426
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10211 1 203414 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426
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10212 1 203415 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203415Orig1s003ltr.pdf
2014-09-16 00:00:00
10213 1 203415 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s005ltr.pdf
2015-07-22 00:00:00
10214 1 203415 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s007ltr.pdf
2015-10-09 00:00:00
10215 1 203431 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203431Orig1s000ltr.pdf
2015-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203441Orig1s008ltr.pdf
2016-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203455Orig1s000ltr.pdf
2015-12-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s001ltr.pdf
2013-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s002ltr.pdf
2013-08-23 00:00:00
10221 1 203479 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008lt
r.pdf 2015-09-17 00:00:00
10222 1 203479 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479
Orig1s009ltr.pdf 2015-10-02 00:00:00
10223 1 203491 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s000ltr.pdf
2012-10-18 00:00:00
10224 1 203491 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s001ltr.pdf
2012-12-19 00:00:00
10225 1 203491 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203491Orig1s006ltr.pdf
2014-07-08 00:00:00
10226 1 203496 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203496Orig1s001ltr.pdf
2014-10-08 00:00:00
10227 1 203496 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203496Orig1s002ltr.pdf
2016-01-28 00:00:00
10228 1 203505 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203505Orig1s000ltr.pdf
2013-02-28 00:00:00
10229 1 203506 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203506Orig1s000ltr.pdf
2015-04-28 00:00:00
10230 1 203551 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000ltr.pdf
2013-04-16 00:00:00
10231 1 203560 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203560Orig1s000ltr.pdf
2016-03-18 00:00:00
10232 1 203563 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000ltr.pdf
2015-03-11 00:00:00
10233 1 203565 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203565s000ltr.pdf
2013-07-29 00:00:00
10234 1 203568 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203568Orig1s000ltr.pdf
2013-01-31 00:00:00
10235 1 203568 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s004ltr.pdf
2015-02-27 00:00:00
10236 1 203568 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s005ltr.pdf
2015-07-29 00:00:00
10237 1 203568 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203568Orig1s008ltr.pdf
2016-05-25 00:00:00
10238 1 203576 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203576Orig1s000ltr.pdf
2015-10-22 00:00:00
10239 1 203595 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203595Orig1s000ltr.pdf
2013-01-23 00:00:00
10240 1 203613 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203613Orig1s000ltr.pdf
2015-06-22 00:00:00
10241 1 203629 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203629Orig1s000ltr.pdf
2015-01-13 00:00:00
10242 1 203665 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203665Orig1s000ltr.pdf
2013-02-19 00:00:00
10243 1 203667 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s002ltr.pdf
2013-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203683Orig1s000Ltr.pdf
2015-12-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203697Orig1s000ltr.pdf
2013-01-16 00:00:00
10246 1 203752 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203752Orig1s000ltr.pdf
2012-11-01 00:00:00
10247 1 203752 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203752Orig1s004ltr.pdf
2014-09-25 00:00:00
10248 1 203756 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203756Orig1s000ltr.pdf
2012-11-30 00:00:00
10249 1 203790 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000ltr.pdf
2015-10-02 00:00:00
10250 1 203790 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000TAltr.p
df 2015-04-13 00:00:00
10251 1 203794 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003lt
r.pdf 2014-11-19 00:00:00
10252 1 203826 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203826Orig1s000ltr.pdf
2012-12-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203849Orig1s000ltr.pdf
2015-04-08 00:00:00
10254 1 203856 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203856Orig1s000ltr.pdf
2013-09-19 00:00:00
10255 1 203858 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s001ltr.pdf
2013-08-15 00:00:00
10256 1 203858 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s006ltr.pdf
2014-02-19 00:00:00
10257 1 203858 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s009ltr.pdf
2014-08-11 00:00:00
10258 1 203858 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203858Orig1s010ltr.pdf
2015-04-24 00:00:00
10259 1 203952 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203952Orig1s000ltr.pdf
2015-01-15 00:00:00
10260 1 203965 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203965Orig1s000ltr.pdf
2015-03-03 00:00:00
10261 1 203971 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203971Orig1s007ltr.pdf
2016-03-22 00:00:00
10262 1 203975 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203975Orig1s003ltr.pdf
2016-02-26 00:00:00
10263 1 203985 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203985Orig1s000ltr.pdf
2012-08-31 00:00:00
10264 1 203985 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,02
4,203985Orig1s002,004,005_replace_ltr.pdf 2014-02-21 00:00:00
10265 1 203985 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985
Orig1s007ltr.pdf 2014-07-03 00:00:00
10266 1 203985 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203985Orig1s008ltr.pdf
2015-01-26 00:00:00
10267 1 203985 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985
Orig1s010ltr.pdf 2016-02-01 00:00:00
10268 1 203993 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203993Orig1s000ltr.pdf
2012-12-20 00:00:00
10269 1 203993 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202067Orig1s002,203993
Orig1s002ltr.pdf 2013-11-26 00:00:00
10270 1 204005 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204005Orig1s000ltr.pdf
2014-09-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204016Orig1s000ltr.pdf
2015-12-30 00:00:00
10272 1 204026 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s000ltr.pdf
2013-02-11 00:00:00
10273 1 204026 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s002ltr.pdf
2013-11-18 00:00:00
10274 1 204026 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s003ltr.pdf
2014-03-19 00:00:00
10275 1 204026 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,
s008ltr.pdf 2015-04-24 00:00:00
10276 1 204026 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,
s008ltr.pdf 2015-04-24 00:00:00
10277 1 204026 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,
s008ltr.pdf 2015-04-24 00:00:00
10278 1 204026 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s009ltr.pdf
2015-09-16 00:00:00
10279 1 204026 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s010ltr.pdf
2015-10-28 00:00:00
10280 1 204026 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s011ltr.pdf
2015-12-02 00:00:00
10281 1 204026 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014lt
r.pdf 2016-07-01 00:00:00
10282 1 204026 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s013ltr.pdf
2016-04-25 00:00:00
10283 1 204026 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014lt
r.pdf 2016-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204031Orig1s000ltr.pdf
2014-03-13 00:00:00
10285 1 204031 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204031Orig2s001ltr.pdf
2015-03-13 00:00:00
10286 1 204042 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204042Orig1s002ltr.pdf
2014-05-20 00:00:00
10287 1 204042 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s005ltr.pdf
2015-03-04 00:00:00
10288 1 204042 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019lt
r.pdf 2016-05-24 00:00:00
10289 1 204060 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204060Orig1s000ltr.pdf
2016-04-20 00:00:00
10290 1 204063 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204063Orig1s000ltr.pdf
2013-03-29 00:00:00
10291 1 204063 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s009ltr.pdf
2014-11-18 00:00:00
10292 1 204068 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204068Orig1s000ltr.pdf
2016-07-20 00:00:00
10293 1 204078 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204078Orig1s004ltr.pdf
2014-12-12 00:00:00
10294 1 204096 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s001ltr.pdf
2014-02-12 00:00:00
10295 1 204096 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s002ltr.pdf
2014-03-04 00:00:00
10296 1 204096 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204115Orig1s000ltr.pdf
2015-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204119Orig1s000TAltr.p
df 2012-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204137Orig1s000ltr.pdf
2016-07-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.p
df 2013-01-07 00:00:00
10301 1 204150 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002lt
r.pdf 2014-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204152Orig1s000ltr.pdf
2015-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204168Orig1s000ltr.pdf
2013-07-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s002ltr.pdf
2014-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204172Orig1s000ltr.pdf
2015-07-08 00:00:00
10306 1 204200 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640
Orig1s003ltr.pdf 2016-05-19 00:00:00
10307 1 204223 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204223Orig1s000ltr.pdf
2013-11-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204227Orig1s000ltr.pdf
2016-07-13 00:00:00
10309 1 204228 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204228Orig1s000ltr.pdf
2016-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204239Orig1s000ltrl.pd
f 2015-12-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s000ltr.pdf
2013-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204242Orig1s003ltr.pdf
2014-12-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204268Orig1s000ltr.pdf
2015-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s002ltr.pdf
2015-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204278Orig1s000ltr.pdf
2015-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204287Orig1s000TAltr.p
df 2014-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204307Orig1s000ltr.pdf
2013-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204308Orig1s000ltr.pdf
2013-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003lt
r.pdf 2014-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204308Orig1s005ltr.pdf
2016-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204309Orig1s000ltr.pdf
2015-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204311Orig1s000TAltr.p
df 2014-10-24 00:00:00
10324 1 204312 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204312Orig1s000ltr.pdf
2016-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204353Orig1s000ltr.pdf
2014-08-11 00:00:00
10327 1 204353 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s002ltr.pdf
2015-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015lt
r.pdf 2016-05-24 00:00:00
10329 1 204353 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s010ltr.pdf
2016-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s012ltr.pdf
2015-12-08 00:00:00
10331 1 204354 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204354Orig1s000ltr.pdf
2015-11-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204369Orig1s000ltr.pdf
2013-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204370Orig1Orig2s000lt
r.pdf 2015-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204384Orig1s004ltr.pdf
2014-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s006ltr.pdf
2015-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204399Orig1s000TAltr.p
df 2013-08-21 00:00:00
10337 1 204399 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204399Orig1s000ltr.pdf
2014-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204399Orig1s002ltr.pdf
2015-05-13 00:00:00
10339 1 204410 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s007ltr.pdf
2016-02-24 00:00:00
10340 1 204412 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s004ltr.pdf
2014-10-28 00:00:00
10341 1 204412 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204412Orig1s006ltr.pdf
2015-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204421Orig1s000ltr.pdf
2015-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204427Orig1s003ltr.pdf
2015-03-02 00:00:00
10344 1 204447 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204447Orig1s005ltr.pdf
2014-07-21 00:00:00
10345 1 204447 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s007ltr.pdf
2016-05-04 00:00:00
10346 1 204475 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204475Orig1s000ltr.pdf
2016-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204485Orig1s000ltr.pdf
2014-04-18 00:00:00
10348 1 204485 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204485Orig1s002ltr.pdf
2015-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204508Orig1s005ltr.pdf
2016-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000ltr.pdf
2015-12-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000TAltr.p
df 2015-05-28 00:00:00
10352 1 204538 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204538Orig1s000ltr.pdf
2013-11-27 00:00:00
10354 1 204568 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204568Orig1s000TAltr.p
df 2013-12-31 00:00:00
10355 1 204569 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s001ltr.pdf
2014-11-12 00:00:00
10356 1 204569 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204569Orig1s004ltr.pdf
2016-05-31 00:00:00
10357 1 204571 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204571Orig1s000ltr.pdf
2015-08-10 00:00:00
10358 1 204574 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204574Orig1s000ltr.pdf
2016-02-05 00:00:00
10359 1 204592 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204592Orig1s000ltr.pdf
2013-10-22 00:00:00
10360 1 204592 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004lt
r.pdf 2014-08-27 00:00:00
10361 1 204592 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008lt
r.pdf 2016-05-10 00:00:00
10362 1 204592 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008lt
r.pdf 2016-05-10 00:00:00
10363 1 204621 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204621Orig1s000ltr.pdf
2015-11-17 00:00:00
10364 1 204623 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s000ltr.pdf
2014-01-17 00:00:00
10365 1 204623 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s003ltr.pdf
2014-11-07 00:00:00
10366 1 204623 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204623Orig1s005ltr.pdf
2016-05-10 00:00:00
10367 1 204629 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s
003ltr.pdf 2015-06-30 00:00:00
10368 1 204629 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s005ltr.pdf
2016-03-22 00:00:00
10369 1 204629 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s012ltr.pdf
2016-07-12 00:00:00
10370 1 204630 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204630Orig1s000ltr.pdf
2016-04-12 00:00:00
10371 1 204637 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204637Orig1s000TAltr.p
df 2016-02-19 00:00:00
10372 1 204640 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204640Orig1s000ltr.pdf
2013-12-20 00:00:00
10373 1 204640 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204640Orig1s002ltr.pdf
2015-12-30 00:00:00
10374 1 204640 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640
Orig1s003ltr.pdf 2016-05-19 00:00:00
10375 1 204655 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s000ltr.pdf
2014-04-02 00:00:00
10376 1 204655 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s001ltr.pdf
2014-10-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204671Orig1s000ltr.pdf
2013-12-09 00:00:00
10378 1 204671 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s002ltr.pdf
2015-08-21 00:00:00
10379 1 204671 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s004ltr.pdf
2015-03-24 00:00:00
10380 1 204684 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204684Orig1s000ltr.pdf
2014-03-21 00:00:00
10381 1 204706 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204706Orig1s000ltr.pdf
2015-12-09 00:00:00
10382 1 204708 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204708Orig1s000ltr.pdf
2013-08-27 00:00:00
10383 1 204708 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204708Orig1s005ltr.pdf
2016-07-28 00:00:00
10385 1 204736 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204736Orig1s000ltr.pdf
2013-03-28 00:00:00
10386 1 204737 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204737Orig1s000ltr.pdf
2015-07-07 00:00:00
10387 1 204760 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204760Orig1s000ltr.pdf
2014-09-17 00:00:00
10388 1 204760 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s001ltr.pdf
2016-07-26 00:00:00
10389 1 204764 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204764Orig1s000ltr.pdf
2016-03-17 00:00:00
10390 1 204767 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204767Orig1s000ltr.pdf
2015-10-30 00:00:00
10391 1 204768 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204768Orig1s000ltr.pdf
2014-02-26 00:00:00
10392 1 204768 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004lt
r.pdf 2016-05-10 00:00:00
10393 1 204768 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004lt
r.pdf 2016-05-10 00:00:00
10394 1 204785 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204785Orig1s000ltr.pdf
2014-12-03 00:00:00
10395 1 204790 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204790Orig1s000ltr.pdf
2013-08-20 00:00:00
10396 1 204790 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204790Orig1s005ltr.pdf
2015-08-10 00:00:00
10397 1 204806 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204806Orig1s000TAltr.p
df 2014-02-04 00:00:00
10398 1 204819 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s001ltr.pdf
2014-06-12 00:00:00
10399 1 204819 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s002ltr.pdf
2014-05-08 00:00:00
10400 1 204819 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204819Orig1s004ltr.pdf
2015-12-07 00:00:00
10401 1 204822 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204822Orig1s000ltr.pdf
2014-05-20 00:00:00
10402 1 204824 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204824Orig1s003ltr.pdf
2014-11-12 00:00:00
10403 1 204854 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204854Orig1s000ltr.pdf
2015-12-22 00:00:00
10405 1 204886 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204886Orig1s000ltr.pdf
2014-05-09 00:00:00
10406 1 204914 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204914Orig1s000TAltr.p
df 2014-02-11 00:00:00
10407 1 204915 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204915Orig1s000TAltr.p
df 2014-10-24 00:00:00
10409 1 204936 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204936Orig1s000ltr.pdf
2015-04-22 00:00:00
10410 1 204958 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204958Orig1s000ltr.pdf
2015-06-22 00:00:00
10411 1 204979 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204979Orig1s000ltr.pdf
2015-06-03 00:00:00
10412 1 204989 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204989Orig1s000ltr.pdf
2016-02-22 00:00:00
10414 1 205003 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s001ltr.pdf
2015-08-27 00:00:00
10415 1 205029 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s004ltr.pdf
2016-05-19 00:00:00
10418 1 205035 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205035Orig1s000ltr.pdf
2016-01-22 00:00:00
10419 1 205040 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205040Orig1s000TAltr.p
df 2015-04-03 00:00:00
10420 1 205049 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205049Orig1s000ltr.pdf
2016-06-01 00:00:00
10421 1 205082 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205082Orig1s000ltr.pdf
2015-09-09 00:00:00
10422 1 205096 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205096Orig1s000ltr.pdf
2016-07-13 00:00:00
10423 1 205098 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205098Orig1s000ltr.pdf
2013-11-27 00:00:00
10424 1 205098 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205098Origs001ltr.pdf
2014-06-27 00:00:00
10425 1 205098 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205098Orig1s005ltr.pdf
2015-01-09 00:00:00
10426 1 205109 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205109Orig1s000ltr.pdf
2013-11-29 00:00:00
10427 1 205122 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205122Orig1s001ltr.pdf
2015-04-02 00:00:00
10428 1 205122 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205122Orig1s003TAltr.p
df 2016-04-20 00:00:00
10429 1 205123 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s010ltr.pdf
2016-03-02 00:00:00
10430 1 205175 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205175Orig1s000ltr.pdf
2013-10-25 00:00:00
10431 1 205220 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205220Orig1s000ltr.pdf
2016-07-22 00:00:00
10432 1 205223 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205223Orig1s000ltr.pdf
2014-03-25 00:00:00
10433 1 205233 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205233Orig1s000ltr.pdf
2015-12-23 00:00:00
10434 1 205266 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205266Orig1s002ltr.pdf
2016-05-16 00:00:00
10435 1 205318 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205318Orig1s000ltr.pdf
2016-02-03 00:00:00
10436 1 205352 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s000ltr_cor
rected.pdf 2014-01-17 00:00:00
10437 1 205352 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s004ltr.pdf
2015-07-16 00:00:00
10438 1 205356 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205356Orig1s000ltr.pdf
2015-06-02 00:00:00
10439 1 205366 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205366Orig1s000ltr.pdf
2015-12-09 00:00:00
10440 1 205382 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205382Orig1s000ltr.pdf
2014-05-01 00:00:00
10441 1 205383 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205383Orig1s000ltr.pdf
2015-04-03 00:00:00
10442 1 205395 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205395Orig1s000ltr.pdf
2015-02-02 00:00:00
10443 1 205395 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205395Orig1s001ltr.pdf
2016-04-04 00:00:00
10444 1 205410 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205410Orig1s000ltr.pdf
2014-03-19 00:00:00
10445 1 205422 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205422Orig1Orig2s000lt
r.pdf 2015-07-13 00:00:00
10446 1 205425 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205425Orig1s000TAltr.p
df 2015-05-22 00:00:00
10447 1 205434 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205434Orig1s000ltr.pdf
2014-07-25 00:00:00
10448 1 205435 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s005ltr.pdf
2016-06-07 00:00:00
10449 1 205436 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205436Orig1s000ltr.pdf
2014-06-23 00:00:00
10450 1 205436 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436
Orig1s001ltr.pdf 2015-03-06 00:00:00
10451 1 205473 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205473Orig1s000ltr.pdf
2015-08-03 00:00:00
10453 1 205488 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205488Orig1s000ltr.pdf
2014-06-02 00:00:00
10454 1 205490 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205490Orig1s000ltr.pdf
2015-09-04 00:00:00
10455 1 205494 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205494Orig1s000ltr.pdf
2014-08-20 00:00:00
10456 1 205501 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205501Orig1s000ltr.pdf
2015-07-20 00:00:00
10457 1 205519 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205519Orig1s000ltr.pdf
2016-05-24 00:00:00
10458 1 205520 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205520Orig1s000ltr.pdf
2015-07-28 00:00:00
10459 1 205551 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s002ltr.pdf
2015-08-10 00:00:00
10460 1 205551 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s004ltr.pdf
2015-09-30 00:00:00
10461 1 205551 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205551Orig1s005ltr.pdf
2016-04-22 00:00:00
10462 1 205552 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205552Orig1s000ltr.pdf
2013-11-15 00:00:00
10464 1 205552 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig1s001ltr.pdf
2014-07-29 00:00:00
10465 1 205552 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s010,s013lt
r.pdf 2016-05-09 00:00:00
10466 1 205572 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205572Orig1s000ltr.pdf
2015-04-08 00:00:00
10467 1 205579 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205579Orig1s000ltr.pdf
2014-07-24 00:00:00
10469 1 205582 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205582Orig1s000ltr.pdf
2014-01-24 00:00:00
10470 1 205583 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s000ltr.pdf
2014-01-29 00:00:00
10471 1 205596 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205596Orig1s000ltr.pdf
2014-03-14 00:00:00
10472 1 205596 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,2
05053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 2015-11-18 00:00:00
10473 1 205604 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205604Orig1s000ltr.pdf
2015-12-11 00:00:00
10474 1 205605 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205605Orig1s000ltr.pdf
2015-12-11 00:00:00
10475 1 205609 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205609Orig1s000ltr.pdf
2016-07-05 00:00:00
10476 1 205612 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205612Orig1s000ltr.pdf
2016-07-15 00:00:00
10477 1 205613 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000ltr.pdf
2014-10-08 00:00:00
10478 1 205625 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205625Orig1s000ltr.pdf
2014-08-21 00:00:00
10479 1 205625 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205625Orig1s001ltr.pdf
2015-03-24 00:00:00
10480 1 205629 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205629Orig1s000ltr.pdf
2016-07-11 00:00:00
10481 1 205636 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s004ltr.pdf
2016-05-02 00:00:00
10482 1 205637 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205637Orig1s000ltr.pdf
2014-06-10 00:00:00
10483 1 205637 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205637Orig1s004ltr.pdf
2015-02-17 00:00:00
10484 1 205641 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205641Orig1s000ltr.pdf
2014-05-01 00:00:00
10485 1 205641 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641
Orig1s005ltr.pdf 2016-07-13 00:00:00
10486 1 205649 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205649Orig1s000ltr.pdf
2014-10-31 00:00:00
10487 1 205677 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s000ltr.pdf
2014-02-03 00:00:00
10488 1 205677 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s001ltr.pdf
2014-12-16 00:00:00
10489 1 205690 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205690Orig1s000ltr.pdf
2015-11-03 00:00:00
10490 1 205692 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf
2020-03-23 00:00:00
10491 14 205692 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
10492 1 205713 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205713MGLtr.pdf
2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205737MGLtr.pdf
2015-09-30 00:00:00
10494 1 205747 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205747Orig1s000ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004lt
r.pdf 2015-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205764MGLtr.pdf
2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205766MGLtr.pdf
2015-10-02 00:00:00
10498 1 205771 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205771Orig1s000ltr.pdf
2016-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205776Orig1s000ltr.pdf
2014-07-11 00:00:00
10500 1 205776 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205776Orig1s001ltr.pdf
2015-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205777Orig1s002ltr.pdf
2015-07-07 00:00:00
10502 1 205786 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145
Orig1s031,203045Orig1s009ltr.pdf 2013-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205794Orig1s000ltr.pdf
2016-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205804MGLtr.pdf
2015-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205826MGLtr.pdf
2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205828MGLtr.pdf
2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205832Orig1s000ltr.pdf
2014-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205832Orig1s001ltr.pdf
2016-02-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205834Orig1s000ltr.pdf
2014-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005lt
r.pdf 2015-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s004ltr.pdf
2015-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s006ltr.pdf
2015-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s
009ltr.pdf 2016-02-16 00:00:00
10514 1 205834 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s
009ltr.pdf 2016-02-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/0205836Orig1s000,02058
37Orig1s000,0205838Orig1s000ltr.pdf 2016-02-19 00:00:00
10516 1 205838 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/0205836Orig1s000,02058
37Orig1s000,0205838Orig1s000ltr.pdf 2016-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205843MGLtr.pdf
2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205849MGLtr.pdf
2015-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205852MGLtr.pdf
2015-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205858Orig1s000ltr.pdf
2014-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205861Orig1s000TAltr.p
df 2014-08-15 00:00:00
10522 1 205866 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205866MGLtr.pdf
2015-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s000ltr.pdf
2014-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205878Orig1s000ltr.pdf
2015-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205889MGLtr.pdf
2015-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205895Orig1s000TAltr.p
df 2016-01-06 00:00:00
10527 1 205901 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205901Orig1s000ltr.pdf
2016-04-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205909MGLtr.pdf
2015-09-29 00:00:00
10529 1 205910 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205910MGLtr.pdf
2015-09-29 00:00:00
10530 1 205911 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205911Orig1s000ltr.pdf
2015-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s000ltr.pdf
2014-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s001ltr.pdf
2014-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205921Orig1s000ltr.pdf
2014-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205934Orig1s000ltr.pdf
2015-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205941Orig1s000TAltr.p
df 2016-01-22 00:00:00
10536 1 205985 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205985MGLtr.pdf
2015-09-29 00:00:00
10537 1 205986 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205986MGLtr.pdf
2015-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/206014MGLtr.pdf
2015-09-30 00:00:00
10539 1 206038 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206038Orig1s000ltr.pdf
2015-07-02 00:00:00
10540 1 206038 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s001ltr.pdf
2016-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206040Orig1s000TAltr.p
df 2014-09-08 00:00:00
10542 1 206042 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206042Orig1s000TAltr.p
df 2014-09-16 00:00:00
10543 1 206073 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s003ltr.pdf
2015-12-07 00:00:00
10544 1 206073 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s006ltr.pdf
2016-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206099Orig1s000ltr.pdf
2016-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206129Orig1s000ltr.pdf
2015-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206143Orig1s000ltr.pdf
2015-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206192Orig1s000Ltr.pdf
2015-11-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s001ltr.pdf
2015-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206229Orig1s001ltr.pdf
2016-02-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206243Orig1s000ltr.pdf
2015-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206255Orig1s000ltr.pdf
2014-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206276Orig1s000ltr.pdf
2015-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206297Orig1s000ltr.pdf
2015-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206307Orig1s000ltr.pdf
2014-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf
2015-01-09 00:00:00
10558 1 206316 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s002ltr.pdf
2015-09-14 00:00:00
10559 1 206317 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206317Orig1s000ltr.pdf
2015-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206321Orig1s000ltr.pdf
2014-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206323Orig1s000ltr.pdf
2015-06-26 00:00:00
10562 1 206334 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206334Orig1s002ltr.pdf
2016-01-21 00:00:00
10563 1 206352 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206352Orig1s000,21567O
rig1s035ltr.pdf 2014-06-03 00:00:00
10564 1 206352 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s037,206352
Orig1s002ltr.pdf 2015-04-01 00:00:00
10565 1 206353 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s000ltr.pdf
2015-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s001ltr.pdf
2015-07-24 00:00:00
10567 1 206353 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206353Orig1s002ltr.pdf
2016-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206356Orig1s000ltr.pdf
2016-04-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206406Orig1s000ltr.pdf
2015-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206439Orig1s000ltr.pdf
2014-12-30 00:00:00
10571 1 206439 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206439Orig1s003ltr.pdf
2016-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206448Orig1s000ltr.pdf
2015-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206473Orig1s000ltr.pdf
2015-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206493Orig1s000ltr.pdf
2015-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206500Orig1s000ltr.pdf
2015-09-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206510Orig1s000ltr.pdf
2015-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206538Orig1s000ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206544Orig1s000ltr.pdf
2015-10-09 00:00:00
10579 1 206544 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s001ltr.pdf
2016-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206551Orig1s000TAltr.p
df 2016-05-04 00:00:00
10581 1 206552 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206552Orig1s000ltr.pdf
2016-06-14 00:00:00
10582 1 206586 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206586Orig1s000ltr.pdf
2015-07-30 00:00:00
10583 1 206619 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s005ltr.pdf
2015-07-22 00:00:00
10584 1 206619 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s008ltr.pdf
2015-10-26 00:00:00
10585 1 206619 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s009ltr.pdf
2016-04-26 00:00:00
10586 1 206619 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s010ltr.pdf
2016-01-29 00:00:00
10587 1 206619 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s011ltr.pdf
2016-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206623Orig1s000ltr.pdf
2016-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206628Orig1s000ltr.pdf
2015-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206674Orig1s000ltr.pdf
2016-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206679Orig1s000ltr.pdf
2016-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s001ltr.pdf
2015-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s006ltr.pdf
2016-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206781Orig1s000ltr.pdf
2015-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206826MGLtr.pdf
2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206827Orig1s000ltr.pdf
2016-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206829Orig1s000ltr.pdf
2014-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206829Orig1s001ltr.pdf
2015-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206843Orig1s000ltr.pdf
2015-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s001ltr.pdf
2016-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s003ltr.pdf
2016-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206901Orig1s000ltr.pdf
2016-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s000ltr.pdf
2015-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s004ltr.pdf
2016-04-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206995Orig1s000ltr.pdf
2015-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207021Orig1s000ltr.pdf
2016-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207026Orig1s000ltr.pdf
2015-01-15 00:00:00
10608 1 207026 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021703Orig1s016,207026
Orig1s001ltr.pdf 2015-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207042Orig1s000ltr.pdf
2015-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207058Orig1s000ltr.pdf
2016-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207064Orig1s000TAltr.p
df 2015-07-08 00:00:00
10612 1 207103 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207103Orig1s002ltr.pdf
2016-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/207166MGltr.pdf
2015-10-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207318Orig1s000ltr.pdf
2016-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207369Orig1s000TAltr.p
df 2015-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207416Orig1s000ltr.pdf
2015-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207501Orig1s000ltr.pdf
2015-03-06 00:00:00
10618 1 207501 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501
Orig1s001ltr.pdf 2015-04-06 00:00:00
10619 1 207533 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207533Orig1s000ltr.pdf
2015-10-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207589Orig1s000ltr.pdf
2015-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207648Orig1s000ltr.pdf
2016-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207865Orig1s000ltr.pdf
2015-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207884Orig1s000ltr.pdf
2015-11-18 00:00:00
10624 1 207916 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207916Orig1s000ltr.pdf
2016-02-02 00:00:00
10625 1 207917 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207917Orig1s000ltr.pdf
2015-07-20 00:00:00
10626 1 207925 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207925Orig1s000ltr.pdf
2015-03-24 00:00:00
10627 1 207926 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207926Orig1s000ltr.pdf
2015-01-21 00:00:00
10628 1 207930 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207930Orig1s000ltr.pdf
2015-11-03 00:00:00
10629 1 207931 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s000ltr.pdf
2015-07-24 00:00:00
10630 1 207931 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s001ltr.pdf
2015-10-26 00:00:00
10631 1 207931 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s004ltr.pdf
2016-06-23 00:00:00
10632 1 207932 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207932Orig1s000ltr.pdf
2015-10-26 00:00:00
10633 1 207932 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s001ltr.pdf
2016-04-22 00:00:00
10634 1 207946 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207946Orig1s000ltr.pdf
2015-05-21 00:00:00
10635 1 207946 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207958Orig1s002ltr.pdf
2016-02-02 00:00:00
10638 1 207981 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207981Orig1s000ltr.pdf
2015-09-22 00:00:00
10639 1 207986 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207986Orig1s000ltr.pdf
2015-12-14 00:00:00
10640 1 208019 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208019Orig1s000ltr.pdf
2015-08-21 00:00:00
10641 1 208065 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208065Orig1s000Ltr.pdf
2015-11-13 00:00:00
10642 1 208073 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208073Orig1s000ltr.pdf
2016-07-12 00:00:00
10643 1 208081 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208081Orig1s000ltr.pdf
2016-05-16 00:00:00
10644 1 208097 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208097Orig1s000TAltr.p
df 2016-04-27 00:00:00
10645 1 208159 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208159Orig1s000ltr.pdf
2015-12-14 00:00:00
10646 1 208159 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208159Orig1s001ltr.pdf
2016-03-31 00:00:00
10647 1 208169 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208169Orig1s000ltr.pdf
2015-09-10 00:00:00
10648 1 208194 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208194Orig1s000ltr.pdf
2015-12-09 00:00:00
10649 1 208194 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002lt
r.pdf 2016-06-24 00:00:00
10650 1 208216 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208216Orig1s000ltr.pdf
2016-05-04 00:00:00
10651 1 208251 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208251Orig1s000ltr.pdf
2016-05-02 00:00:00
10652 1 208261 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208261Orig1s000ltr.pdf
2016-01-29 00:00:00
10653 1 208289 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208289Orig1s000ltr.pdf
2016-05-04 00:00:00
10654 1 208401 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208401Orig1s000ltr.pdf
2016-08-02 00:00:00
10656 1 208462 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208462Orig1s000ltr.pdf
2015-11-20 00:00:00
10657 1 208547 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208547Orig1s000ltr.pdf
2016-06-06 00:00:00
10658 1 208551 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208551Orig1s000ltr.pdf
2016-04-27 00:00:00
10660 1 761025 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761025Orig1s000ltr.pdf
2015-10-20 00:00:00
10661 1 761033 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761033Orig1s000ltr.pdf
2016-03-29 00:00:00
10662 1 761034 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761034Orig1s000ltr.pdf
2016-05-19 00:00:00
10663 1 761035 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761035Orig1s000ltr.pdf
2015-11-30 00:00:00
10664 1 761036 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761036Orig1s000ltr.pdf
2015-11-17 00:00:00
10665 2 004782 SUPPL 115 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf
2003-04-28 00:00:00
10666 2 004782 SUPPL 128 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.p
df 2002-11-27 00:00:00
10667 2 004782 SUPPL 129 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf
2003-01-07 00:00:00
10668 2 004782 SUPPL 133 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_l
bl.pdf 2004-05-04 00:00:00
10669 2 004782 SUPPL 136 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf
2004-11-17 00:00:00
10670 2 004782 SUPPL 137 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf
2004-08-31 00:00:00
10671 2 004782 SUPPL 139 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf
2005-04-12 00:00:00
10672 2 004782 SUPPL 142 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf
2005-11-03 00:00:00
10673 2 004782 SUPPL 164 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
2011-11-01 00:00:00
10674 2 005010 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005010s049lbl.pdf
2009-03-17 00:00:00
10675 2 005010 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s050lbl.pdf
2011-04-11 00:00:00
10676 2 005010 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s051lbl.pdf
2011-10-31 00:00:00
10677 2 005378 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf
2007-05-16 00:00:00
10678 2 005929 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf
2003-05-08 00:00:00
10679 2 005939 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005939s007lbl.pdf
2007-04-20 00:00:00
10680 2 006035 SUPPL 78 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf
2012-06-25 00:00:00
10681 2 006134 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf
2012-07-12 00:00:00
10682 2 006134 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf
2015-04-07 00:00:00
10683 2 006188 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf
2008-11-28 00:00:00
10684 2 006188 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020lbl.pdf
2010-04-04 00:00:00
10685 2 006188 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf
2011-07-28 00:00:00
10686 2 006188 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006188s024lbl.pdf
2015-02-12 00:00:00
10687 2 006488 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf
2010-02-25 00:00:00
10688 2 006927 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eu
rax_lbl.pdf 2003-07-08 00:00:00
10689 2 007073 SUPPL 128 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/007073s128lbl.pdf
2014-03-05 00:00:00
10690 2 007337 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07337slr029_percodan_lbl.p
df 2004-06-15 00:00:00
10691 2 007337 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/007337s043lbl.pdf
2006-08-14 00:00:00
10692 2 007337 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s045lbl.pdf
2010-03-18 00:00:00
10693 2 007337 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s046lbl.pdf
2010-07-31 00:00:00
10694 2 007517 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf
2009-03-13 00:00:00
10695 2 007961 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf
2011-08-01 00:00:00
10696 2 008173 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08173slr015_benoquin_lbl.p
df 2003-03-28 00:00:00
10697 2 008303 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf
2008-01-22 00:00:00
10698 2 008306 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf
2009-01-02 00:00:00
10699 2 008316 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08316slr015_primaquine_lbl
.pdf 2003-06-22 00:00:00
10700 2 008316 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008316s021lbl.pdf
2015-04-17 00:00:00
10701 2 008370 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf
2011-08-01 00:00:00
10702 2 008370 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.p
df 2013-01-15 00:00:00
10703 2 008453 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf
2010-11-22 00:00:00
10704 2 008578 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.p
df 2003-12-01 00:00:00
10705 2 008678 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf
2016-07-21 00:00:00
10706 2 008762 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf
2011-01-25 00:00:00
10707 2 008762 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043
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10708 2 008762 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf
2013-03-08 00:00:00
10709 2 008762 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.p
df 2014-01-28 00:00:00
10710 2 008809 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf
2004-09-10 00:00:00
10711 2 008809 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf
2012-06-18 00:00:00
10712 2 008809 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf
2013-04-01 00:00:00
10713 2 008816 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf
2004-07-28 00:00:00
10714 2 009000 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf
2002-06-04 00:00:00
10715 2 009053 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09053s024lbl.pdf
2004-07-21 00:00:00
10716 2 009053 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009053s032lbl.pdf
2011-05-31 00:00:00
10717 2 009112 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eu
rax_lbl.pdf 2003-07-08 00:00:00
10718 2 009165 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009165s032lbl.pdf
2014-06-23 00:00:00
10719 2 009170 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf
2010-07-30 00:00:00
10720 2 009190 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf
2014-04-08 00:00:00
10721 2 009218 SUPPL 102 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf
2006-10-05 00:00:00
10722 2 009218 SUPPL 108 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf
2010-01-24 00:00:00
10723 2 009218 SUPPL 115 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf
2015-10-29 00:00:00
10724 2 009321 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf
2015-07-13 00:00:00
10725 2 009330 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009330s026lbl.pdf
2011-11-14 00:00:00
10726 2 009330 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009330s027lbl.pdf
2013-05-21 00:00:00
10727 2 009386 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf
2003-03-06 00:00:00
10728 2 009402 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lb
l.pdf 2004-06-02 00:00:00
10729 2 009435 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf
2010-02-25 00:00:00
10730 2 009818 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009818s018lbl.pdf
2011-07-07 00:00:00
10731 2 009829 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
2003-04-03 00:00:00
10732 2 009830 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf
2005-06-21 00:00:00
10733 2 009866 SUPPL 79 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf
2009-10-05 00:00:00
10734 2 009866 SUPPL 80 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf
2010-07-01 00:00:00
10735 2 010040 SUPPL 171 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010040s171lbl.pdf
2015-07-13 00:00:00
10736 2 010104 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf
2012-11-27 00:00:00
10737 2 010151 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010151s036lbl.pdf
2011-11-16 00:00:00
10738 2 010151 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010151s037lbl.pdf
2013-03-08 00:00:00
10739 2 010151 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.p
df 2014-04-04 00:00:00
10740 2 010151 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.p
df 2016-01-26 00:00:00
10741 2 010151 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.p
df 2016-06-21 00:00:00
10742 2 010155 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s023lbl.pdf
2011-11-14 00:00:00
10743 2 010155 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/010155s024lbl.pdf
2014-12-26 00:00:00
10744 2 010187 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,
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10745 2 010187 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,
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10746 2 010187 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,0212
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10747 2 010187 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.p
df 2010-11-17 00:00:00
10748 2 010187 SUPPL 77 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf
2013-12-17 00:00:00
10749 2 010402 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010402S046lbl.pdf
2004-04-23 00:00:00
10750 2 010402 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010402s063lbl.pdf
2012-04-17 00:00:00
10751 2 010515 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/10515s22lbl.pdf
1999-05-04 00:00:00
10752 2 010515 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010515s031lbl.pdf
2013-03-26 00:00:00
10753 2 010596 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf
2010-10-11 00:00:00
10754 2 010669 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/10669slr028_leukeran_lbl.p
df 2003-12-02 00:00:00
10755 2 010926 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf
2004-11-15 00:00:00
10756 2 011011 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011Orig1s070s071lbl.pdf
2003-05-06 00:00:00
10757 2 011210 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf
2011-01-25 00:00:00
10758 2 011213 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf
2002-05-10 00:00:00
10759 2 011287 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s022lbl.pdf
2009-10-01 00:00:00
10760 2 011340 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf
2002-04-12 00:00:00
10761 2 011522 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf
2005-08-04 00:00:00
10762 2 011522 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013l
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10763 2 011522 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf
2015-10-07 00:00:00
10764 2 011525 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011525s027lbl.pdf
2015-10-08 00:00:00
10765 2 011559 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.p
df 2004-06-01 00:00:00
10766 2 011559 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf
2008-06-12 00:00:00
10767 2 011600 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011600s026lbl.pdf
2016-01-21 00:00:00
10768 2 011641 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011641s065lbl.pdf
2009-09-17 00:00:00
10769 2 011641 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011641s066lbl.pdf
2011-02-04 00:00:00
10770 2 011664 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011664s063lbl.pdf
2016-08-02 00:00:00
10771 2 011665 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
2005-06-21 00:00:00
10772 2 011689 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11689s024lbl.pdf
2004-11-15 00:00:00
10773 2 011707 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011707s031lbl.pdf
2006-10-18 00:00:00
10774 2 011719 SUPPL 106 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_l
bl.pdf 2004-02-03 00:00:00
10775 2 011719 SUPPL 122 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf
2015-11-25 00:00:00
10776 2 011722 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf
2004-09-07 00:00:00
10777 2 011757 SUPPL 85 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf
2009-04-16 00:00:00
10778 2 011757 SUPPL 103 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf
2014-07-09 00:00:00
10779 2 011790 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11790slr046_robaxin_lbl.pd
f 2004-05-04 00:00:00
10780 2 011792 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011792s035lbl.pdf
2006-06-12 00:00:00
10781 2 011839 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf
2007-10-04 00:00:00
10782 2 011839 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf
2015-05-08 00:00:00
10783 2 011839 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf
2015-05-08 00:00:00
10784 2 011856 SUPPL 104 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf
2011-10-25 00:00:00
10785 2 011870 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011870s040lbl.pdf
2009-06-10 00:00:00
10786 2 011909 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/11909slr033_nardil_lbl.pdf
2003-09-09 00:00:00
10787 2 011909 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf
2007-02-21 00:00:00
10788 2 011961 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/11961lbl.pdf 1998-
08-18 00:00:00
10789 2 011963 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011963s034lbl.pdf
2006-03-14 00:00:00
10790 2 012015 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf
2013-04-22 00:00:00
10791 2 012041 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf
2011-06-16 00:00:00
10792 2 012141 SUPPL 89 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf
2012-04-02 00:00:00
10793 2 012141 SUPPL 90 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.p
df 2013-05-09 00:00:00
10794 2 012142 SUPPL 112 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.p
df 2013-05-09 00:00:00
10795 2 012151 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf
2009-01-02 00:00:00
10796 2 012151 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf
2013-06-18 00:00:00
10797 2 012151 SUPPL 72 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf
2014-10-24 00:00:00
10798 2 012209 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf
2016-08-02 00:00:00
10799 2 012250 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf
2005-09-30 00:00:00
10800 2 012342 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12342s055lbl.pdf
2005-01-13 00:00:00
10801 2 012342 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012342s061lbl.pdf
2009-12-02 00:00:00
10802 2 012365 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012365s039lbl.pdf
2013-02-01 00:00:00
10803 2 012366 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012366s031lbl.pdf
2008-11-07 00:00:00
10804 2 012366 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012366s032lbl.pdf
2009-11-16 00:00:00
10805 2 012366 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s033lbl.pdf
2013-02-01 00:00:00
10806 2 012366 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s034lbl.pdf
2013-05-14 00:00:00
10807 2 012380 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf
2010-09-20 00:00:00
10808 2 012380 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034lbl.pdf
2012-05-07 00:00:00
10809 2 012427 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf
2010-02-16 00:00:00
10810 2 012429 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr019_tabloid_lbl.pd
f 2003-07-08 00:00:00
10811 2 012429 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr021_tabloid_lbl.pd
f 2003-12-29 00:00:00
10812 2 012429 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12429s022lbl.pdf
2004-11-16 00:00:00
10813 2 012541 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s084lbl.pdf
2016-06-13 00:00:00
10814 2 012546 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf
2004-09-07 00:00:00
10815 2 012583 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf
2002-06-20 00:00:00
10816 2 012616 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf
2011-05-23 00:00:00
10817 2 012616 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf
2013-06-18 00:00:00
10818 2 012616 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf
2014-10-24 00:00:00
10819 2 012623 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf
2003-05-28 00:00:00
10820 2 012623 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf
2013-08-21 00:00:00
10821 2 012770 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/012770s024lbl.pdf
2016-07-18 00:00:00
10822 2 012787 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf
2013-04-01 00:00:00
10823 2 012787 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf
2013-04-09 00:00:00
10824 2 012806 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf
2013-07-30 00:00:00
10825 2 012892 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/012892Orig1s015s016lbl.pdf
2012-10-04 00:00:00
10826 2 012911 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf
2010-11-04 00:00:00
10827 2 012911 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf
2014-03-04 00:00:00
10828 2 012945 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf
2005-03-18 00:00:00
10829 2 013026 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf
2004-11-15 00:00:00
10830 2 013055 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf
2008-02-14 00:00:00
10831 2 013217 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/13217s036lbl.pdf
2002-08-30 00:00:00
10832 2 013263 SUPPL 83 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf
2008-06-05 00:00:00
10833 2 013684 SUPPL 92 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
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10834 2 013718 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf
2003-06-10 00:00:00
10835 2 013718 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf
2005-06-21 00:00:00
10836 2 014134 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/014134s022lbl.pdf
2010-09-10 00:00:00
10837 2 014214 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf
2004-09-10 00:00:00
10838 2 014214 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014214s057lbl.pdf
2007-05-29 00:00:00
10839 2 014215 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf
2006-07-13 00:00:00
10840 2 014215 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf
2006-07-13 00:00:00
10841 2 014399 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf
2006-04-12 00:00:00
10842 2 014399 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf
2009-10-30 00:00:00
10843 2 014399 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf
2014-07-03 00:00:00
10844 2 014602 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/014602s059lbl.pdf
2015-02-05 00:00:00
10845 2 014685 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14685s026lbl.pdf
2005-01-13 00:00:00
10846 2 014685 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014685s028lbl.pdf
2007-07-31 00:00:00
10847 2 014691 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pd
f 2003-05-28 00:00:00
10848 2 014691 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf
2011-05-02 00:00:00
10849 2 014879 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf
2005-03-23 00:00:00
10850 2 014901 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf
2006-11-22 00:00:00
10851 2 014901 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.p
df 2010-02-04 00:00:00
10852 2 014901 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.pdf
2014-07-09 00:00:00
10853 2 015034 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf
2016-05-11 00:00:00
10854 2 015193 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
2003-05-14 00:00:00
10855 2 015197 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,
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10856 2 015197 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.p
df 2008-08-26 00:00:00
10857 2 015230 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.p
df 2008-08-26 00:00:00
10858 2 015230 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf
2009-02-04 00:00:00
10859 2 015296 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf
2012-11-26 00:00:00
10860 2 015539 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15539s52lbl.pdf
2001-08-08 00:00:00
10861 2 015923 SUPPL 78 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.p
df 2007-05-07 00:00:00
10862 2 015923 SUPPL 79 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s079lbl.pdf
2011-08-16 00:00:00
10863 2 015923 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.p
df 2008-08-29 00:00:00
10864 2 015923 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015923s084lbl.pdf
2009-08-14 00:00:00
10865 2 015923 SUPPL 86 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.p
df 2011-03-04 00:00:00
10866 2 015923 SUPPL 91 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/015923s091lbl.pdf
2015-05-29 00:00:00
10867 2 015923 SUPPL 94 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.p
df 2016-05-20 00:00:00
10868 2 016023 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.p
df 2007-03-07 00:00:00
10869 2 016059 SUPPL 98 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
2016-05-11 00:00:00
10870 2 016092 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf
2005-02-11 00:00:00
10871 2 016096 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mi
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10872 2 016097 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mi
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10873 2 016118 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16118slr023_teslac_lbl.pdf
2003-03-25 00:00:00
10874 2 016126 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16126s25lbl.pdf
2003-06-10 00:00:00
10875 2 016267 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf
2009-02-04 00:00:00
10876 2 016267 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf
2011-12-20 00:00:00
10877 2 016273 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf
2016-03-08 00:00:00
10878 2 016295 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-
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10879 2 016295 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf
2004-04-05 00:00:00
10880 2 016295 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf
2012-01-31 00:00:00
10881 2 016295 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf
2015-07-17 00:00:00
10882 2 016320 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.
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10883 2 016320 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf
2008-11-07 00:00:00
10884 2 016320 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf
2013-02-26 00:00:00
10885 2 016324 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.p
df 2008-07-10 00:00:00
10886 2 016324 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf
2011-05-25 00:00:00
10887 2 016367 SUPPL 178 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf
2005-09-07 00:00:00
10888 2 016367 SUPPL 182 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf
2006-10-27 00:00:00
10889 2 016418 SUPPL 78 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf
2007-09-07 00:00:00
10890 2 016418 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,0176
83s008lbl.pdf 2011-03-22 00:00:00
10891 2 016419 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016419s029lbl.pdf
2015-04-16 00:00:00
10892 2 016466 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf
2009-06-04 00:00:00
10893 2 016517 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016517s011lbl.pdf
2014-03-25 00:00:00
10894 2 016517 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016517s013lbl.pdf
2015-10-22 00:00:00
10895 2 016584 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf
2003-06-16 00:00:00
10896 2 016584 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf
2004-06-09 00:00:00
10897 2 016584 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584s058lbl.pdf
2008-08-26 00:00:00
10898 2 016608 SUPPL 97 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,0189
27s038,020234s026lbl.pdf 2015-09-03 00:00:00
10899 2 016608 SUPPL 98 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf
2007-12-12 00:00:00
10900 2 016608 SUPPL 99 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,0189
27s040,020234s030lbl.pdf 2014-09-19 00:00:00
10901 2 016608 SUPPL 102 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
050,018927s041s042,020234s031s033lbl.pdf 2011-03-07 00:00:00
10902 2 016608 SUPPL 103 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,0189
27s044,020234s035lbl.pdf 2014-01-17 00:00:00
10903 2 016620 SUPPL 72 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016620s072lbl.pdf
2013-09-09 00:00:00
10904 2 016624 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16624s41lbl.pdf
2002-08-23 00:00:00
10905 2 016673 SUPPL 147 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf
2015-01-09 00:00:00
10906 2 016677 SUPPL 139 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-09-07 00:00:00
10907 2 016677 SUPPL 147 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,0180
16s061lbl.pdf 2013-09-17 00:00:00
10908 2 016677 SUPPL 148 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf
2015-01-08 00:00:00
10909 2 016677 SUPPL 150 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016677s150lbl.pdf
2015-06-03 00:00:00
10910 2 016678 SUPPL 105 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,0166
89s105,016696s097,016683s100,016687s102lbl.pdf 2013-09-11 00:00:00
10911 2 016679 SUPPL 104 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,0166
92s095,019367s026lbl.pdf 2011-11-04 00:00:00
10912 2 016687 SUPPL 102 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,0166
89s105,016696s097,016683s100,016687s102lbl.pdf 2013-09-11 00:00:00
10913 2 016689 SUPPL 105 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,0166
89s105,016696s097,016683s100,016687s102lbl.pdf 2013-09-11 00:00:00
10914 2 016693 SUPPL 98 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016693s098lbl.pdf
2016-05-05 00:00:00
10915 2 016696 SUPPL 97 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,0166
89s105,016696s097,016683s100,016687s102lbl.pdf 2013-09-11 00:00:00
10916 2 016697 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,0166
89s105,016696s097,016683s100,016687s102lbl.pdf 2013-09-11 00:00:00
10917 2 016721 SUPPL 77 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
2009-04-03 00:00:00
10918 2 016758 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf
2004-06-09 00:00:00
10919 2 016758 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,01690
4s033lbl.pdf 2008-04-16 00:00:00
10920 2 016758 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf
2009-07-27 00:00:00
10921 2 016762 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,0176
83s008lbl.pdf 2011-03-29 00:00:00
10922 2 016792 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf
2005-01-13 00:00:00
10923 2 016792 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf
2007-08-02 00:00:00
10924 2 016792 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf
2012-12-03 00:00:00
10925 2 016792 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf
2014-07-29 00:00:00
10926 2 016831 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf
2005-10-19 00:00:00
10927 2 016851 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf
2003-06-16 00:00:00
10928 2 016851 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf
2013-02-14 00:00:00
10929 2 016862 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf
2009-10-01 00:00:00
10930 2 016885 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf
2009-02-12 00:00:00
10931 2 016885 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf
2013-11-22 00:00:00
10932 2 016885 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf
2016-03-15 00:00:00
10933 2 016904 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,01690
4s033lbl.pdf 2008-04-16 00:00:00
10934 2 016904 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf
2009-07-27 00:00:00
10935 2 016921 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
10936 2 016921 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
10937 2 016931 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16931slr028_r-
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10938 2 016931 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016931s031lbl.pdf
2010-01-24 00:00:00
10939 2 016949 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf
2016-04-27 00:00:00
10940 2 016954 SUPPL 101 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf
2008-06-26 00:00:00
10941 2 016964 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016964s061lbl.pdf
2005-11-01 00:00:00
10942 2 016964 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016964s069lbl.pdf
2010-02-25 00:00:00
10943 2 016964 SUPPL 70 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016964s070lbl.pdf
2012-01-30 00:00:00
10944 2 016968 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pd
f 2002-11-25 00:00:00
10945 2 016968 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf
2016-01-26 00:00:00
10946 2 016988 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf
2016-07-27 00:00:00
10947 2 017001 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017001s027lbl.pdf
2006-08-11 00:00:00
10948 2 017015 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017015s023lbl.pdf
2010-12-01 00:00:00
10949 2 017029 SUPPL 120 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.p
df 2010-06-24 00:00:00
10950 2 017037 SUPPL 154 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf
2005-09-07 00:00:00
10951 2 017037 SUPPL 158 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf
2006-10-05 00:00:00
10952 2 017037 SUPPL 165 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf
2009-10-16 00:00:00
10953 2 017037 SUPPL 168 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf
2011-03-04 00:00:00
10954 2 017037 SUPPL 169 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf
2012-01-26 00:00:00
10955 2 017058 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017058s017lbl.pdf
2006-12-14 00:00:00
10956 2 017058 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017058s021lbl.pdf
2013-09-24 00:00:00
10957 2 017078 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf
2006-08-11 00:00:00
10958 2 017078 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf
2013-06-18 00:00:00
10959 2 017078 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf
2013-12-12 00:00:00
10960 2 017078 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf
2015-04-20 00:00:00
10961 2 017084 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017084s017lbl.pdf
2009-05-25 00:00:00
10962 2 017087 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017087s047lbl.pdf
2006-09-21 00:00:00
10963 2 017087 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017087s048lbl.pdf
2010-01-24 00:00:00
10964 2 017090 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf
2007-07-16 00:00:00
10965 2 017090 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf
2012-10-26 00:00:00
10966 2 017090 SUPPL 77 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf
2014-07-11 00:00:00
10967 2 017090 SUPPL 78 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf
2014-07-29 00:00:00
10968 2 017105 SUPPL 75 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf
2009-04-28 00:00:00
10969 2 017105 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf
2010-06-14 00:00:00
10970 2 017111 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf
2010-12-04 00:00:00
10971 2 017116 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf
2005-05-27 00:00:00
10972 2 017122 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf
2009-10-01 00:00:00
10973 2 017243 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf
2004-10-22 00:00:00
10974 2 017284 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017284s012lbl.pdf
2011-09-16 00:00:00
10975 2 017340 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
10976 2 017377 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17377s58lbl.pdf
2002-10-17 00:00:00
10977 2 017377 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf
2013-07-17 00:00:00
10978 2 017377 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf
2013-07-17 00:00:00
10979 2 017378 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.p
df 2009-02-04 00:00:00
10980 2 017391 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.p
df 2005-07-29 00:00:00
10981 2 017391 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.p
df 2008-07-10 00:00:00
10982 2 017398 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf
2004-09-29 00:00:00
10983 2 017407 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf
2009-11-13 00:00:00
10984 2 017407 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf
2010-04-19 00:00:00
10985 2 017407 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf
2012-06-06 00:00:00
10986 2 017425 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf
2015-09-21 00:00:00
10987 2 017430 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf
2004-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf
2004-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf
2009-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf
2013-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf
2015-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.
pdf 2012-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.
pdf 2012-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.
pdf 2012-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf
2006-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_ec
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf
2007-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017473s045lbl.pdf
2010-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017473s046lbl.pdf
2011-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf
2011-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017512s108lbl.pdf
2009-01-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,0201
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf
2015-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,0201
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf
2015-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531s10lbl.pdf
2004-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf
2005-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017530s024lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531S010lbl.pdf
2002-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s012lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf
2001-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf
2014-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf
2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042
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11028 2 017576 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf
2008-07-23 00:00:00
11029 2 017577 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-
033,18211se8-016,20897slr010_ditropan_lbl.pdf 2003-04-16 00:00:00
11030 2 017577 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,0208
97s018lbl.pdf 2008-02-14 00:00:00
11031 2 017577 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017577s035lbl.pdf
2009-07-23 00:00:00
11032 2 017577 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s036lbl.pdf
2011-08-08 00:00:00
11033 2 017577 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s037lbl.pdf
2011-12-20 00:00:00
11034 2 017577 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017577s038lbl.pdf
2012-03-23 00:00:00
11035 2 017581 SUPPL 99 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,1
8965s9,10,20067s4,6lbl.pdf 2004-11-16 00:00:00
11036 2 017581 SUPPL 105 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,0181
64s055, 017581s105lbl.pdf 2006-03-14 00:00:00
11037 2 017581 SUPPL 106 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,0189
65s014,020067s011lbl.pdf 2006-01-25 00:00:00
11038 2 017581 SUPPL 108 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s
16,20067s14lbl.pdf 2007-09-26 00:00:00
11039 2 017581 SUPPL 110 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s
18,20067s17lbl.pdf 2008-07-29 00:00:00
11040 2 017588 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017588s036lbl.pdf
2012-11-28 00:00:00
11041 2 017588 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017588s039lbl.pdf
2013-08-21 00:00:00
11042 2 017588 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf
2016-01-07 00:00:00
11043 2 017598 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.p
df 2005-08-03 00:00:00
11044 2 017598 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.p
df 2007-09-11 00:00:00
11045 2 017604 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf
2006-01-20 00:00:00
11046 2 017604 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf
2007-08-14 00:00:00
11047 2 017604 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf
2009-07-24 00:00:00
11048 2 017604 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf
2016-05-11 00:00:00
11049 2 017624 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017624s036lbl.pdf
2010-03-03 00:00:00
11050 2 017628 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.p
df 2006-02-22 00:00:00
11051 2 017651 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.p
df 2010-06-24 00:00:00
11052 2 017693 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf
2015-09-09 00:00:00
11053 2 017735 SUPPL 104 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig
1s086,018985Orig1s050lbl.pdf 2013-10-04 00:00:00
11054 2 017741 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr021lbl.pdf
2003-06-08 00:00:00
11055 2 017741 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr022_florone_lbl.pd
f 2003-12-29 00:00:00
11056 2 017760 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17760s9lbl.pdf
2003-06-16 00:00:00
11057 2 017760 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017760s017lbl.pdf
2013-02-14 00:00:00
11058 2 017765 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pd
f 2003-12-16 00:00:00
11059 2 017766 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17766scs029_nephramine_lbl
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11060 2 017768 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017768s042lbl.pdf
2015-12-15 00:00:00
11061 2 017781 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf
2001-10-03 00:00:00
11062 2 017783 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf
2009-09-17 00:00:00
11063 2 017794 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017794s034s035lbl.pdf
2007-04-20 00:00:00
11064 2 017808 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf
2012-04-20 00:00:00
11065 2 017808 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf
2014-03-13 00:00:00
11066 2 017808 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf
2015-02-03 00:00:00
11067 2 017814 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_0160
59s096lbl.pdf 2006-01-27 00:00:00
11068 2 017814 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf
2016-05-11 00:00:00
11069 2 017824 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17824s024lbl.pdf
2004-10-04 00:00:00
11070 2 017830 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019
s030lbl.pdf 2014-02-25 00:00:00
11071 2 017830 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019
s030lbl.pdf 2014-02-25 00:00:00
11072 2 017830 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019
s030lbl.pdf 2014-02-25 00:00:00
11073 2 017830 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019
s030lbl.pdf 2014-02-25 00:00:00
11074 2 017831 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017831s054lbl.pdf
2006-01-10 00:00:00
11075 2 017831 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s058lbl.pdf
2015-04-10 00:00:00
11076 2 017854 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.p
df 2009-09-22 00:00:00
11077 2 017854 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf
2009-10-08 00:00:00
11078 2 017854 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf
2011-09-23 00:00:00
11079 2 017856 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_to
picort_lbl.pdf 2004-05-04 00:00:00
11080 2 017858 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858Orig1s034lbl.pdf
2011-07-27 00:00:00
11081 2 017858 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858Orig1s035lbl.pdf
2012-08-15 00:00:00
11082 2 017862 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017862s061lbl.pdf
2009-07-09 00:00:00
11083 2 017874 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf
2003-04-10 00:00:00
11084 2 017874 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf
2003-04-11 00:00:00
11085 2 017874 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017874s038lbl.pdf
2013-05-30 00:00:00
11086 14 017881 SUPPL 10 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11087 14 017881 SUPPL 16 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11088 2 017892 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017892s038lbl.pdf
2008-02-14 00:00:00
11089 2 017911 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s068lbl.pdf
2006-01-25 00:00:00
11090 2 017911 SUPPL 70 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017911s070lbl.pdf
2007-08-27 00:00:00
11091 2 017911 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s073lbl.pdf
2010-06-07 00:00:00
11092 2 017919 SUPPL 89 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf
2012-07-13 00:00:00
11093 2 017919 SUPPL 99 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,0189
85s063lbl.pdf 2015-11-04 00:00:00
11094 2 017922 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,0199
55s013lbl.pdf 2007-11-07 00:00:00
11095 2 017955 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
11096 2 017955 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
11097 2 017962 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf
2005-11-17 00:00:00
11098 2 017962 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf
2012-01-06 00:00:00
11099 2 017963 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf
2013-01-11 00:00:00
11100 2 017963 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017963s068lbl.pdf
2013-03-15 00:00:00
11101 2 017970 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf
2002-05-16 00:00:00
11102 2 017970 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf 1998-
10-29 00:00:00
11103 2 017970 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17970slr048_nolvadex_lbl.p
df 2003-06-22 00:00:00
11104 2 017970 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21109lbl,17970s50lbl.pdf
2002-08-30 00:00:00
11105 2 017970 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17970s052lbl.pdf
2004-12-30 00:00:00
11106 2 017971 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_es
kalith_lbl.pdf 2004-06-03 00:00:00
11107 2 017989 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017989s019lbl.pdf
2013-12-17 00:00:00
11108 2 017994 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17994slr022_psorcon_lbl.pd
f 2003-06-08 00:00:00
11109 2 018008 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
11110 2 018012 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf
2005-01-13 00:00:00
11111 2 018012 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.p
df 2012-10-26 00:00:00
11112 2 018012 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf
2014-07-11 00:00:00
11113 2 018013 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf
2005-01-13 00:00:00
11114 2 018013 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf
2014-07-11 00:00:00
11115 2 018013 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf
2014-07-29 00:00:00
11116 2 018016 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018016s056lbl.pdf
2005-05-25 00:00:00
11117 2 018016 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
11118 2 018016 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,0180
16s061lbl.pdf 2013-09-17 00:00:00
11119 2 018016 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf
2015-01-08 00:00:00
11120 2 018027 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf
2002-10-07 00:00:00
11121 2 018027 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf
2011-10-25 00:00:00
11122 2 018029 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,
021284s6s8lbl.pdf 2006-08-09 00:00:00
11123 2 018029 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018029s043lbl.pdf
2010-12-10 00:00:00
11124 2 018029 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.p
df 2013-06-11 00:00:00
11125 2 018029 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,0212
84s027lbl.pdf 2015-04-21 00:00:00
11126 2 018031 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018031s035lbl.pdf
2008-01-08 00:00:00
11127 2 018031 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018031s036lbl.pdf
2010-03-05 00:00:00
11128 2 018031 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf
2011-03-21 00:00:00
11129 2 018035 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf
2011-09-29 00:00:00
11130 2 018037 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,0193
08s023lbl.pdf 2007-04-25 00:00:00
11131 2 018037 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,0193
08s027lbl.pdf 2013-09-11 00:00:00
11132 2 018045 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf
2003-10-31 00:00:00
11133 2 018045 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf
2008-07-10 00:00:00
11134 2 018053 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf
2015-07-13 00:00:00
11135 2 018057 SUPPL 79 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf
2010-09-07 00:00:00
11136 2 018057 SUPPL 80 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf
2011-08-30 00:00:00
11137 2 018057 SUPPL 83 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf
2015-03-02 00:00:00
11138 2 018060 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf
2014-04-16 00:00:00
11139 2 018063 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf
2008-02-14 00:00:00
11140 2 018067 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18067s29lbl.pdf
2002-08-01 00:00:00
11141 2 018081 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.p
df 2014-06-23 00:00:00
11142 2 018081 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
11143 2 018081 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
11144 2 018081 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s056lbl.pdf
2013-09-17 00:00:00
11145 2 018081 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.p
df 2014-12-03 00:00:00
11146 2 018081 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.p
df 2015-01-08 00:00:00
11147 2 018081 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,0187
23s052,019680s039,020593s030,021168s028lbl.pdf 2014-06-10 00:00:00
11148 2 018082 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
11149 2 018082 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
11150 2 018082 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081S056lbl.pdf
2013-09-17 00:00:00
11151 2 018082 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,0187
23s052,019680s039,020593s030,021168s028lbl.pdf 2014-06-10 00:00:00
11152 2 018082 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.p
df 2014-08-22 00:00:00
11153 2 018082 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.p
df 2015-03-17 00:00:00
11154 2 018082 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.p
df 2015-10-06 00:00:00
11155 2 018082 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.p
df 2016-02-23 00:00:00
11156 2 018084 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.p
df 2006-02-22 00:00:00
11157 2 018084 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.p
df 2008-01-24 00:00:00
11158 2 018086 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf
2001-04-12 00:00:00
11159 2 018086 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.p
df 2003-12-29 00:00:00
11160 2 018086 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf
2006-05-01 00:00:00
11161 2 018101 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf
2004-04-27 00:00:00
11162 2 018101 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.p
df 2007-03-07 00:00:00
11163 2 018101 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.p
df 2008-10-03 00:00:00
11164 2 018117 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr032_azmacort_lbl.p
df 2003-09-25 00:00:00
11165 2 018117 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr033_azmacort_lbl.p
df 2003-12-29 00:00:00
11166 2 018117 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018117s042lbl.pdf
2008-03-17 00:00:00
11167 2 018140 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf
2006-12-04 00:00:00
11168 2 018147 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf
2006-01-25 00:00:00
11169 2 018147 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf
2010-08-28 00:00:00
11170 2 018147 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042
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11171 2 018147 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042
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11172 2 018147 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042
lbl.pdf 2015-03-04 00:00:00
11173 2 018154 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf
2015-01-14 00:00:00
11174 2 018163 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf
2010-11-12 00:00:00
11175 2 018163 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf
2008-02-26 00:00:00
11176 2 018164 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s
18,20067s17lbl.pdf 2008-07-29 00:00:00
11177 2 018164 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,0189
65s020,020067s018lbl.pdf 2013-03-26 00:00:00
11178 2 018164 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,0200
67s019lbl.pdf 2016-05-11 00:00:00
11179 2 018185 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf
2016-05-11 00:00:00
11180 2 018185 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf
2016-05-11 00:00:00
11181 2 018201 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-
200S024_Midamor_Prntlbl.pdf 2002-03-21 00:00:00
11182 2 018202 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf
2003-05-13 00:00:00
11183 2 018211 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-
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11184 2 018225 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-
225S018_Bumex_prntlbl.pdf 2002-10-29 00:00:00
11185 2 018225 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf
2010-01-24 00:00:00
11186 2 018234 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18234s020lbl.pdf
2004-10-04 00:00:00
11187 2 018240 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf
2011-08-24 00:00:00
11188 2 018264 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf
2008-11-07 00:00:00
11189 2 018276 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s045lbl.pdf
2011-08-24 00:00:00
11190 2 018279 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf
2013-11-26 00:00:00
11191 2 018279 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf
2014-07-03 00:00:00
11192 2 018281 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,0189
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf
2007-12-12 00:00:00
11194 2 018281 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.p
df 2009-05-12 00:00:00
11195 2 018281 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
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11196 2 018281 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,0189
27s044,020234s035lbl.pdf 2014-01-17 00:00:00
11197 2 018281 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,0189
27s046,020234s038lbl.pdf 2013-03-08 00:00:00
11198 2 018281 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,0189
27s048,020234s040lbl.pdf 2012-12-13 00:00:00
11199 2 018285 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018285s034lbl.pdf
2007-11-07 00:00:00
11200 2 018303 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf
2008-01-08 00:00:00
11201 2 018303 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf
2011-03-21 00:00:00
11202 2 018304 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf
2015-07-13 00:00:00
11203 2 018310 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018310s011lbl.pdf
2007-11-07 00:00:00
11204 2 018327 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018327s005lbl.pdf
2016-03-14 00:00:00
11205 2 018332 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,0183
32s030lbl.pdf 2007-02-02 00:00:00
11206 2 018333 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf
2007-05-01 00:00:00
11207 2 018333 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.p
df 2013-03-08 00:00:00
11208 2 018337 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf
2014-01-28 00:00:00
11209 2 018337 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf
2015-08-13 00:00:00
11210 2 018343 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf
2012-08-28 00:00:00
11212 2 018405 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf
2007-07-06 00:00:00
11213 2 018421 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.p
df 2011-10-25 00:00:00
11214 2 018422 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf
2003-04-14 00:00:00
11215 2 018422 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf
2009-07-17 00:00:00
11216 2 018422 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf
2010-09-27 00:00:00
11217 2 018422 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf
2013-11-01 00:00:00
11218 2 018422 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf
2014-11-07 00:00:00
11219 2 018445 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018445s058lbl.pdf
2007-03-23 00:00:00
11220 2 018449 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.p
df 2007-04-25 00:00:00
11221 2 018452 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,0184
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11222 2 018458 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf
2011-06-29 00:00:00
11223 2 018461 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-
461S050_Lidocaine.pdf 2002-01-23 00:00:00
11224 2 018469 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf
2004-12-30 00:00:00
11225 2 018469 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf
2015-05-14 00:00:00
11226 2 018469 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf
2015-11-12 00:00:00
11227 2 018469 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018469s056lbl.pdf
2016-06-17 00:00:00
11228 2 018482 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf
2013-07-30 00:00:00
11229 2 018487 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf
2016-03-14 00:00:00
11230 2 018489 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf
2015-05-14 00:00:00
11231 2 018533 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf
2014-03-05 00:00:00
11232 2 018538 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf
2009-10-08 00:00:00
11233 2 018553 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf
2011-03-21 00:00:00
11234 2 018557 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.p
df 2004-04-05 00:00:00
11235 2 018562 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,0185
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11236 2 018563 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,0185
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11237 2 018564 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,0185
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf
2005-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf
2010-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018579s029lbl.pdf
2011-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf
2010-05-28 00:00:00
11242 2 018594 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf
2014-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf
2010-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf
2003-04-14 00:00:00
11245 2 018609 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf
2010-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.p
df 2005-12-13 00:00:00
11247 2 018612 SUPPL 72 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072,
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074,
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11249 2 018613 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018613s011lbl.pdf
2003-04-04 00:00:00
11250 2 018613 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018613s017lbl.pdf
2011-12-14 00:00:00
11251 2 018631 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf
2016-02-17 00:00:00
11252 2 018644 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s
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11253 2 018644 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,
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11254 2 018644 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.p
df 2010-05-28 00:00:00
11255 2 018644 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf
2009-07-06 00:00:00
11256 2 018644 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s043lbl.pdf
2011-07-25 00:00:00
11257 2 018644 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf
2013-12-24 00:00:00
11258 2 018651 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf
2003-05-06 00:00:00
11259 2 018651 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf
2005-04-28 00:00:00
11260 2 018651 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf
2006-06-28 00:00:00
11261 2 018652 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf
2014-11-04 00:00:00
11262 2 018657 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidaz
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11263 2 018657 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf
2009-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf
2011-08-12 00:00:00
11265 2 018657 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf
2013-10-25 00:00:00
11266 2 018658 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replace
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf
2001-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf
2002-06-20 00:00:00
11269 2 018662 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_l
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf
2004-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf
2005-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf
2015-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf
2016-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018680s060lbl.pdf
2005-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf
2014-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf
2010-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf
2012-01-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf
2011-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf
2009-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf
2011-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,0202
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,0202
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,0202
51s019lbl.pdf 2009-10-06 00:00:00
11287 2 018704 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.p
df 2009-11-23 00:00:00
11288 2 018705 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018705s017lbl.pdf
2008-10-09 00:00:00
11289 2 018708 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
2013-04-23 00:00:00
11290 2 018708 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
2013-04-23 00:00:00
11291 2 018713 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pd
f 2002-12-15 00:00:00
11292 2 018714 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf
2004-07-21 00:00:00
11293 2 018714 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf
2010-08-01 00:00:00
11294 2 018714 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf
2014-03-05 00:00:00
11295 2 018723 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf
2011-10-12 00:00:00
11296 2 018723 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf
2011-10-12 00:00:00
11297 2 018723 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s041lbl.pdf
2014-06-23 00:00:00
11298 2 018723 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf46lbl.pdf
2011-10-12 00:00:00
11299 2 018723 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf
2011-10-12 00:00:00
11300 2 018723 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf
2011-10-12 00:00:00
11301 2 018723 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s047lbl.pdf
2013-03-04 00:00:00
11302 2 018723 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s048lbl.pdf
2013-09-17 00:00:00
11303 2 018723 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s050lbl.pdf
2014-12-03 00:00:00
11304 2 018723 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s051lbl.pdf
2015-01-08 00:00:00
11305 2 018723 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s053lbl.pdf
2014-08-22 00:00:00
11306 2 018723 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018723s056lbl.pdf
2016-02-23 00:00:00
11307 2 018731 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf
2003-04-14 00:00:00
11308 2 018731 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf
2001-07-19 00:00:00
11309 2 018731 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf
2010-11-22 00:00:00
11310 2 018733 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018733s014lbl.pdf
2008-09-12 00:00:00
11311 2 018737 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.p
df 2003-06-08 00:00:00
11312 2 018738 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.p
df 2003-06-08 00:00:00
11313 2 018738 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf
2009-07-09 00:00:00
11314 2 018741 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf
2006-02-22 00:00:00
11315 2 018748 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18748slr010_loprox_lbl.pdf
2003-03-28 00:00:00
11316 2 018751 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf
2014-04-01 00:00:00
11317 2 018760 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf
2011-08-24 00:00:00
11318 2 018760 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf
2012-11-02 00:00:00
11319 2 018763 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.p
df 2004-05-04 00:00:00
11320 2 018766 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018766s013lbl.pdf
2006-01-25 00:00:00
11321 2 018766 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf
2016-05-11 00:00:00
11322 2 018768 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf
2012-08-03 00:00:00
11323 14 018780 SUPPL 80 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11324 14 018780 SUPPL 86 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11325 14 018780 SUPPL 95 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11326 14 018780 SUPPL 114 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11327 14 018780 SUPPL 120 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11328 14 018780 SUPPL 124 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11329 14 018780 SUPPL 135 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11330 14 018780 SUPPL 148 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11331 14 018781 SUPPL 57 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11332 14 018781 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11333 14 018781 SUPPL 74 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11334 14 018781 SUPPL 76 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11335 14 018781 SUPPL 79 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11336 14 018781 SUPPL 89 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11337 14 018781 SUPPL 108 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11338 14 018781 SUPPL 120 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11339 14 018781 SUPPL 122 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11340 14 018781 SUPPL 154 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11341 14 018781 SUPPL 156 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11342 2 018814 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf
2010-08-28 00:00:00
11343 2 018827 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.
pdf 2003-03-28 00:00:00
11344 2 018827 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf
2008-01-30 00:00:00
11345 2 018827 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf
2009-07-08 00:00:00
11346 2 018827 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf
2014-04-22 00:00:00
11347 2 018828 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20
089slr018_zovirax_lbl.pdf 2004-05-27 00:00:00
11348 2 018828 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf
2016-03-30 00:00:00
11349 2 018840 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018840s028lbl.pdf
2005-06-08 00:00:00
11350 2 018841 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf
2002-01-25 00:00:00
11351 2 018841 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/18841s022lbl.pdf
2014-05-07 00:00:00
11352 2 018851 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf
2016-05-11 00:00:00
11353 2 018858 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf
2016-05-11 00:00:00
11354 2 018874 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf
2012-03-27 00:00:00
11355 2 018878 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf
2007-01-16 00:00:00
11356 2 018883 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig
1s039lbl.pdf 2015-01-12 00:00:00
11357 2 018891 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf
2009-11-13 00:00:00
11358 2 018891 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf
2012-06-06 00:00:00
11359 2 018916 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf
2011-12-23 00:00:00
11360 2 018917 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf
2014-03-17 00:00:00
11361 2 018921 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018921s031lbl.pdf
2015-10-07 00:00:00
11362 2 018922 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018922s021lbl.pdf
2005-05-27 00:00:00
11363 2 018925 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018925s008lbl.pdf
2011-11-04 00:00:00
11364 2 018927 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF
2001-03-07 00:00:00
11365 2 018927 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,0189
27s035,020234s025REVISED_LABEL.pdf 2007-08-17 00:00:00
11366 2 018927 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
050,018927s041s042,020234s031s033lbl.pdf 2011-03-07 00:00:00
11367 2 018927 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
050,018927s041s042,020234s031s033lbl.pdf 2011-03-07 00:00:00
11368 2 018927 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,0189
27s044,020234s035lbl.pdf 2014-01-17 00:00:00
11369 2 018927 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,0189
27s048,020234s040lbl.pdf 2012-12-13 00:00:00
11370 2 018936 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF
2000-07-06 00:00:00
11371 2 018936 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf
2003-01-07 00:00:00
11372 2 018936 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
2009-03-20 00:00:00
11373 2 018936 SUPPL 81 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,
021235s009lbl.pdf 2007-08-03 00:00:00
11374 2 018936 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,
021235s009lbl.pdf 2007-08-03 00:00:00
11375 2 018936 SUPPL 84 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,0212
35s011lbl.pdf 2008-03-24 00:00:00
11376 2 018936 SUPPL 86 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf
2008-06-30 00:00:00
11377 2 018936 SUPPL 88 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,0212
35s014lbl.pdf 2009-02-04 00:00:00
11378 2 018936 SUPPL 91 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf
2011-04-04 00:00:00
11379 2 018936 SUPPL 100 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021l
bl.pdf 2013-07-30 00:00:00
11380 2 018936 SUPPL 102 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf
2014-10-15 00:00:00
11381 2 018938 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,0199
55s010ltr.pdf 2005-11-16 00:00:00
11382 2 018938 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,0199
55s013lbl.pdf 2007-11-07 00:00:00
11383 2 018938 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.p
df 2015-11-19 00:00:00
11384 2 018961 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18961s12lbl.pdf
2002-04-24 00:00:00
11385 2 018965 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,1
8965s9,10,20067s4,6lbl.pdf 2004-11-16 00:00:00
11386 2 018965 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,0181
64s055, 017581s105lbl.pdf 2006-03-14 00:00:00
11387 2 018965 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,0189
65s014,020067s011lbl.pdf 2006-01-25 00:00:00
11388 2 018965 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s
16,20067s14lbl.pdf 2007-09-26 00:00:00
11389 2 018965 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s
18,20067s17lbl.pdf 2008-07-29 00:00:00
11390 2 018965 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,0189
65s020,020067s018lbl.pdf 2013-03-26 00:00:00
11391 2 018965 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf
2016-05-11 00:00:00
11392 2 018972 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf
2004-12-06 00:00:00
11393 2 018972 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf
2009-04-28 00:00:00
11394 2 018972 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf
2009-04-28 00:00:00
11395 2 018972 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf
2009-11-23 00:00:00
11396 2 018972 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf
2010-12-13 00:00:00
11397 2 018972 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf
2015-04-01 00:00:00
11398 2 018972 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf
2015-01-08 00:00:00
11399 2 018972 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf
2016-04-29 00:00:00
11400 2 018976 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018976s012lbl.pdf
2011-05-05 00:00:00
11401 2 018985 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf
2012-07-13 00:00:00
11402 2 018985 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,0189
85s063lbl.pdf 2015-11-04 00:00:00
11403 2 018989 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf
2003-04-23 00:00:00
11404 2 018989 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf
2004-05-26 00:00:00
11405 2 018989 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf
2003-09-30 00:00:00
11406 2 018989 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf
2007-05-07 00:00:00
11407 2 018989 SUPPL 84 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf
2015-12-22 00:00:00
11408 2 018998 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf
2010-05-18 00:00:00
11409 2 018998 SUPPL 77 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf
2012-09-14 00:00:00
11410 2 019009 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19009s6lbl.pdf
2003-04-08 00:00:00
11411 2 019010 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s035lbl.pdf
2011-03-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019010s037lbl.pdf
2014-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19018scs018_trophamine_lbl
.pdf 2004-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019022s021lbl.pdf
2005-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s020lbl.pdf
2013-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s022lbl.pdf
2013-01-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf
2006-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf
2009-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.p
df 2010-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019038s004lbl.pdf
2011-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/019044Orig1s000lbl.pdf
2014-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf
2007-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf
2014-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021,
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf
2009-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf
2010-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf
2006-11-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019111s015lbl.pdf
2008-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019116s009lbl.pdf
2014-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf
2009-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf
2010-04-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf
2011-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf
2013-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019155s022lbl.pdf
2007-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19157s018lbl.pdf
2004-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf
2010-12-26 00:00:00
11446 2 019183 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.p
df 2013-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/019190s036lbl.pdf
2016-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019193s013lbl.pdf
2008-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf
2007-07-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf
2011-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019211s040lbl.pdf
2008-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019211s042lbl.pdf
2009-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf
2006-01-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf
2003-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019221s041lbl.pdf
2011-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019221s044lbl.pdf
2015-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019221s045lbl.pdf
2015-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,0201
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19259slr009_psorcon_lbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019260s007lbl.pdf
2003-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19261s8lbl.pdf
2003-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf
2002-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf
2012-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/019279s010lbl.pdf
2015-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019281s031lbl.pdf
2013-05-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019292s010lbl.pdf
2015-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019297s028lbl.pdf
2005-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf
2009-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf
2010-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035lbl.pdf
2012-03-27 00:00:00
11473 2 019308 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
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11474 2 019309 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019316s018lbl.pdf
2013-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf
2003-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf
2003-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf
2014-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf
2015-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf
2005-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,0166
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf
2004-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf
2004-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf
2006-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf
2006-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf
2008-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf
2009-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf
2011-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf
2011-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf
2012-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf
2012-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf
2013-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf
2013-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf
2016-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf
2012-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19404scp020_ocufen_lbl.pdf
2003-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf
2009-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf
2010-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf
2012-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf
2008-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf
2008-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf
2012-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf
2005-11-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19452s17lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf 2003-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf
2002-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,0202
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.pdf
2015-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf
2016-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19500slr010_lamprene_lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019501Orig1s029lbl.pdf
2015-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf
2006-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf
2002-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19532s12lbl.pdf
2003-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf
2002-04-17 00:00:00
11519 2 019537 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,01
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019537s65lbl.pdf
2007-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s067,020780s025lbl.p
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11523 2 019537 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s4
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s5
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11525 2 019537 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.p
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11526 2 019537 SUPPL 81 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.p
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11527 2 019537 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.p
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11528 2 019555 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf
2014-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf
2012-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACE
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2012-06-11 00:00:00
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2013-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf
2015-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19568scf008_dermatop_lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019568s014lbl.pdf
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2003-03-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,0199
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019583s023lbl.pdf
2005-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf
2002-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf
2003-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591slr022_lariam_lbl.pdf
2003-09-08 00:00:00
11546 2 019591 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf
2008-06-05 00:00:00
11547 2 019591 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf
2009-09-17 00:00:00
11548 2 019591 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591slr027_lbl.pdf
2009-07-24 00:00:00
11549 2 019591 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf
2009-09-17 00:00:00
11550 2 019593 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/019593s028lbl.pdf
1999-10-29 00:00:00
11551 2 019593 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.p
df 2009-03-27 00:00:00
11552 2 019593 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.p
df 2009-10-06 00:00:00
11553 2 019596 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19596s033lbl.pdf
2005-01-26 00:00:00
11554 2 019596 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.p
df 2009-05-25 00:00:00
11555 2 019596 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s049lbl.pdf
2010-12-20 00:00:00
11556 2 019596 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.p
df 2013-10-22 00:00:00
11557 2 019599 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf
2012-01-23 00:00:00
11558 2 019599 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf
2014-10-15 00:00:00
11559 2 019600 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-
ultra_lbl.pdf 2003-03-26 00:00:00
11560 2 019600 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-
ultra_lbl.pdf 2003-03-28 00:00:00
11561 2 019614 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf
2011-11-14 00:00:00
11562 2 019614 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf
2014-10-15 00:00:00
11563 2 019615 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019615s021lbl.pdf
2012-06-18 00:00:00
11564 2 019617 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf
2010-02-16 00:00:00
11565 2 019618 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf
2015-05-26 00:00:00
11566 2 019625 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf
2002-07-17 00:00:00
11567 2 019625 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf
2002-07-17 00:00:00
11568 2 019627 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf
2001-02-23 00:00:00
11569 2 019627 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf
2007-02-21 00:00:00
11570 2 019627 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf
2008-04-23 00:00:00
11571 2 019627 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf
2014-01-28 00:00:00
11572 2 019630 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19630s023lbl.pdf
2004-09-29 00:00:00
11573 2 019634 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19634s021lbl.pdf
2004-10-04 00:00:00
11574 2 019635 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf
2014-09-09 00:00:00
11575 14 019640 SUPPL 40 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11576 14 019640 SUPPL 45 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11577 14 019640 SUPPL 52 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11578 14 019640 SUPPL 68 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11579 14 019640 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11580 14 019640 SUPPL 84 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11581 14 019640 SUPPL 86 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11582 2 019641 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
2003-03-20 00:00:00
11583 2 019641 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19
964slr021_terazol_lbl.pdf 2004-07-01 00:00:00
11584 2 019641 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,0199
64s030lbl.pdf 2013-09-27 00:00:00
11585 2 019643 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf
2007-04-20 00:00:00
11586 2 019643 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf
2003-04-16 00:00:00
11587 2 019643 SUPPL 75 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf
2005-04-12 00:00:00
11588 2 019643 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf
2005-11-08 00:00:00
11589 2 019643 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf
2011-02-04 00:00:00
11590 2 019643 SUPPL 85 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf
2012-02-28 00:00:00
11591 2 019643 SUPPL 87 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf
2012-11-06 00:00:00
11592 2 019645 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf
2007-11-19 00:00:00
11593 2 019645 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf
2013-04-01 00:00:00
11594 2 019649 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf
2004-06-04 00:00:00
11595 2 019649 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019649s015lbl.pdf
2010-04-07 00:00:00
11596 2 019650 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf
2004-06-04 00:00:00
11597 2 019650 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.p
df 2007-03-15 00:00:00
11598 2 019651 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf
2010-05-28 00:00:00
11599 2 019651 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf
2013-10-22 00:00:00
11600 2 019651 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf
2015-05-29 00:00:00
11601 2 019653 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.p
df 2007-05-07 00:00:00
11602 2 019653 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig
1s042lbl.pdf 2013-10-04 00:00:00
11603 2 019653 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf
2012-07-13 00:00:00
11604 2 019653 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,0216
90s001lbl.pdf 2015-05-04 00:00:00
11605 2 019655 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19655s36lbl.pdf
2003-06-16 00:00:00
11606 2 019655 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518
s13lbl.pdf 2006-05-16 00:00:00
11607 2 019655 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,0205
18s016lbl.pdf 2008-09-25 00:00:00
11608 2 019655 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019655s049lbl.pdf
2010-05-18 00:00:00
11609 2 019655 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,0205
18s022lbl.pdf 2011-11-25 00:00:00
11610 2 019658 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf
2015-12-22 00:00:00
11611 2 019661 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
2006-02-02 00:00:00
11612 2 019667 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lb
l.pdf 2003-01-17 00:00:00
11613 2 019667 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf
2008-08-29 00:00:00
11614 2 019667 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf
2015-03-12 00:00:00
11615 2 019668 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf
2015-08-24 00:00:00
11616 2 019668 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf
2013-11-08 00:00:00
11617 2 019668 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf
2016-06-13 00:00:00
11618 2 019670 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf
2004-08-02 00:00:00
11619 2 019670 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032,
020470Orig1s044lbl.pdf 2015-12-11 00:00:00
11620 2 019675 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,0202
51s016lbl.pdf 2005-05-02 00:00:00
11621 2 019675 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,0202
51s018lbl.pdf 2009-03-27 00:00:00
11622 2 019675 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,0202
51s019lbl.pdf 2009-10-06 00:00:00
11623 14 019676 SUPPL 21 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11624 2 019677 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.p
df 2005-12-15 00:00:00
11625 2 019677 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019677s006lbl.pdf
2009-04-03 00:00:00
11626 2 019680 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s3
2,19680s19,20593s11,21168s9lbl.pdf 2006-01-13 00:00:00
11627 2 019680 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33
,19680s22,20593s15,21168s14lbl.pdf 2006-10-18 00:00:00
11628 2 019680 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019680s026lbl.pdf
2009-05-07 00:00:00
11629 2 019680 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf
2011-10-12 00:00:00
11630 2 019680 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s028lbl.pdf
2014-06-23 00:00:00
11631 2 019680 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf
2011-10-12 00:00:00
11632 2 019680 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s034lblupdated.pdf
2013-03-04 00:00:00
11633 2 019680 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s036lbl.pdf
2013-07-02 00:00:00
11634 2 019680 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,0187
23s052,019680s039,020593s030,021168s028lbl.pdf 2014-06-10 00:00:00
11635 2 019683 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019683s027lbl.pdf
2005-10-10 00:00:00
11636 2 019684 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf
2015-01-14 00:00:00
11637 2 019697 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,
019697Orig1s042lbl.pdf 2013-11-20 00:00:00
11638 2 019697 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf
2012-07-13 00:00:00
11639 2 019700 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19700s18lbl.pdf
2003-06-16 00:00:00
11640 2 019700 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf
2005-03-11 00:00:00
11641 2 019700 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019700s028lbl.pdf
2012-06-18 00:00:00
11642 2 019708 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf
2004-09-29 00:00:00
11643 2 019710 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.p
df 2015-07-09 00:00:00
11644 2 019716 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf
2006-08-28 00:00:00
11645 2 019716 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf
2014-08-15 00:00:00
11646 14 019717 SUPPL 32 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11647 14 019717 SUPPL 41 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11648 14 019717 SUPPL 50 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11649 14 019717 SUPPL 52 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11650 14 019717 SUPPL 60 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11651 14 019717 SUPPL 69 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11652 2 019722 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19722slr006_nascobal_lbl.p
df 2003-08-28 00:00:00
11653 2 019726 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf
2009-09-17 00:00:00
11654 2 019726 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf
2009-09-17 00:00:00
11655 2 019726 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019726s054lbl.pdf
2011-01-20 00:00:00
11656 2 019726 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.p
df 2013-06-17 00:00:00
11657 2 019726 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.p
df 2015-02-13 00:00:00
11658 2 019732 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON
%20DEPOT_PRNTLBL.PDF 2003-05-30 00:00:00
11659 2 019732 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s
036,020517s024s028s029lbl.pdf 2010-05-07 00:00:00
11660 2 019732 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s
036,020517s024s028s029lbl.pdf 2010-05-07 00:00:00
11661 2 019732 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019732s037lbl.pdf
2011-01-20 00:00:00
11662 2 019732 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf
2012-02-22 00:00:00
11663 2 019732 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.p
df 2014-07-01 00:00:00
11664 2 019732 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.p
df 2016-06-13 00:00:00
11665 2 019734 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf
2014-07-24 00:00:00
11666 2 019735 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s054LBL.pdf
2006-01-27 00:00:00
11667 2 019735 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s056lbl.pdf
2007-05-29 00:00:00
11668 2 019757 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19757S10lbl.pdf
2003-06-16 00:00:00
11669 2 019758 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19758s44lbl.pdf
2003-06-16 00:00:00
11670 2 019758 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s054lbl.pdf
2005-05-17 00:00:00
11671 2 019758 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf
2005-06-29 00:00:00
11672 2 019758 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf
2015-09-16 00:00:00
11673 2 019758 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s062lbl.pdf
2010-01-20 00:00:00
11674 2 019758 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019758s063lbl.pdf
2011-10-25 00:00:00
11675 2 019758 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
2013-03-26 00:00:00
11676 2 019758 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s073lbl.pdf
2015-01-09 00:00:00
11677 2 019758 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf
2015-09-16 00:00:00
11678 14 019764 SUPPL 20 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11679 14 019764 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11680 14 019764 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11681 14 019764 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11682 14 019764 SUPPL 39 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11683 2 019766 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf
2003-06-16 00:00:00
11684 2 019766 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-
058_zocor_lbl.pdf 2003-04-17 00:00:00
11685 2 019766 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastati
n_lbl.pdf 2003-09-25 00:00:00
11686 2 019766 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastati
n_lbl.pdf 2003-09-25 00:00:00
11687 2 019766 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.
pdf 2004-04-05 00:00:00
11688 2 019766 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.
pdf 2004-04-05 00:00:00
11689 2 019766 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf
2005-09-08 00:00:00
11690 2 019766 SUPPL 75 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf
2007-12-03 00:00:00
11691 2 019766 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf
2008-06-19 00:00:00
11692 2 019766 SUPPL 78 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf
2010-03-02 00:00:00
11693 2 019766 SUPPL 80 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf
2010-04-19 00:00:00
11694 2 019766 SUPPL 85 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf
2012-03-01 00:00:00
11695 2 019766 SUPPL 88 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf
2012-11-02 00:00:00
11696 2 019766 SUPPL 90 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf
2013-10-31 00:00:00
11697 2 019766 SUPPL 91 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf
2014-03-04 00:00:00
11698 2 019766 SUPPL 93 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf
2015-02-03 00:00:00
11699 14 019774 SUPPL 9 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11700 14 019774 SUPPL 19 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11701 14 019774 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11702 2 019777 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s054lbl.pdf
2009-05-25 00:00:00
11703 2 019777 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s056lbl.pdf
2009-11-19 00:00:00
11704 2 019777 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s059lbl.pdf
2012-05-07 00:00:00
11705 2 019777 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s060lbl.pdf
2012-03-29 00:00:00
11706 2 019777 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s061lbl.pdf
2012-11-02 00:00:00
11707 2 019777 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019777s063lbl.pdf
2013-11-21 00:00:00
11708 2 019777 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s064lbl.pdf
2015-01-09 00:00:00
11709 2 019777 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019777s073lbl.pdf
2015-08-26 00:00:00
11710 2 019778 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s045lbl.pdf
2011-02-11 00:00:00
11711 2 019778 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019778s049lbl.pdf
2013-03-01 00:00:00
11712 2 019779 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19779S14lbl.pdf
2002-03-22 00:00:00
11713 2 019779 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf
2004-12-30 00:00:00
11714 2 019781 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19781lbl.pdf 1998-
05-14 00:00:00
11715 2 019781 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.p
df 2011-11-04 00:00:00
11716 2 019785 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf
2008-06-18 00:00:00
11717 2 019787 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019787s042lbl.pdf
2007-11-07 00:00:00
11718 2 019787 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s052lbl.pdf
2011-10-31 00:00:00
11719 2 019787 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s053lbl.pdf
2013-01-07 00:00:00
11720 2 019787 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s054lbl.pdf
2013-01-07 00:00:00
11721 2 019787 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019787s059lbl.pdf
2015-04-09 00:00:00
11722 2 019796 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf
2002-07-17 00:00:00
11723 2 019796 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf
2013-04-01 00:00:00
11724 2 019797 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf
2013-09-23 00:00:00
11725 2 019805 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf
2011-12-23 00:00:00
11726 2 019807 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s002lbl.pdf
2011-08-24 00:00:00
11727 2 019810 SUPPL 85 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019810s085lbl.pdf
2007-05-01 00:00:00
11728 2 019810 SUPPL 87 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pd
f 2008-12-04 00:00:00
11729 2 019810 SUPPL 91 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.p
df 2011-07-06 00:00:00
11730 2 019810 SUPPL 92 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.p
df 2011-01-24 00:00:00
11731 2 019810 SUPPL 93 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.p
df 2011-05-25 00:00:00
11732 2 019810 SUPPL 96 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf
2012-10-01 00:00:00
11733 2 019810 SUPPL 97 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.p
df 2013-05-21 00:00:00
11734 2 019810 SUPPL 101 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl
.pdf 2014-12-29 00:00:00
11735 2 019813 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019813s060lblcorrection.pd
f 2013-09-24 00:00:00
11736 2 019814 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814s12lbl.pdf
2003-06-10 00:00:00
11737 2 019816 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018754s027,019816s010lbl.p
df 2006-01-20 00:00:00
11738 14 019818 SUPPL 42 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11739 14 019818 SUPPL 53 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11740 2 019821 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf
2003-04-28 00:00:00
11741 2 019821 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf
2007-10-22 00:00:00
11742 2 019821 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf
2014-02-19 00:00:00
11743 2 019821 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s024lbl.pdf
2014-05-15 00:00:00
11744 2 019821 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019821s027lbl.pdf
2015-05-21 00:00:00
11745 2 019822 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019822Orig1s007lbl.pdf
2014-01-14 00:00:00
11746 2 019824 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf
2003-03-28 00:00:00
11747 2 019834 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_PRNTLBL.PDF
2004-06-14 00:00:00
11748 2 019834 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19834s17lbl.pdf
2002-05-22 00:00:00
11749 2 019834 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19834slr022_plendil_lbl.pd
f 2004-06-10 00:00:00
11750 2 019835 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019835s032lbl.pdf
2012-12-12 00:00:00
11751 2 019839 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-
839S026_Zoloft_prntlbl.pdf 1999-12-07 00:00:00
11752 2 019839 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-
044,20990se5-010_zoloft_lbl.pdf 2003-09-25 00:00:00
11753 2 019839 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf
2003-03-05 00:00:00
11754 2 019839 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,01
7lbl.pdf 2004-08-25 00:00:00
11755 2 019839 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf
2005-07-14 00:00:00
11756 2 019839 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s
026lbl.pdf 2006-09-15 00:00:00
11757 2 019839 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.p
df 2008-03-07 00:00:00
11758 2 019839 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.p
df 2009-02-04 00:00:00
11759 2 019839 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s
033s036s037lbl.pdf 2011-08-24 00:00:00
11760 2 019839 SUPPL 76 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s
033s036s037lbl.pdf 2011-08-24 00:00:00
11761 2 019839 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s
041lbl.pdf 2014-07-08 00:00:00
11762 2 019839 SUPPL 83 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s
041lbl.pdf 2014-07-08 00:00:00
11763 2 019839 SUPPL 84 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.p
df 2014-09-19 00:00:00
11764 2 019841 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111mal021902LB.pdf
2004-03-16 00:00:00
11765 2 019842 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf
2006-01-25 00:00:00
11766 2 019845 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19845slr017_betopic_lblo.p
df 2003-05-29 00:00:00
11767 2 019845 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019845s021lbl.pdf
2008-06-12 00:00:00
11768 2 019847 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847s
e5-027,20780se5-013_cipro_lbl.pdf 2004-04-05 00:00:00
11769 2 019847 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s03
3,034,036lbl.pdf 2004-07-21 00:00:00
11770 2 019847 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s
035,20780s016lbl.pdf 2005-01-11 00:00:00
11771 2 019847 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857
s41,020780s20,021473s13lbl.pdf 2005-11-17 00:00:00
11772 2 019847 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s5
0,20780s27lbl.pdf 2009-02-20 00:00:00
11773 2 019847 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.p
df 2011-03-04 00:00:00
11774 2 019847 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.p
df 2011-08-16 00:00:00
11775 2 019847 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,0198
57s059,020780s038,021473s033lbl.pdf 2011-11-04 00:00:00
11776 2 019847 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.p
df 2015-03-02 00:00:00
11777 2 019847 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.p
df 2015-03-20 00:00:00
11778 2 019851 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf
2004-04-05 00:00:00
11779 2 019851 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf
2011-06-16 00:00:00
11780 2 019851 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf
2015-07-24 00:00:00
11781 2 019853 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf
2004-11-01 00:00:00
11782 2 019853 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf
2004-11-01 00:00:00
11783 2 019856 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf
2009-01-06 00:00:00
11784 2 019856 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf
2014-07-22 00:00:00
11785 2 019857 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf
2000-08-30 00:00:00
11786 2 019857 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847s
e5-027,20780se5-013_cipro_lbl.pdf 2004-04-05 00:00:00
11787 2 019857 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s03
3,034,036lbl.pdf 2004-07-21 00:00:00
11788 2 019857 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s03
3,034,036lbl.pdf 2004-07-21 00:00:00
11789 2 019857 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019857s46lbl.pdf
2007-06-27 00:00:00
11790 2 019857 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s5
0,20780s27lbl.pdf 2009-02-20 00:00:00
11791 2 019857 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.p
df 2011-03-04 00:00:00
11792 2 019857 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.p
df 2011-08-16 00:00:00
11793 2 019857 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,0198
57s059,020780s038,021473s033lbl.pdf 2011-11-04 00:00:00
11794 2 019857 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019857s062lbl.pdf
2013-08-15 00:00:00
11795 2 019857 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019857s065lbl.pdf
2016-07-26 00:00:00
11796 2 019858 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf
2000-08-30 00:00:00
11797 2 019862 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111med021902LB.pdf
2004-03-16 00:00:00
11798 2 019865 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-
865S010_Betapace_prntlbl.pdf 2001-10-01 00:00:00
11799 2 019865 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf
2016-05-11 00:00:00
11800 2 019872 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pd
f 2003-06-08 00:00:00
11801 2 019872 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf
2009-06-29 00:00:00
11802 2 019872 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf
2014-01-09 00:00:00
11803 2 019872 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf
2014-03-27 00:00:00
11804 2 019872 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf
2014-12-15 00:00:00
11805 2 019881 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019881s002lbl.pdf
2003-05-06 00:00:00
11806 2 019884 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf
2014-03-19 00:00:00
11807 2 019885 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf
2009-10-01 00:00:00
11808 2 019885 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf
2011-10-20 00:00:00
11809 2 019885 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf
2012-09-25 00:00:00
11810 2 019885 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf
2013-09-23 00:00:00
11811 2 019885 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf
2013-10-31 00:00:00
11812 2 019885 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf
2015-09-14 00:00:00
11813 2 019886 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
2011-01-11 00:00:00
11814 2 019886 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019886s032lbl.pdf
2015-08-10 00:00:00
11815 2 019888 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s047lbl.pdf
2009-11-19 00:00:00
11816 2 019888 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s053lbl.pdf
2012-11-02 00:00:00
11817 2 019888 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019888s055lbl.pdf
2013-11-08 00:00:00
11818 2 019888 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019888s056lbl.pdf
2015-01-09 00:00:00
11819 2 019888 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019888s065lbl.pdf
2015-08-26 00:00:00
11820 2 019891 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.p
df 2006-06-12 00:00:00
11821 2 019892 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.p
df 2006-06-12 00:00:00
11822 2 019892 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf
2007-11-19 00:00:00
11823 2 019898 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf
2002-07-12 00:00:00
11824 2 019898 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.
pdf 2003-09-25 00:00:00
11825 2 019898 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf
2005-07-15 00:00:00
11826 2 019898 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf
2007-03-07 00:00:00
11827 2 019898 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf
2011-05-23 00:00:00
11828 2 019898 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf
2012-02-28 00:00:00
11829 2 019898 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf
2016-07-08 00:00:00
11830 2 019901 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019901s055lbl.pdf
2010-10-25 00:00:00
11831 2 019901 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019901s058lbl.pdf
2011-09-02 00:00:00
11832 2 019901 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019901s059lbl.pdf
2012-04-20 00:00:00
11833 2 019901 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s063lbl.pdf
2013-10-31 00:00:00
11834 2 019906 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf
2005-01-13 00:00:00
11835 2 019906 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf
2007-07-16 00:00:00
11836 2 019906 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf
2012-10-26 00:00:00
11837 2 019906 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf
2014-07-11 00:00:00
11838 2 019906 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf
2014-07-29 00:00:00
11839 2 019908 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf
2007-03-31 00:00:00
11840 2 019908 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf
2008-05-28 00:00:00
11841 2 019908 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s
015lbl.pdf 2013-04-23 00:00:00
11842 2 019909 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19909s16s17lbl.pdf
2003-06-10 00:00:00
11843 2 019909 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20
089slr018_zovirax_lbl.pdf 2004-05-27 00:00:00
11844 2 019910 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19910s24lbl.pdf
2003-06-10 00:00:00
11845 2 019910 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20
528slr011_retrovir_lbl.pdf 2003-10-17 00:00:00
11846 2 019910 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518
s13lbl.pdf 2006-05-16 00:00:00
11847 2 019910 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019910s032lbl.pdf
2006-11-16 00:00:00
11848 2 019910 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019910s035lbl.pdf
2009-11-19 00:00:00
11849 2 019910 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019910s036lbl.pdf
2010-05-18 00:00:00
11850 2 019916 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019916s004lbl.pdf
2006-11-06 00:00:00
11851 2 019927 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019927s031lbl.pdf
2012-12-05 00:00:00
11852 2 019927 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019927s032lbl.pdf
2013-10-31 00:00:00
11853 2 019931 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pd
f 2004-06-07 00:00:00
11854 2 019937 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf
2009-11-19 00:00:00
11856 14 019938 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11857 14 019938 SUPPL 33 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11858 14 019938 SUPPL 48 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11859 14 019938 SUPPL 71 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11860 14 019938 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11861 14 019938 SUPPL 74 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
11862 1 009165 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s002ltr.pdf
2007-03-15 00:00:00
11863 1 009165 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009165Orig1s033ltr.pdf
2015-05-13 00:00:00
11864 1 009170 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009170s031ltr.pdf
2008-06-16 00:00:00
11865 1 009170 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s036ltr.pdf
2009-05-01 00:00:00
11866 1 009170 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009170s038ltr.pdf
2011-08-12 00:00:00
11867 1 009175 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009175s033ltr.pdf
2008-06-03 00:00:00
11868 1 009175 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009175Orig1s036ltr.pdf
2013-11-07 00:00:00
11869 1 009193 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf
2003-04-16 00:00:00
11870 1 009218 SUPPL 99 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s099ltr.pdf
2002-05-03 00:00:00
11871 1 009218 SUPPL 102 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/009218s102LTR.pdf
2006-10-05 00:00:00
11872 1 009218 SUPPL 108 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009218s108ltr.pdf
2010-01-28 00:00:00
11873 1 009330 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009330s026ltr.pdf
2011-11-16 00:00:00
11874 1 009330 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009330Orig1s027ltr.pdf
2013-05-22 00:00:00
11875 1 009386 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386scm019ltr.pdf
2003-01-23 00:00:00
11876 1 009386 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr021ltr.pdf
2003-05-16 00:00:00
11877 1 009386 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr023ltr.pdf
2004-01-09 00:00:00
11878 1 009435 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09435slr034ltr.pdf
2004-06-23 00:00:00
11879 1 009435 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf
2010-03-18 00:00:00
11880 1 009470 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009470Orig1s025ltr.pdf
2014-09-25 00:00:00
11881 1 009768 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009768s041ltr.pdf
2007-07-05 00:00:00
11882 1 009818 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009818s018ltr.pdf
2011-07-07 00:00:00
11883 1 009866 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s079ltr.pdf
2009-11-09 00:00:00
11884 1 009866 SUPPL 104 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009866Orig1s104ltr.pdf
2014-07-08 00:00:00
11885 1 010040 SUPPL 168 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10040slr168ltr.pdf
2002-10-23 00:00:00
11886 1 010040 SUPPL 171 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010040Orig1s171ltr.pdf
2015-07-10 00:00:00
11887 1 010060 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10060slr017ltr.pdf
2004-06-30 00:00:00
11888 1 010104 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10104slr022ltr.pdf
2004-03-02 00:00:00
11889 1 010104 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010104s028ltr.pdf
2010-01-26 00:00:00
11890 1 010151 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.p
df 2001-11-20 00:00:00
11891 1 010151 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.p
df 2001-11-20 00:00:00
11892 1 010151 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010151s036ltr.pdf
2011-11-21 00:00:00
11893 1 010151 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s051,010151
Orig1s039ltr.pdf 2014-04-04 00:00:00
11894 1 010155 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10155slr021ltr.pdf
2003-03-10 00:00:00
11895 1 010155 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/010155Orig1s024ltr.pdf
2014-11-28 00:00:00
11896 1 010187 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029
Orig1s047,021284Orig1s023ltr.pdf 2013-12-16 00:00:00
11897 1 010251 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10251scm024ltr.pdf
2002-10-18 00:00:00
11898 1 010379 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10379S047ltr.pdf
2002-05-17 00:00:00
11899 1 010402 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr
.pdf 2005-01-21 00:00:00
11900 1 010402 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054l
tr.pdf 2005-09-07 00:00:00
11901 1 010402 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050,
020216s055LTR.pdf 2006-08-04 00:00:00
11902 1 010402 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/010402Orig1s063ltr.pdf
2012-04-13 00:00:00
11903 1 010485 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF
2001-03-21 00:00:00
11904 1 010515 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/10515s22ltr.pdf
1999-05-04 00:00:00
11905 1 010571 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010571s096ltr.pdf
2005-08-08 00:00:00
11906 1 010596 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010596s021ltr.pdf
2009-04-29 00:00:00
11907 1 010596 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010596s022ltr.pdf
2010-10-13 00:00:00
11908 1 010596 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010596s023ltr.pdf
2011-06-17 00:00:00
11909 1 010669 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf
2001-07-24 00:00:00
11910 1 010669 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s24ltr.pdf
2001-06-20 00:00:00
11911 1 010775 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10775S29ltr.pdf
2001-03-15 00:00:00
11912 1 010841 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf
2003-10-01 00:00:00
11913 1 010841 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010841s022ltr.pdf
2010-06-14 00:00:00
11914 1 010926 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,02
2ltr.pdf 2002-12-26 00:00:00
11915 1 010926 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,02
2ltr.pdf 2002-12-26 00:00:00
11916 1 010996 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997sl
r043,%2016862slr033ltr.pdf 2002-08-01 00:00:00
11917 1 010997 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s
041,042,017122s061,062ltr.pdf 2009-11-13 00:00:00
11918 1 011000 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
2001-04-03 00:00:00
11919 1 011011 SUPPL 71 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/011011Orig1s070,s071lt
r.pdf 2003-05-01 00:00:00
11920 1 011111 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF
2001-03-21 00:00:00
11921 1 011120 SUPPL 86 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11120S86ltr.pdf
2001-04-03 00:00:00
11922 1 011145 SUPPL 91 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s03
6ltr.pdf 2004-09-29 00:00:00
11923 1 011188 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
2001-04-03 00:00:00
11924 1 011210 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011210s053ltr.pdf
2011-01-25 00:00:00
11925 1 011213 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10775S29ltr.pdf
2001-03-15 00:00:00
11926 1 011245 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011245s032ltr.pdf
2005-08-31 00:00:00
11927 1 011287 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011287s022ltr.pdf
2009-11-19 00:00:00
11928 1 011287 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011287s023ltr.pdf
2011-01-05 00:00:00
11929 1 011324 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11324s28ltr.pdf
2002-04-17 00:00:00
11930 1 011340 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11340s16ltr.pdf
2002-04-12 00:00:00
11931 1 011366 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011366s028ltr.pdf
2012-03-19 00:00:00
11932 1 011366 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011366Orig1s030ltr.pdf
2015-08-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF
2001-03-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/011483Orig1s027ltr.pdf
2013-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s041ltr.pdf
2015-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11559s32ltr.pdf
2001-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11559scm033ltr.pdf
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11559slr037ltr.pdf
2004-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011613Orig1s027ltr.pdf
2012-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011641s066ltr.pdf
2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11664slr062ltr.pdf
2004-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,02
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2004-11-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011707s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf
2002-02-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr105ltr.pdf
2003-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719slr106ltr.pdf
2004-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719s107ltr.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011719s108ltr.pdf
2005-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011719s117ltr.pdf
2011-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011719Orig1s122ltr.pdf
2015-11-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf
2009-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf
2009-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11790slr046ltr.pdf
2004-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011792s041ltr.pdf
2007-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011792s043ltr.pdf
2010-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011792Orig1s046ltr.pdf
2015-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11839S68LTR.PDF
1998-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011839s071ltr.pdf
2007-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011839Orig1s079,s080lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf
2011-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/011856s107ltr.pdf
2010-06-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011856Orig1s123ltr.pdf
2014-07-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011870s039ltr.pdf
2007-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011870s040ltr.pdf
2009-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11909s035ltr.pdf
2005-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011909s036ltr.pdf
2007-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11961ltr.pdf
1998-08-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11961s035ltr.pdf
2005-01-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf
2001-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012041s033ltr.pdf
2006-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012041Orig1s042,014901
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12093s44ltr.pdf
2001-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012093Orig1s052ltr.pdf
2015-01-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012141s089ltr.pdf
2012-04-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012141Orig1s090,012142
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12142scf107ltr.pdf
2003-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012151s062ltr.pdf
2008-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012151s067ltr.pdf
2011-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12154slr023ltr.pdf
2004-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12223S36ltr.pdf
2001-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012250s028ltr.pdf
2005-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12281slr050,051,051ltr
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11997 1 012342 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
2001-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
2001-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
2001-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
2001-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012342s056s057ltr.pdf
2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012342s063ltr.pdf
2010-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012365s035ltr.pdf
2009-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012366s031ltr.pdf
2008-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012366s032ltr.pdf
2010-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012365s039,012366s033l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012366Orig1s034ltr.pdf
2013-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf
2001-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12380s029.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012380s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12429s17ltr.pdf
2003-05-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12429slr021ltr.pdf
2003-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12429s022ltr.pdf
2004-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012541Orig1s083ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012541Orig1s084ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11722s029,12546s032ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12583s028,s037LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s068ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s069ltr.pdf
2011-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012616Orig1s073ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s074ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s075ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12623slr059ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012623Orig1s066ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012802s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012802Orig1s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12806scm028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12836s054ltr.pdf
2004-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012911s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12945s037,038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013217s046ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013217s053ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13400s086ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s091ltr.pdf
2005-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13718s20s21ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13718slr022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13790scm018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/013790s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14134slr024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014214s058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014214s059ltr.pdf
2011-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014399s064ltr.pdf
2007-07-31 00:00:00
12064 1 014399 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014399s065ltr.pdf
2009-11-19 00:00:00
12065 1 014399 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067lt
r.pdf 2012-11-21 00:00:00
12066 1 014602 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014602s019ltr.pdf
2006-07-21 00:00:00
12067 1 014602 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/014602Orig1s059ltr.pdf
2015-02-06 00:00:00
12068 1 014685 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14685s026ltr.pdf
2005-01-13 00:00:00
12069 1 014685 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014685s028ltr.pdf
2007-07-31 00:00:00
12070 1 014691 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/14691slr024ltr.pdf
2003-06-08 00:00:00
12071 1 014691 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016l
tr.pdf 2011-06-14 00:00:00
12072 1 014713 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14713s031ltr.pdf
2002-05-10 00:00:00
12073 1 014879 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14879slr040ltr.pdf
2004-04-20 00:00:00
12074 1 014901 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012041s036,01401s037lt
r.pdf 2010-02-05 00:00:00
12075 1 014901 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039l
tr.pdf 2011-07-19 00:00:00
12076 1 015193 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/15193s020ltr.pdf
2002-05-22 00:00:00
12077 1 015197 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp
038,scm039ltr.pdf 2004-06-25 00:00:00
12078 1 015197 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15
230s031ltr.pdf 2004-08-25 00:00:00
12079 1 015197 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035,
015197s043ltr.pdf 2008-08-22 00:00:00
12080 1 015229 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15
230s031ltr.pdf 2004-08-25 00:00:00
12081 2 019941 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf
2006-05-01 00:00:00
12082 2 019943 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.p
df 2010-10-29 00:00:00
12083 2 019949 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20
090slr019_diflucan_lbl.pdf 2004-04-05 00:00:00
12084 2 019949 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,0200
90s031lbl.pdf 2010-08-10 00:00:00
12085 2 019949 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,0200
90s036lbl.pdf 2011-04-29 00:00:00
12086 2 019949 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,0200
90s040lbl.pdf 2013-09-17 00:00:00
12087 2 019949 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,0200
90s042lbl.pdf 2014-03-25 00:00:00
12088 2 019950 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33
,37,20090s12,14,17lbl.pdf 2004-10-08 00:00:00
12089 2 019950 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20
090slr019_diflucan_lbl.pdf 2004-04-05 00:00:00
12090 2 019950 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,0200
90s031lbl.pdf 2010-08-10 00:00:00
12091 2 019950 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019950s056lbl.pdf
2011-06-06 00:00:00
12092 2 019950 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,0200
90s036lbl.pdf 2011-04-29 00:00:00
12093 2 019951 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19951s16lbl.pdf
2003-06-10 00:00:00
12094 2 019951 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr018_retrovir_lbl.p
df 2003-08-06 00:00:00
12095 2 019951 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf
2015-01-08 00:00:00
12096 2 019952 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019952s033lbl.pdf
2016-06-01 00:00:00
12097 2 019953 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf
2016-05-17 00:00:00
12098 2 019955 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,0199
55s010ltr.pdf 2005-11-16 00:00:00
12099 2 019957 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
2003-06-10 00:00:00
12100 2 019957 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf
2004-06-02 00:00:00
12101 14 019959 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12102 14 019959 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12103 14 019959 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12104 14 019959 SUPPL 73 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12105 14 019959 SUPPL 77 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12106 2 019962 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-
962S013_Toprol_prntlbl.pdf 2000-07-10 00:00:00
12107 2 019962 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf
2008-02-25 00:00:00
12108 2 019962 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf
2010-03-26 00:00:00
12109 2 019962 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf
2010-01-20 00:00:00
12110 2 019964 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
2003-03-20 00:00:00
12111 2 019964 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19
964slr021_terazol_lbl.pdf 2004-07-01 00:00:00
12113 2 019966 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019966s008lbl.pdf
2003-04-07 00:00:00
12114 2 019968 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf
2004-09-17 00:00:00
12115 2 019982 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019982s016lbl.pdf
2011-02-04 00:00:00
12116 2 019983 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19983s16lbl.pdf
2002-01-18 00:00:00
12117 14 019991 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12118 14 019991 SUPPL 36 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12119 14 019991 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12120 14 019991 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12121 14 019991 SUPPL 74 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12122 14 019991 SUPPL 77 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12123 2 019992 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf
2006-02-08 00:00:00
12124 2 020007 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf
2004-12-03 00:00:00
12125 2 020007 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20007s035lbl.pdf
2005-03-30 00:00:00
12126 2 020007 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.p
df 2006-01-05 00:00:00
12127 2 020007 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.p
df 2010-09-29 00:00:00
12128 2 020007 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.p
df 2011-09-16 00:00:00
12129 2 020007 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020007s043lbl.pdf
2012-11-15 00:00:00
12130 2 020007 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020007s046lbl.pdf
2014-09-22 00:00:00
12131 2 020010 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20010slr003_Lotrisone_lbl.
pdf 2003-04-04 00:00:00
12132 2 020010 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20010slr005_lotrisone_lbl.
pdf 2003-03-28 00:00:00
12133 2 020010 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020010s015lbl.pdf
2008-01-30 00:00:00
12134 2 020011 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20011s21lbl.pdf
2001-09-21 00:00:00
12135 2 020011 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.p
df 2009-06-04 00:00:00
12136 2 020011 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.p
df 2011-06-16 00:00:00
12137 2 020011 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf
2012-01-23 00:00:00
12138 2 020011 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020011s041lbl.pdf
2013-11-05 00:00:00
12139 2 020013 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20013s8lbl.pdf
2003-04-17 00:00:00
12140 2 020013 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20013slr014_mazaquin_lbl.p
df 2004-04-05 00:00:00
12141 2 020031 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031S26lbl.pdf
2001-04-13 00:00:00
12142 2 020031 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf
2005-01-13 00:00:00
12143 2 020031 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.p
df 2007-08-03 00:00:00
12144 2 020031 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf
2009-11-05 00:00:00
12145 2 020031 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,0207
10s024lbl.pdf 2008-11-07 00:00:00
12146 2 020031 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s
026s029s033,020936s040s043lbl.pdf 2011-03-28 00:00:00
12147 2 020031 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s
026s029s033,020936s040s043lbl.pdf 2011-03-28 00:00:00
12148 2 020031 SUPPL 71 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.p
df 2014-07-29 00:00:00
12149 2 020033 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf
2011-03-21 00:00:00
12150 2 020033 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf
2011-06-16 00:00:00
12151 2 020033 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf
2012-01-23 00:00:00
12152 2 020036 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf
2001-08-20 00:00:00
12153 2 020036 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf
2005-02-03 00:00:00
12154 2 020036 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf
2005-10-14 00:00:00
12155 2 020036 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf
2005-11-18 00:00:00
12156 2 020036 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf
2007-12-14 00:00:00
12157 2 020036 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf
2009-01-02 00:00:00
12158 2 020036 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf
2012-06-06 00:00:00
12159 2 020037 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf
2007-09-06 00:00:00
12160 2 020038 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020038s031lbl.pdf
2007-12-27 00:00:00
12161 2 020047 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf
2015-01-09 00:00:00
12162 2 020049 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-
S006_Pentasa_prntlbl.pdf 1999-09-10 00:00:00
12163 2 020049 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf
2013-12-17 00:00:00
12164 2 020059 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf
2014-01-07 00:00:00
12165 2 020062 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020062s040lbl.pdf
2010-11-22 00:00:00
12166 2 020065 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf
2007-08-02 00:00:00
12167 2 020066 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
066S010_Nicorette_prntlbl.pdf 2000-09-25 00:00:00
12168 2 020066 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.p
df 2012-03-28 00:00:00
12169 2 020066 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065,
020066Orig1s046lbl.pdf 2014-01-16 00:00:00
12170 2 020066 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig
1s049lbl.pdf 2013-11-07 00:00:00
12171 2 020066 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072,
s073, 020066Orig1s053, s054lbl .pdf 2014-08-05 00:00:00
12172 2 020067 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,1
8965s9,10,20067s4,6lbl.pdf 2004-11-16 00:00:00
12173 2 020067 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,0189
65s014,020067s011lbl.pdf 2006-01-25 00:00:00
12174 2 020067 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s
16,20067s14lbl.pdf 2007-09-26 00:00:00
12175 2 020067 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s
18,20067s17lbl.pdf 2008-07-29 00:00:00
12176 2 020067 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,0189
65s020,020067s018lbl.pdf 2013-03-26 00:00:00
12177 2 020068 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf
2015-05-05 00:00:00
12178 2 020071 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf
2007-06-12 00:00:00
12179 2 020073 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf
2007-10-10 00:00:00
12180 2 020075 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf
2011-11-16 00:00:00
12181 2 020076 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf
2002-07-15 00:00:00
12182 2 020076 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf
2014-07-29 00:00:00
12183 2 020076 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf
2016-06-17 00:00:00
12184 2 020076 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf
2016-07-08 00:00:00
12185 2 020076 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf
2016-07-18 00:00:00
12186 2 020080 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf
2006-02-07 00:00:00
12187 2 020080 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.
pdf 2012-10-04 00:00:00
12188 2 020080 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.
pdf 2012-10-04 00:00:00
12189 2 020080 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf
2015-06-12 00:00:00
12190 2 020083 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf
2002-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020083s053lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s035lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020123s037lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf
2011-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20164s055lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s093lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020165s024lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020165Orig1s029lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s034lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s036lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020180s026lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020180s044lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020184s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pd
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2008-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.p
df 2005-09-07 00:00:00
12323 2 020216 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf
2008-11-12 00:00:00
12324 2 020216 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf
2012-02-17 00:00:00
12325 2 020216 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf
2012-02-17 00:00:00
12326 2 020220 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf
2010-01-08 00:00:00
12327 2 020220 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf
2012-05-07 00:00:00
12328 2 020220 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.p
df 2015-07-09 00:00:00
12329 2 020221 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf
2008-11-12 00:00:00
12330 2 020222 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.p
df 2014-05-28 00:00:00
12332 2 020231 SUPPL 72 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072,
020231Orig1s073lbl.pdf 2014-08-05 00:00:00
12333 2 020231 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072,
020231Orig1s073lbl.pdf 2014-08-05 00:00:00
12334 2 020231 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020231Orig1s075lbl.pdf
2016-04-11 00:00:00
12335 2 020232 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf
2013-05-14 00:00:00
12336 2 020234 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/020234lbl.pdf 2004-
12-08 00:00:00
12337 2 020234 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,0189
27s035,020234s025REVISED_LABEL.pdf 2007-08-17 00:00:00
12338 2 020234 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,0189
27s038,020234s026lbl.pdf 2015-09-03 00:00:00
12339 2 020234 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020234s028lbl.pdf
2007-12-12 00:00:00
12340 2 020234 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
050,018927s041s042,020234s031s033lbl.pdf 2011-03-07 00:00:00
12341 2 020234 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
050,018927s041s042,020234s031s033lbl.pdf 2011-03-07 00:00:00
12342 2 020234 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,0189
27s048,020234s040lbl.pdf 2012-12-13 00:00:00
12343 2 020235 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf 2000-
10-12 00:00:00
12344 2 020235 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s
016lbl.pdf 2005-02-23 00:00:00
12345 2 020235 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,0211
29s022lbl.pdf 2011-03-04 00:00:00
12346 2 020235 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf
2010-10-11 00:00:00
12347 2 020235 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s
038s039s040,021129s035s036s037lbl.pdf 2013-05-09 00:00:00
12348 2 020235 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,0211
29s042lbl.pdf 2015-09-23 00:00:00
12349 2 020236 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20236slr028_serevent_lbl.p
df 2003-08-14 00:00:00
12350 2 020237 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf
2002-06-10 00:00:00
12351 2 020237 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020237s012lbl.pdf
2003-04-28 00:00:00
12352 2 020238 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020238s013lbl.pdf
2005-05-17 00:00:00
12353 2 020239 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20239s015lbl.pdf
2004-08-25 00:00:00
12354 2 020239 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020239s018lbl.pdf
2005-11-30 00:00:00
12355 2 020239 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,0212
38s007lbl.pdf 2009-10-14 00:00:00
12356 2 020239 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020239s023lbl.pdf
2011-05-02 00:00:00
12357 2 020241 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s2lbl.pdf
1998-08-24 00:00:00
12358 2 020241 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,0
20764SLRs3s14s18s19s20lbl.pdf 2006-09-26 00:00:00
12359 2 020241 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,0207
64s3s14s18s19s20lbl.pdf 2013-09-06 00:00:00
12360 2 020241 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,0207
64s3s14s18s19s20lbl.pdf 2013-09-06 00:00:00
12361 2 020241 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,0207
64s3s14s18s19s20lbl.pdf 2013-09-06 00:00:00
12362 2 020241 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s
033,022251s002s009lbl.pdf 2015-01-05 00:00:00
12363 2 020241 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s
031lbl.pdf 2009-05-12 00:00:00
12364 2 020241 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s
037,022251s005s006lbl.pdf 2010-10-28 00:00:00
12365 2 020241 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf
2015-03-25 00:00:00
12366 2 020241 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf
2015-03-25 00:00:00
12367 2 020241 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,0222
51s017lbl.pdf 2015-05-21 00:00:00
12368 2 020246 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020246s013lbl.pdf
2005-11-01 00:00:00
12369 2 020246 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20246scs019_Depo-
provera_lbl.pdf 2003-06-08 00:00:00
12370 2 020246 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20246s025lbl.pdf
2004-12-03 00:00:00
12371 2 020246 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020246s035lbl.pdf
2011-08-05 00:00:00
12372 2 020246 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s053lbl.pdf
2015-02-03 00:00:00
12373 2 020249 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf
2002-06-06 00:00:00
12374 2 020250 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf
2002-08-01 00:00:00
12375 2 020251 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,0202
51s019lbl.pdf 2009-10-06 00:00:00
12376 2 020254 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf
2011-03-04 00:00:00
12377 2 020255 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020255s016lbl.pdf
2013-04-19 00:00:00
12378 2 020258 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20258slr019_iopidine_lbl.p
df 2004-06-18 00:00:00
12379 2 020261 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
192_Lescol_Prntlbl.pdf 2004-06-08 00:00:00
12380 2 020261 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf
2002-09-06 00:00:00
12381 2 020261 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf
2005-01-11 00:00:00
12382 2 020261 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035
,s036lbl.pdf 2006-04-12 00:00:00
12383 2 020261 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.p
df 2006-04-05 00:00:00
12384 2 020261 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.p
df 2007-06-14 00:00:00
12385 2 020261 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s046lbl.pdf
2012-02-28 00:00:00
12386 2 020262 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262s24lbl.pdf
1998-06-30 00:00:00
12387 2 020262 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf 1998-
04-09 00:00:00
12388 2 020262 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf 1998-
04-09 00:00:00
12389 2 020262 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20262S33LBL.PDF
1999-10-25 00:00:00
12390 2 020262 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf
2010-08-28 00:00:00
12391 2 020262 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf
2015-03-05 00:00:00
12392 2 020263 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf
2004-04-05 00:00:00
12393 2 020263 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf
2005-11-17 00:00:00
12394 2 020263 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf
2009-06-29 00:00:00
12395 2 020272 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf
2004-06-16 00:00:00
12396 2 020272 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-
17,18,21444s-2,3_risperdal_lbl.pdf 2003-12-11 00:00:00
12397 2 020272 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s
028s029,020272s036s041lbl.pdf 2006-10-11 00:00:00
12398 2 020272 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s
028s029,020272s036s041lbl.pdf 2006-10-11 00:00:00
12399 2 020272 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,0214
44s016,021346s010lbl.pdf 2005-08-19 00:00:00
12400 2 020272 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,2
1444s20s21lbl.pdf 2007-08-23 00:00:00
12401 2 020272 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,2
1444s20s21lbl.pdf 2007-08-23 00:00:00
12402 2 020272 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-
061S-062lbl.pdf 2010-08-30 00:00:00
12403 2 020272 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,0213
46s033,021444s03lbl.pdf 2009-08-06 00:00:00
12404 2 020272 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-
061S-062lbl.pdf 2010-08-30 00:00:00
12405 2 020272 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,0214
44s034lbl.pdf 2011-08-25 00:00:00
12406 2 020272 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,0213
46s040,021444s039lbl.pdf 2010-12-04 00:00:00
12407 2 020272 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,0214
44s040lbl.pdf 2011-06-16 00:00:00
12408 2 020272 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,0214
44s041lbl.pdf 2012-08-03 00:00:00
12409 2 020273 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,0202
73s009lbl.pdf 2007-10-04 00:00:00
12410 2 020273 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.p
df 2015-03-17 00:00:00
12411 2 020279 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020279s009lbl.pdf
2010-12-06 00:00:00
12412 14 020280 SUPPL 40 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12413 14 020280 SUPPL 55 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12414 14 020280 SUPPL 60 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12415 14 020280 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12416 14 020280 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12417 14 020280 SUPPL 77 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12418 14 020280 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12419 2 020281 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf
2009-10-06 00:00:00
12420 2 020287 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s062lbl.pdf
2015-01-30 00:00:00
12421 2 020291 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf
2009-05-11 00:00:00
12422 2 020297 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf
2005-05-02 00:00:00
12423 2 020297 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf
2006-08-29 00:00:00
12424 2 020297 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf
2007-02-26 00:00:00
12425 2 020297 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf
2011-01-31 00:00:00
12426 2 020298 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf
2016-04-04 00:00:00
12427 2 020301 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf
2013-10-04 00:00:00
12428 2 020301 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf
2012-07-13 00:00:00
12429 2 020301 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf
2015-12-02 00:00:00
12430 1 020304 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf
2020-03-23 00:00:00
12431 2 020304 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf
2020-03-23 00:00:00
12432 2 020304 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s022lbl.pdf
2020-03-23 00:00:00
12433 2 020305 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,0212
38s007lbl.pdf 2009-10-14 00:00:00
12434 2 020306 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_prntlb
l.pdf 2004-03-10 00:00:00
12435 2 020312 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf
2010-01-29 00:00:00
12436 2 020312 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf
2011-09-02 00:00:00
12437 2 020312 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf
2012-01-23 00:00:00
12438 2 020312 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf
2012-09-18 00:00:00
12439 2 020313 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020313s034lbl.pdf
2014-03-13 00:00:00
12440 2 020316 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf
2015-07-23 00:00:00
12441 2 020323 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf
2000-08-16 00:00:00
12442 2 020325 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-
015_pepcid_lbl.pdf 2003-09-30 00:00:00
12443 2 020325 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf
2016-04-11 00:00:00
12444 2 020325 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf
2016-06-13 00:00:00
12445 2 020326 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf
2002-06-26 00:00:00
12446 2 020326 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020326s015lbl.pdf
2005-11-17 00:00:00
12447 2 020327 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf
2012-08-02 00:00:00
12448 2 020329 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20329s2lbl.pdf
2002-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020329s22lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020329s025lbl.pdf
2011-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020329s028lbl.pdf
2013-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020329s029lbl.pdf
2015-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf
2004-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020330s029lbl.pdf
2015-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf
1998-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf
2004-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf
2008-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf
2011-01-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf
2011-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf
2014-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf
2015-07-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20334slr003_flagyl_lbl.pdf
2004-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020337s005lbl.pdf
2003-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020355s007lbl.pdf
2007-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s017lbl.pdf
2013-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20358s27lbl.pdf
2002-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020358s043lbl.pdf
2007-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf
2013-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020358s056lbl.pdf
2014-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20363S19LBL.PDF
2001-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf
2006-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020363s036lbl.pdf
2010-01-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf
2012-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf
2013-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020364-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020364s023lbl.pdf
2006-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20364slr024_lotrel_lbl.pdf
2004-07-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020364s039lbl.pdf
2007-09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s046lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s050lbl.pdf
2011-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s054lbl.pdf
2011-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf
2012-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s060lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367slr055_Cerezyme_lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20369lbl.pdf 1998-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf
2003-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf
2004-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf
2003-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf
1999-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf
2004-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf
2005-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf
2006-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020379s030lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf
2009-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf
2010-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf
2010-11-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf
2002-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf
2003-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s033lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s037lbl.pdf
2005-10-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s041lbl.pdf
2006-08-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020387s048lbl.pdf
2010-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s052lbl.pdf
2011-08-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s055lbl.pdf
2011-08-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf
2012-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020387s057lbl.pdf
2013-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20393slr004,20394slr005_at
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20402S5LBL.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf
2004-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s47lbl.pdf
2002-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408s23lbl.pdf
2002-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20408se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020408s047lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020408s050lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020411s027lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031,
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020415s032lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20428slr016_azelex_lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020438s006lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020441s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020448s004lbl.pdf
2007-01-16 00:00:00
12583 2 020449 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-
018_Taxotere_lbl.pdf 2002-11-27 00:00:00
12584 2 020449 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.p
df 2004-06-18 00:00:00
12585 2 020449 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf
2004-05-19 00:00:00
12586 2 020449 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf
2006-04-05 00:00:00
12587 2 020449 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf
2006-10-18 00:00:00
12588 2 020449 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf
2010-05-03 00:00:00
12589 2 020449 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf
2007-10-04 00:00:00
12590 2 020449 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf
2010-05-03 00:00:00
12591 2 020449 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf
2015-04-14 00:00:00
12592 2 020449 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf
2011-09-16 00:00:00
12593 2 020449 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf
2013-07-08 00:00:00
12594 2 020449 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf
2013-12-17 00:00:00
12595 2 020449 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf
2014-11-20 00:00:00
12596 2 020449 SUPPL 75 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf
2015-12-15 00:00:00
12597 2 020450 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf
2001-08-31 00:00:00
12598 2 020450 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.
pdf 2011-11-16 00:00:00
12599 2 020450 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.
pdf 2011-11-16 00:00:00
12600 2 020450 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s023lbl.pdf
2014-01-07 00:00:00
12601 2 020450 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s025lbl.pdf
2014-06-17 00:00:00
12602 2 020451 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pd
f 2003-08-14 00:00:00
12603 2 020451 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s020lbl.pdf
2011-04-04 00:00:00
12604 2 020452 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
452.pdf_Paraplatin_Prntlbl.pdf 2004-06-14 00:00:00
12605 2 020452 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20452scs001_paraplatin_lbl
.pdf 2004-01-15 00:00:00
12606 2 020452 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020452s005lbl.pdf
2015-11-02 00:00:00
12607 2 020457 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf
2011-03-21 00:00:00
12608 2 020468 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr011_nasacort_lbl.p
df 2003-12-29 00:00:00
12609 2 020468 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20468slr013_nasacort_lbl.p
df 2004-04-05 00:00:00
12610 2 020468 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020468s024lbl.pdf
2008-09-25 00:00:00
12611 2 020468 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf
2013-07-03 00:00:00
12612 2 020468 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468Orig1s035lbl.pdf
2013-10-15 00:00:00
12613 2 020468 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020468Orig1s040lbl.pdf
2015-06-22 00:00:00
12614 2 020470 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf
2004-08-02 00:00:00
12615 2 020471 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020471s011lbl.pdf
2005-09-30 00:00:00
12616 2 020471 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020471s017lbl.pdf
2012-06-18 00:00:00
12617 2 020472 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf
2015-12-10 00:00:00
12618 2 020474 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20474slr016_vexol_lbl.pdf
2003-05-29 00:00:00
12619 2 020475 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf
2014-01-31 00:00:00
12620 2 020478 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20478S6LBL.PDF
2001-03-30 00:00:00
12621 2 020478 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf
2012-08-17 00:00:00
12622 2 020478 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf
2012-08-17 00:00:00
12623 2 020478 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf
2014-03-13 00:00:00
12624 2 020484 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf 2000-
07-14 00:00:00
12625 2 020484 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020484s013lbl.pdf
2009-12-30 00:00:00
12626 2 020484 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf
2010-10-12 00:00:00
12627 2 020485 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf
2002-06-14 00:00:00
12628 2 020485 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf
2014-01-14 00:00:00
12629 2 020487 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf
2005-11-30 00:00:00
12630 2 020487 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf
2007-12-14 00:00:00
12631 2 020489 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf
2011-10-25 00:00:00
12632 2 020489 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf
2015-05-13 00:00:00
12633 2 020490 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf
2001-12-20 00:00:00
12634 2 020491 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf 2001-
04-20 00:00:00
12635 2 020496 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
2009-02-04 00:00:00
12636 2 020496 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf
2013-08-09 00:00:00
12637 2 020496 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf
2013-10-22 00:00:00
12638 2 020497 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020497s006lbl.pdf
2011-03-28 00:00:00
12639 2 020498 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf
2005-05-17 00:00:00
12640 2 020498 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf
2006-03-14 00:00:00
12641 2 020498 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf
2009-02-12 00:00:00
12642 2 020500 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF
2004-06-09 00:00:00
12643 2 020500 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf
2013-03-05 00:00:00
12644 2 020500 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf
2015-06-10 00:00:00
12645 2 020505 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-
014,20505s010,19s2-017_Topamax_lbl.pdf 2003-12-29 00:00:00
12646 2 020505 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,02
1lbl.pdf 2004-08-12 00:00:00
12647 2 020505 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,02
1lbl.pdf 2004-08-12 00:00:00
12648 2 020505 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020
844s011s026s027s031lbl.pdf 2010-01-04 00:00:00
12649 2 020505 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s
034lbl.pdf 2009-05-12 00:00:00
12650 2 020505 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s
037lbl.pdf 2011-03-04 00:00:00
12651 2 020505 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.p
df 2011-07-18 00:00:00
12652 2 020505 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s
037lbl.pdf 2011-03-04 00:00:00
12653 2 020505 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.p
df 2014-01-31 00:00:00
12654 2 020505 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.p
df 2014-12-19 00:00:00
12655 2 020508 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20508s006lbl.pdf
2004-12-30 00:00:00
12656 2 020509 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf
2003-03-07 00:00:00
12657 2 020509 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf
2004-05-19 00:00:00
12658 2 020509 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf
2005-04-28 00:00:00
12659 2 020509 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf
2010-03-26 00:00:00
12660 2 020509 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf
2011-02-09 00:00:00
12661 2 020509 SUPPL 75 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf
2015-10-13 00:00:00
12662 2 020511 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20511s002lbl.pdf
2002-06-11 00:00:00
12663 2 020516 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-
603S002_Ibuprofen_prntlbl.pdf 1999-09-13 00:00:00
12664 2 020516 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf
2015-04-21 00:00:00
12665 2 020517 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s
036,020517s024s028s029lbl.pdf 2010-05-07 00:00:00
12666 2 020517 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s
036,020517s024s028s029lbl.pdf 2010-05-07 00:00:00
12667 2 020517 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s031lbl.pdf
2011-01-20 00:00:00
12668 2 020517 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf
2011-06-28 00:00:00
12669 2 020517 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020517s033lbl.pdf
2012-07-19 00:00:00
12670 2 020517 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.p
df 2013-07-11 00:00:00
12671 2 020517 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.p
df 2016-06-13 00:00:00
12672 2 020518 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518
s13lbl.pdf 2006-05-16 00:00:00
12673 2 020518 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,0205
18s016lbl.pdf 2008-09-25 00:00:00
12674 2 020518 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.p
df 2009-11-23 00:00:00
12675 2 020519 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,0205
19s016lbl.pdf 2013-07-11 00:00:00
12676 2 020520 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf
2015-11-25 00:00:00
12677 14 020522 SUPPL 13 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12678 14 020522 SUPPL 21 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12679 14 020522 SUPPL 36 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12680 14 020522 SUPPL 51 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12681 2 020527 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527s30bl.pdf
2003-01-07 00:00:00
12682 2 020527 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf
2004-12-29 00:00:00
12683 2 020527 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020527s036lbl.pdf
2005-07-07 00:00:00
12684 2 020527 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020527s043lbl.pdf
2008-03-05 00:00:00
12685 2 020527 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s046lbl.pdf
2009-06-05 00:00:00
12686 2 020527 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.
pdf 2012-02-06 00:00:00
12687 2 020528 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf
2012-01-23 00:00:00
12688 2 020528 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.p
df 2012-03-06 00:00:00
12689 2 020528 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf
2016-02-02 00:00:00
12690 2 020533 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20533s012lbl.pdf
2004-08-12 00:00:00
12691 2 020533 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf
2010-02-25 00:00:00
12692 2 020538 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf
1999-01-08 00:00:00
12693 2 020538 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pd
f 2004-02-03 00:00:00
12694 2 020538 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf
2004-08-10 00:00:00
12695 2 020538 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf
2013-05-21 00:00:00
12696 2 020538 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf
2014-08-01 00:00:00
12697 2 020539 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf
2013-10-25 00:00:00
12698 2 020541 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
541S006_Arimidex_prntlbl.pdf 2000-09-01 00:00:00
12699 2 020541 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf
2002-09-05 00:00:00
12700 2 020541 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf
2005-09-22 00:00:00
12701 2 020541 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf
2009-01-02 00:00:00
12702 2 020541 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf
2009-05-11 00:00:00
12703 2 020541 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf
2009-05-11 00:00:00
12704 2 020541 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf
2013-05-09 00:00:00
12705 2 020541 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf
2014-05-06 00:00:00
12706 2 020544 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20544se2-
003_jadelle_lbl.pdf 2002-11-22 00:00:00
12707 2 020547 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf
2009-08-28 00:00:00
12708 2 020547 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf
2010-07-19 00:00:00
12709 2 020547 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf
2011-08-08 00:00:00
12710 2 020548 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pd
f 2003-10-16 00:00:00
12711 2 020548 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_fl
ovent_lbl.pdf 2004-04-05 00:00:00
12712 2 020549 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr014_flovent_lbl.pd
f 2003-10-16 00:00:00
12713 2 020550 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s005lbl.pdf
2003-04-01 00:00:00
12714 2 020550 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf
2003-04-25 00:00:00
12715 2 020550 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s12lbl.pdf
2003-04-25 00:00:00
12716 2 020550 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf
2003-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020552s005lbl.pdf
2009-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020552s007lbl.pdf
2011-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-
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12720 2 020560 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_prntlbl.pdf
1999-06-08 00:00:00
12721 2 020560 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf
2000-10-20 00:00:00
12722 2 020560 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fo
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12723 2 020560 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-
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12724 2 020560 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fo
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12725 2 020560 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,00
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12726 2 020560 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.p
df 2005-11-03 00:00:00
12727 2 020560 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,
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12728 2 020560 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s056lbl.pdf
2012-02-06 00:00:00
12730 2 020560 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.p
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12731 2 020563 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-
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12733 2 020563 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pd
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12734 2 020563 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-
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12735 2 020563 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf
2020-03-23 00:00:00
12736 1 020563 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm041ltr.pdf
2020-03-23 00:00:00
12737 2 020563 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pd
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12738 2 020563 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,0210
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020563Orig1s123ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s124ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s163ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf
2002-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_ep
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12748 2 020564 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf
2004-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20571s8lbl.pdf
1998-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20571s16lbl.pdf
2002-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s026lbl.pdf
2005-06-08 00:00:00
12752 2 020571 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf
2005-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037
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12754 2 020571 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037
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12755 2 020571 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037
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12756 2 020571 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf
2015-01-09 00:00:00
12757 2 020572 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.p
df 2009-04-03 00:00:00
12758 2 020573 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.p
df 2009-04-03 00:00:00
12759 2 020576 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf
2010-04-05 00:00:00
12760 2 020578 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf
1998-07-27 00:00:00
12761 2 020578 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf
2009-09-17 00:00:00
12762 2 020578 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020578s032lbl.pdf
2011-01-20 00:00:00
12763 2 020578 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.p
df 2013-06-17 00:00:00
12764 2 020578 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.p
df 2013-06-17 00:00:00
12765 2 020578 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.p
df 2014-10-09 00:00:00
12766 2 020579 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf
2007-01-16 00:00:00
12767 2 020579 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf
2007-02-21 00:00:00
12768 2 020579 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf
2009-10-30 00:00:00
12769 2 020579 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf
2010-01-04 00:00:00
12770 2 020579 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf
2011-07-27 00:00:00
12771 2 020582 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf
2020-03-23 00:00:00
12772 2 020584 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
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12773 2 020584 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf
2005-05-26 00:00:00
12774 2 020588 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-
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12775 2 020588 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s
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12776 2 020588 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,2
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12777 2 020588 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,2
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12778 2 020588 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,0213
46s033,021444s03lbl.pdf 2009-08-06 00:00:00
12779 2 020588 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,0214
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12780 2 020588 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-
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12781 2 020588 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,0213
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12782 2 020588 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s
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12783 2 020588 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,0214
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12784 2 020589 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf
2003-04-25 00:00:00
12785 2 020589 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf
2014-01-13 00:00:00
12786 2 020591 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf
2011-08-29 00:00:00
12787 2 020591 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.p
df 2012-01-23 00:00:00
12788 2 020591 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf
2015-01-08 00:00:00
12789 2 020591 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s027lbl.pdf
2016-07-13 00:00:00
12790 2 020592 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20592se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s
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12792 2 020592 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s
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12793 2 020592 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf
2009-12-10 00:00:00
12794 2 020592 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf
2009-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s
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12796 2 020592 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s
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12797 2 020592 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,0212
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12798 2 020592 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s
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12799 2 020592 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253
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12800 2 020592 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.p
df 2013-07-30 00:00:00
12801 2 020593 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20593s006lbl.pdf
2002-01-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020593s019lbl.pdf
2014-06-23 00:00:00
12804 2 020593 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf
2011-10-12 00:00:00
12805 2 020593 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf
2011-10-07 00:00:00
12806 2 020593 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s029lbl.pdf
2015-01-08 00:00:00
12807 2 020593 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,0187
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12808 2 020593 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s033lbl.pdf
2015-10-06 00:00:00
12809 2 020596 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf
2004-12-03 00:00:00
12810 2 020596 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.p
df 2011-12-02 00:00:00
12811 2 020596 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.p
df 2015-02-20 00:00:00
12812 2 020597 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597SE1-
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12813 2 020597 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s19lbl.pdf
2003-04-28 00:00:00
12814 2 020597 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s23lbl.pdf
2003-04-28 00:00:00
12815 2 020597 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597s25lbl.pdf
2002-08-26 00:00:00
12816 2 020597 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf
2010-09-07 00:00:00
12817 2 020597 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf
2014-12-03 00:00:00
12818 2 020597 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020597s046lbl.pdf
2013-03-15 00:00:00
12819 2 020599 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf
2009-07-23 00:00:00
12820 2 020599 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s013lbl.pdf
2009-11-17 00:00:00
12821 2 020600 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020600s008lbl.pdf
2011-03-04 00:00:00
12822 2 020603 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-
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12823 2 020603 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf
2002-01-16 00:00:00
12824 14 020604 SUPPL 29 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12825 14 020604 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12826 14 020604 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12827 14 020604 SUPPL 40 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12828 14 020604 SUPPL 44 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12829 14 020604 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
12830 2 020605 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF
2000-12-13 00:00:00
12831 2 020605 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s
007lbl.pdf 2004-12-03 00:00:00
12832 2 020605 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008l
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12833 2 020605 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781
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12834 2 020605 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,0207
81s013lbl.pdf 2010-09-29 00:00:00
12835 2 020605 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,0207
81s014lbl.pdf 2011-09-16 00:00:00
12836 2 020605 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,0207
81s015lbl.pdf 2013-12-11 00:00:00
12837 2 020607 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020607s009lbl.pdf
2006-01-25 00:00:00
12838 2 020607 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020607s010lbl.pdf
2007-08-27 00:00:00
12839 2 020607 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s013lbl.pdf
2009-10-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020607s028lbl.pdf
2014-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020607s031lbl.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.p
df 2015-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s014lbl.pdf
2006-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020610s017lbl.pdf
2007-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020611s006lbl.pdf
2005-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,0202
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020612s008lbl.pdf
2006-05-01 00:00:00
12848 2 020612 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf
2015-01-08 00:00:00
12849 2 020613 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020613s031lbl.pdf
2016-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020615s002lbl.pdf
2009-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020615s003lbl.pdf
2010-08-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020616s010lbl.pdf
2005-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf
2007-03-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf
2007-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf
2009-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s089lbl.pdf
2014-01-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020623s008lbl.pdf
2009-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020623s012lbl.pdf
2014-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020624s013lbl.pdf
2005-06-07 00:00:00
12861 2 020624 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf 2003-
04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf
2004-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf
2010-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf
2012-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20628s16lbl.pdf
2002-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020629s016lbl.pdf
2013-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20630se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf
2004-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf
2009-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf
2000-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf
2001-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,03
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf
2000-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_le
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,03
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,03
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,0217
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12897 2 020635 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,0217
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12898 2 020635 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_02063
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20636slr022_viramune_lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.p
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12904 2 020636 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.p
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12905 2 020636 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.p
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12906 2 020636 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s023lbl.pdf
2006-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s026lbl.pdf
2006-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf
2009-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020639s052lbl.pdf
2010-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf
2013-10-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf
2016-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf
2000-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf
2015-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf
2016-01-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf
2015-11-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf
2016-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020649s015lbl.pdf
2006-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf
2003-12-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf
2002-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.
pdf 2009-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020657s024lbl.pdf
2010-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s025lbl.pdf
2011-01-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s026lbl.pdf
2011-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s027lbl.pdf
2012-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s028lbl.pdf
2012-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020658s013lbl.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf
2009-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf
2003-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_no
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s045lbl.pdf
2010-02-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.p
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12945 2 020659 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s007lbl.pdf
2007-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s011lbl.pdf
2011-07-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s012lbl.pdf
2011-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf
2014-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf
2014-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020665s038lbl.pdf
2015-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf
2015-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf
2006-11-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
2009-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015230s037ltr.pdf
2009-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/015296Orig1s064ltr.pdf
2012-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s080,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s082,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/015923Orig1s089,018701
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016042s077ltr.pdf
2010-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016042s078ltr.pdf
2011-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17118slr017ltr.pdf
2003-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017118s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017243s028ltr.pdf
2006-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017243Orig1s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17279s8ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17284slr009LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017284s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17351slr030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017376Orig1s060ltr.pdf
2013-09-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17377scf058ltr.pdf
2002-10-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s066ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s067ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017377Orig1s074ltr.pdf
2014-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017451s060,017378s065l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017378Orig1s068,017385
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17381slr041ltr.pdf
2004-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017378Orig1s068,017385
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017385Orig1s060ltr.pdf
2014-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016324Orig1s037,017391
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17398scm014ltr.pdf
2003-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17398s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017407s037ltr.pdf
2012-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017422s037ltr.pdf
2007-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s042ltr.pdf
2011-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.p
df 2004-09-10 00:00:00
13136 1 017441 SUPPL 161 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17441S161ltr.pdf
2001-04-18 00:00:00
13137 1 017442 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s033ltr.pdf
2009-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s035ltr.pdf
2009-07-15 00:00:00
13139 1 017442 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017442Orig1s041ltr.pdf
2013-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf
2015-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s
048,s049ltr.pdf 2012-07-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s
048,s049ltr.pdf 2012-07-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17450scp052ltr.pdf
2002-08-07 00:00:00
13144 1 017451 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017451s060,017378s065l
tr.pdf 2009-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17453scm010ltr.pdf
2004-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017463s104ltr.pdf
2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17468slr019,17469slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017469s035LTR.pdf
2006-05-18 00:00:00
13149 1 017473 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17473slr038ltr.pdf
2002-11-14 00:00:00
13150 1 017473 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017473s043ltr.pdf
2009-07-23 00:00:00
13151 1 017473 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017473s045ltr.pdf
2010-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017473s046ltr.pdf
2011-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17476s044,045ltr.pdf
2004-12-02 00:00:00
13154 1 017478 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17478scs013ltr.pdf
2004-03-10 00:00:00
13155 1 017493 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493slr066ltr.pdf
2003-05-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017498s027ltr.pdf
2008-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017498s029ltr.pdf
2009-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017498s030ltr.pdf
2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017498Orig1s031ltr.pdf
2013-10-16 00:00:00
13160 1 017512 SUPPL 108 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017512s108ltr.pdf
2008-12-24 00:00:00
13161 1 017512 SUPPL 118 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s120,s121lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17514slr058ltr.pdf
2004-04-29 00:00:00
13164 1 017516 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016798Orig1s056,017516
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf
2003-07-31 00:00:00
13166 1 017522 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
2002-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
2002-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17529s009ltr.pdf
2004-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
2009-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024
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2011-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf
2015-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020668s005lbl.pdf
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20668slr011_lexxel_lbl.pdf
2004-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf
2007-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20671s4lbl.pdf
1998-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020671s014lbl.pdf
2006-06-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf
2010-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020671s020lbl.pdf
2014-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020675s013lbl.pdf
2008-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020675s017lbl.pdf
2009-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020676Orig1s009lbl.pdf
2014-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020677s006lbl.pdf
2003-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf
2012-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf
2008-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf
2008-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_l
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_l
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s55lbl.pdf
2002-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685s060lbl.pdf
2004-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s061lbl.pdf
2006-01-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s062lbl.pdf
2006-08-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s063lbl.pdf
2006-12-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020685s064lbl.pdf
2007-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s066lbl.pdf
2008-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020685s069lbl.pdf
2009-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s071lbl.pdf
2010-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s073lbl.pdf
2010-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf
2012-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf 2000-
09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf
2005-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf
2011-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20688slr016_patanol_lbl.pd
f 2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,0217
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,0225
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf
1998-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20692s16lbl.pdf
2002-03-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20692slr024_serevent_lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020692s029lbl.pdf
2006-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s032lbl.pdf
2011-01-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020697s010lbl.pdf
2006-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020697s012lbl.pdf
2007-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf
2009-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf
2009-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20699s1lbl.pdf
1999-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf
2003-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020699s022lbl.pdf
2003-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020699s047lbl.pdf
2007-12-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf
2005-11-22 00:00:00
13229 2 020699 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf
2005-11-22 00:00:00
13230 2 020699 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s059lbl.pdf
2005-12-05 00:00:00
13231 2 020699 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.p
df 2006-10-23 00:00:00
13232 2 020699 SUPPL 83 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.p
df 2008-02-14 00:00:00
13233 2 020699 SUPPL 89 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf
2012-09-11 00:00:00
13234 2 020699 SUPPL 91 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s091lbl.pdf
2014-12-19 00:00:00
13235 2 020699 SUPPL 99 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf
2012-12-28 00:00:00
13236 2 020699 SUPPL 100 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.p
df 2012-05-07 00:00:00
13237 2 020699 SUPPL 102 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf
2012-12-28 00:00:00
13238 2 020699 SUPPL 103 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf
2014-07-08 00:00:00
13239 2 020699 SUPPL 106 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020699s106lbl.pdf
2016-03-03 00:00:00
13240 2 020701 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20701s014lbl.pdf
2005-03-29 00:00:00
13241 2 020701 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf
2011-12-14 00:00:00
13242 2 020701 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020701s026lbl.pdf
2013-08-22 00:00:00
13243 2 020702 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20702s25lbl.pdf
2001-06-15 00:00:00
13244 2 020702 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s33lbl.pdf
2002-10-18 00:00:00
13245 2 020702 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf
2004-06-08 00:00:00
13246 2 020702 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702slr036_lipitor_lbl.pd
f 2003-05-29 00:00:00
13247 2 020702 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702scs037_lipitor_lbl.pd
f 2003-10-10 00:00:00
13248 2 020702 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s047lbl.pdf
2007-03-07 00:00:00
13249 2 020702 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf
2012-11-02 00:00:00
13250 2 020704 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013,
020704Orig1s028lbl.pdf 2015-12-01 00:00:00
13251 2 020705 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20705s03lbl.pdf
1999-07-14 00:00:00
13252 2 020705 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20705S8lbl.pdf
2003-04-22 00:00:00
13253 2 020705 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020705s018lbl.pdf
2012-08-15 00:00:00
13254 2 020706 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pd
f 2003-05-29 00:00:00
13255 2 020707 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020707s005lbl.pdf
2006-11-22 00:00:00
13256 2 020708 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
708S011_Lupron_prntlbl.pdf 2001-09-21 00:00:00
13257 2 020708 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.pdf
2013-11-05 00:00:00
13258 2 020710 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s
030lbl.pdf 2011-07-12 00:00:00
13259 2 020710 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s
030lbl.pdf 2011-07-12 00:00:00
13260 2 020710 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf
2012-12-31 00:00:00
13261 2 020710 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s
026s029s033,020936s040s043lbl.pdf 2011-03-28 00:00:00
13262 2 020710 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.p
df 2014-07-29 00:00:00
13263 2 020711 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zy
ban_lbl.pdf 2004-07-01 00:00:00
13264 2 020711 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf
2004-11-08 00:00:00
13265 2 020711 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s
009,20711s021lbl.pdf 2005-01-13 00:00:00
13266 2 020711 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020711s027lbl.pdf
2006-11-22 00:00:00
13267 2 020711 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s028lbl.pdf
2007-03-23 00:00:00
13268 2 020711 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s029lbl.pdf
2007-08-03 00:00:00
13269 2 020711 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf
2009-07-09 00:00:00
13270 2 020711 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf
2009-07-09 00:00:00
13271 2 020711 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s035lbl.pdf
2011-08-22 00:00:00
13272 2 020711 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s039lbl.pdf
2014-04-01 00:00:00
13273 2 020711 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s042lbl.pdf
2015-01-09 00:00:00
13274 2 020712 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020712s025lbl.pdf
2006-07-03 00:00:00
13275 2 020712 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020712s029lbl.pdf
2007-12-12 00:00:00
13276 2 020712 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020712s030lbl.pdf
2009-04-28 00:00:00
13277 2 020713 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf
2012-07-19 00:00:00
13278 2 020715 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,0224
37s007lbl.pdf 2013-03-15 00:00:00
13279 2 020715 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,0224
37s008lbl.pdf 2014-07-15 00:00:00
13280 2 020717 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20717lbl.pdf 1998-
12-24 00:00:00
13281 2 020717 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20717se1-
008_provigil_lbl.pdf 2004-02-03 00:00:00
13282 2 020717 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
2007-08-21 00:00:00
13283 2 020717 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
2010-10-25 00:00:00
13284 2 020717 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
2010-10-25 00:00:00
13285 2 020717 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf
2015-01-20 00:00:00
13286 2 020720 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20720s12lbl.pdf
1999-06-16 00:00:00
13287 2 020723 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf
2004-05-26 00:00:00
13288 2 020723 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf
2004-07-21 00:00:00
13289 2 020723 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020723s018lbl.pdf
2005-08-11 00:00:00
13290 14 020725 SUPPL 6 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13291 14 020725 SUPPL 8 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13292 14 020725 SUPPL 11 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13293 14 020725 SUPPL 14 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13294 2 020726 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s005lbl.pdf
2003-03-04 00:00:00
13295 2 020726 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20726S006LBL.PDF
2001-01-10 00:00:00
13296 2 020726 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s008lbl.pdf
2003-01-17 00:00:00
13297 2 020726 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020726s011lbl.pdf
2004-10-29 00:00:00
13298 2 020726 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf
2010-03-03 00:00:00
13299 2 020726 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf
2010-03-03 00:00:00
13300 2 020726 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s019lbl.pdf
2010-07-01 00:00:00
13301 2 020726 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s020lbl.pdf
2010-05-06 00:00:00
13302 2 020726 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020726s027lbl.pdf
2014-01-16 00:00:00
13303 2 020727 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020727s004lbl.pdf
2013-04-01 00:00:00
13304 2 020727 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020727s005lbl.pdf
2015-04-07 00:00:00
13305 2 020729 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s024lbl.pdf
2011-09-02 00:00:00
13306 2 020732 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf
2002-10-08 00:00:00
13307 2 020732 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf
2011-12-23 00:00:00
13308 2 020732 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020732Orig1s010lbl.pdf
2014-12-18 00:00:00
13309 2 020733 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf
2002-10-08 00:00:00
13310 2 020733 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf
2011-12-23 00:00:00
13311 2 020733 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020733Orig1s014lbl.pdf
2014-12-18 00:00:00
13312 2 020738 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_PRNTLBL.PDF
2004-06-18 00:00:00
13313 2 020738 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020738s026lbl.pdf
2011-05-05 00:00:00
13314 2 020738 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s027lbl.pdf
2012-01-23 00:00:00
13315 2 020738 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s028lbl.pdf
2012-09-14 00:00:00
13316 2 020740 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.cfm
2010-03-02 00:00:00
13317 2 020740 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
740S008_Baycol_prntlbl.pdf 2000-07-21 00:00:00
13318 2 020740 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
740S008_Baycol_prntlbl.pdf 2000-07-21 00:00:00
13319 2 020741 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf
2002-01-18 00:00:00
13320 2 020741 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf
2002-10-21 00:00:00
13321 2 020741 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pd
f 2003-08-29 00:00:00
13322 2 020741 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf
2005-02-11 00:00:00
13323 2 020741 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf
2008-07-15 00:00:00
13324 2 020741 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf
2010-07-31 00:00:00
13325 2 020741 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf
2012-03-06 00:00:00
13326 2 020742 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.p
df 2003-07-10 00:00:00
13327 2 020742 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl
.pdf 2004-05-27 00:00:00
13328 2 020742 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf
2004-10-04 00:00:00
13329 2 020743 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020743s002lbl.pdf
2003-04-04 00:00:00
13330 2 020746 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20
929slr015_pulmicort_lbl.pdf 2003-09-30 00:00:00
13331 2 020746 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020746s021lbl.pdf
2007-10-22 00:00:00
13332 2 020746 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020746s024lbl.pdf
2009-05-25 00:00:00
13333 2 020746 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf
2010-12-28 00:00:00
13334 2 020746 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020746Orig1s032.pdf
2015-03-25 00:00:00
13335 2 020747 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf 1998-
11-04 00:00:00
13336 2 020747 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf
2004-09-29 00:00:00
13337 2 020747 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf
2007-02-21 00:00:00
13338 2 020747 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf
2011-07-21 00:00:00
13339 2 020747 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf
2009-11-13 00:00:00
13340 2 020747 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf
2012-06-11 00:00:00
13341 2 020753 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20753LBL.PDF 1999-
10-21 00:00:00
13342 2 020753 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20753slr003_aromasin_lbl.p
df 2003-12-02 00:00:00
13343 2 020753 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20753s005lbl.pdf
2004-09-29 00:00:00
13344 2 020753 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020753s006lbl.pdf
2005-10-07 00:00:00
13345 2 020753 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf
2011-03-28 00:00:00
13346 2 020753 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf
2011-03-28 00:00:00
13347 2 020753 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf
2011-03-28 00:00:00
13348 2 020753 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020753s014lbl.pdf
2013-02-20 00:00:00
13349 2 020753 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf
2014-05-06 00:00:00
13350 2 020753 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020753s018lbl.pdf
2016-07-27 00:00:00
13351 2 020757 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s038lbl.pdf
2006-04-25 00:00:00
13352 2 020757 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s056lbl.pdf
2011-12-13 00:00:00
13353 2 020757 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s058lbl.pdf
2012-01-23 00:00:00
13354 2 020758 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020758s037lbl.pdf
2007-11-19 00:00:00
13355 2 020758 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf
2012-10-26 00:00:00
13356 2 020762 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s007lbl.pdf
2004-08-31 00:00:00
13357 2 020762 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20762s11lbl.pdf
2002-07-17 00:00:00
13358 2 020762 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20762slr021_nasonex_lbl.pd
f 2003-12-29 00:00:00
13359 2 020762 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s023lbl.pdf
2004-12-30 00:00:00
13360 2 020762 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020762s044lbl.pdf
2011-01-25 00:00:00
13361 2 020763 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf
2012-03-06 00:00:00
13362 2 020764 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20764lbl.pdf 1998-
08-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf
1998-12-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf
2003-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,0
20764SLRs3s14s18s19s20lbl.pdf 2013-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-
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13367 2 020764 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,0
20764SLRs3s14s18s19s20lbl.pdf 2013-09-06 00:00:00
13368 2 020764 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,0
20764SLRs3s14s18s19s20lbl.pdf 2013-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s
033,022251s002s009lbl.pdf 2015-01-05 00:00:00
13370 2 020764 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s0
36lbl.pdf 2009-06-07 00:00:00
13371 2 020764 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s
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13372 2 020764 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s
033,022251s002s009lbl.pdf 2015-01-05 00:00:00
13373 2 020764 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf
2015-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,0222
51s010lbl.pdf 2011-08-05 00:00:00
13375 2 020764 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,0222
51s012lbl.pdf 2011-12-02 00:00:00
13376 2 020764 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,0222
51s017lbl.pdf 2015-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf 1999-
04-26 00:00:00
13378 2 020766 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf
2001-04-23 00:00:00
13379 2 020766 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf
2004-11-01 00:00:00
13380 2 020766 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pd
f 2004-07-14 00:00:00
13381 2 020766 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf
2007-01-08 00:00:00
13382 2 020766 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf
2009-02-12 00:00:00
13383 2 020766 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf
2010-05-25 00:00:00
13384 2 020766 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf
2012-01-24 00:00:00
13385 2 020766 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
2013-10-18 00:00:00
13386 2 020768 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf
2004-11-19 00:00:00
13387 2 020768 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s
011lbl.pdf 2012-09-18 00:00:00
13388 2 020769 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf
2014-12-19 00:00:00
13389 2 020771 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20771lbl.pdf 1998-
03-25 00:00:00
13390 2 020771 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20771s4lbl.pdf
2001-04-06 00:00:00
13391 2 020771 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020771s013lbl.pdf
2005-10-24 00:00:00
13392 2 020771 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020771s019,021228s012lbl.p
df 2008-09-12 00:00:00
13393 2 020771 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020771s028lbl.pdf
2012-08-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20773lbl.pdf 1998-
10-29 00:00:00
13395 2 020774 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20774lbl.pdf 1998-
05-15 00:00:00
13396 2 020774 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020774Orig1s010lbl.pdf
2011-07-07 00:00:00
13397 2 020774 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s012lbl.pdf
2012-11-08 00:00:00
13398 2 020776 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20776_Daypro_alta_lbl.pdf
2002-10-17 00:00:00
13399 2 020776 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-
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13401 2 020778 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21
503slr003_viracept_lbl.pdf 2004-06-07 00:00:00
13402 2 020778 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,0215
03s007lbl.pdf 2006-12-28 00:00:00
13403 2 020778 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s
055,021503s015s016lbl.pdf 2010-05-03 00:00:00
13404 2 020778 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,0215
03s017lbl.pdf 2011-03-10 00:00:00
13405 2 020778 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,0215
03s018lbl.pdf 2012-04-09 00:00:00
13406 2 020779 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-
022,20779se5-042,21503se5-001_viracept_lbl.pdf 2004-04-05 00:00:00
13407 2 020779 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21
503slr003_viracept_lbl.pdf 2004-06-07 00:00:00
13408 2 020779 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s
055,021503s015s016lbl.pdf 2010-05-03 00:00:00
13409 2 020779 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,0215
03s017lbl.pdf 2011-03-10 00:00:00
13410 2 020779 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,0215
03s021lbl.pdf 2013-06-04 00:00:00
13411 2 020780 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf
2002-04-17 00:00:00
13412 2 020780 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780s
lr012,014,015_cipro_lbl.pdf 2004-04-05 00:00:00
13413 2 020780 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780s
lr012,014,015_cipro_lbl.pdf 2004-04-05 00:00:00
13414 2 020780 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780s
lr012,014,015_cipro_lbl.pdf 2004-04-05 00:00:00
13415 2 020780 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s
035,20780s016lbl.pdf 2005-01-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,01
8lbl.pdf 2004-07-21 00:00:00
13417 2 020780 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020780s24lbl.pdf
2007-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s4
9,20780s26,21473s24lbl.pdf 2008-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s7019847441985751207
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13420 2 020780 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.p
df 2011-11-16 00:00:00
13421 2 020780 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.p
df 2011-06-14 00:00:00
13422 2 020780 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,0198
57s059,020780s038,021473s033lbl.pdf 2011-11-04 00:00:00
13423 2 020780 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.p
df 2013-02-01 00:00:00
13424 2 020780 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.p
df 2013-08-15 00:00:00
13425 2 020780 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.p
df 2015-03-02 00:00:00
13426 2 020781 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20781lbl.pdf 1999-
01-27 00:00:00
13427 2 020781 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s
007lbl.pdf 2004-12-03 00:00:00
13428 2 020781 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,0207
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13429 2 020781 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,0207
81s018lbl.pdf 2014-09-22 00:00:00
13430 2 020782 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf
2003-04-04 00:00:00
13431 2 020785 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf 1998-
07-16 00:00:00
13432 2 020785 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf
2001-09-05 00:00:00
13433 2 020785 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.p
df 2003-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalom
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13435 2 020785 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalom
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13436 2 020785 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.p
df 2006-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf
2012-02-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-
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13439 2 020786 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf
2010-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf
2013-01-08 00:00:00
13441 2 020786 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033,
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13442 2 020788 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf
2003-04-24 00:00:00
13443 2 020788 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s017lbl.pdf
2011-03-14 00:00:00
13444 2 020788 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788Orig1s022lbl.pdf
2011-06-10 00:00:00
13445 2 020788 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020788s024lbl.pdf
2014-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf 2000-
03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf
2002-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf
2012-01-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
2010-04-20 00:00:00
13450 2 020796 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF 1999-
12-30 00:00:00
13451 2 020796 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf
2009-02-04 00:00:00
13452 2 020796 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf
2009-02-04 00:00:00
13453 2 020796 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf
2014-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf
2015-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf
2016-02-26 00:00:00
13456 2 020799 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799se2-
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13457 2 020799 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799slr012_floxin_lbl.pdf
2003-10-10 00:00:00
13458 2 020800 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
2011-01-31 00:00:00
13459 2 020800 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf
2014-04-25 00:00:00
13460 2 020800 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf
2016-05-20 00:00:00
13461 2 020801 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf 1998-
09-24 00:00:00
13462 2 020801 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf
2001-04-10 00:00:00
13463 2 020802 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.p
df 2003-06-08 00:00:00
13464 2 020802 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf
2014-04-22 00:00:00
13465 2 020802 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf
2014-07-30 00:00:00
13466 2 020803 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20803lbl.pdf 1998-
03-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf 1998-
02-10 00:00:00
13469 2 020813 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.p
df 2009-05-12 00:00:00
13470 2 020813 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s
007lbl.pdf 2010-09-07 00:00:00
13471 2 020815 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf
1999-09-30 00:00:00
13472 2 020816 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020816s019lbl.pdf
2015-11-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_PRNTLBL.PDF
2004-06-02 00:00:00
13474 2 020818 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s027lbl.pdf
2006-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s032lbl.pdf
2006-11-22 00:00:00
13476 2 020818 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020818s043lbl.pdf
2010-05-03 00:00:00
13477 2 020818 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818S051lbl.pdf
2012-02-17 00:00:00
13478 2 020818 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s053lbl.pdf
2012-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s060lbl.pdf
2014-06-03 00:00:00
13480 2 020818 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf
2014-03-19 00:00:00
13481 2 020819 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20819S3LBL.PDF
2000-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20819se5-
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13483 2 020819 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020819s015lbl.pdf
2005-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020822s29lbl.pdf
2005-02-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020822s034lbl.pdf
2007-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf
2008-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.p
df 2009-02-04 00:00:00
13488 2 020822 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s
017lbl.pdf 2011-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s043lbl.pdf
2012-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf
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2012-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-
855_Mesnex_Prntlbl.pdf 2004-06-09 00:00:00
13620 2 020855 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020855s002lbl.pdf
2014-03-19 00:00:00
13621 2 020857 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf
2002-08-09 00:00:00
13622 2 020857 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s018lbl.pdf
2006-06-28 00:00:00
13623 2 020857 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s020lbl.pdf
2006-10-26 00:00:00
13624 2 020857 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020857s021lbl.pdf
2007-04-25 00:00:00
13625 2 020857 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020857s023lbl.pdf
2009-02-04 00:00:00
13626 2 020857 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020857s028lbl.pdf
2011-12-02 00:00:00
13627 2 020857 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/20857s030lbl.pdf
2015-09-29 00:00:00
13628 2 020859 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf
2007-12-14 00:00:00
13629 2 020862 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.p
df 2006-07-21 00:00:00
13630 2 020862 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf
2008-07-14 00:00:00
13631 2 020862 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf
2009-07-23 00:00:00
13632 2 020862 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020862s030lbl.pdf
2011-03-04 00:00:00
13633 2 020863 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/cilo_label.htm
2004-06-14 00:00:00
13634 2 020863 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s019lbl.pdf
2007-01-24 00:00:00
13635 2 020863 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s021lbl.pdf
2007-11-19 00:00:00
13636 2 020863 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf
2015-01-29 00:00:00
13637 2 020863 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s023lbl.pdf
2015-08-04 00:00:00
13638 2 020864 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf 1998-
06-29 00:00:00
13639 2 020864 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019
,020865s012s016s018s020s021lbl.pdf 2011-12-20 00:00:00
13640 2 020864 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019
,020865s012s016s018s020s021lbl.pdf 2011-12-20 00:00:00
13641 2 020865 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf 1998-
06-29 00:00:00
13642 2 020865 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf
2010-08-19 00:00:00
13643 2 020865 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019
,020865s012s016s018s020s021lbl.pdf 2011-12-20 00:00:00
13644 2 020866 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020866s008lbl.pdf
2015-10-22 00:00:00
13645 2 020866 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020866s009lbl.pdf
2016-02-11 00:00:00
13646 2 020868 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020868s005lbl.pdf
2003-04-28 00:00:00
13647 2 020868 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020868s008lbl.pdf
2010-08-20 00:00:00
13648 2 020869 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s020lbl.pdf
2005-03-30 00:00:00
13649 2 020869 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020869s034lbl.pdf
2008-11-07 00:00:00
13650 2 020869 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020869s036lbl.pdf
2010-06-24 00:00:00
13651 2 020869 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020869s040lbl.pdf
2015-08-04 00:00:00
13652 2 020870 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20870lbl.pdf 1998-
08-07 00:00:00
13653 2 020870 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20870s013lbl.pdf
2005-01-18 00:00:00
13654 2 020872 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf
2005-10-19 00:00:00
13655 2 020872 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.p
df 2008-06-30 00:00:00
13656 2 020872 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf
2012-03-27 00:00:00
13657 2 020872 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf
2014-08-06 00:00:00
13658 2 020873 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf 2000-
12-15 00:00:00
13659 2 020874 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20874lbl.pdf 2000-
10-05 00:00:00
13660 2 020882 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf 2000-
10-12 00:00:00
13661 2 020882 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s
016lbl.pdf 2005-02-23 00:00:00
13662 2 020882 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,0211
29s033lbl.pdf 2011-08-11 00:00:00
13663 2 020882 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s
038s039s040,021129s035s036s037lbl.pdf 2013-05-09 00:00:00
13664 2 020883 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20883lbl.pdf 2000-
06-30 00:00:00
13665 2 020883 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020883s014lbl.pdf
2008-05-19 00:00:00
13666 2 020883 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020883s016lbl.pdf
2014-03-11 00:00:00
13667 2 020884 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf
2003-04-24 00:00:00
13668 2 020884 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf
2007-03-31 00:00:00
13669 2 020884 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf
2006-12-04 00:00:00
13670 2 020886 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf 1999-
02-02 00:00:00
13671 2 020887 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20887lbl.pdf 1998-
09-14 00:00:00
13672 2 020889 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20889s2lbl.pdf
2004-06-08 00:00:00
13673 2 020892 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf 1998-
09-25 00:00:00
13674 2 020892 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf
2011-11-04 00:00:00
13675 2 020895 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/viagralabel2.pdf
1998-03-27 00:00:00
13676 2 020895 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf
2002-09-19 00:00:00
13677 2 020895 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf
2002-09-19 00:00:00
13678 2 020895 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s20lbl.pdf
2006-06-28 00:00:00
13679 2 020895 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020895s021lbl.pdf
2005-07-08 00:00:00
13680 2 020895 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s023lbl.pdf
2006-10-11 00:00:00
13681 2 020895 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020895s026lbl.pdf
2008-02-26 00:00:00
13682 2 020895 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020895s033lbl.pdf
2010-01-20 00:00:00
13683 2 020895 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s045lbl.pdf
2015-09-23 00:00:00
13684 2 020896 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S6lbl.pdf
2003-04-25 00:00:00
13685 2 020896 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf
2001-09-07 00:00:00
13686 2 020896 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20896slr012_xeloda_lbl.pdf
2003-03-26 00:00:00
13687 2 020896 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s036lbl.pdf
2015-03-05 00:00:00
13688 2 020896 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s037lbl.pdf
2015-03-24 00:00:00
13689 2 020897 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-
033,18211se8-016,20897slr010_ditropan_lbl.pdf 2003-04-16 00:00:00
13690 2 020897 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,0208
97s018lbl.pdf 2008-02-14 00:00:00
13691 2 020897 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020897s024lbl.pdf
2009-07-23 00:00:00
13692 2 020897 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s028lbl.pdf
2011-06-30 00:00:00
13693 2 020897 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s031lbl.pdf
2012-11-15 00:00:00
13694 14 020898 SUPPL 21 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13695 14 020898 SUPPL 29 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13696 14 020898 SUPPL 38 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13697 14 020898 SUPPL 51 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
13698 2 020899 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020899s007lbl.pdf
2007-10-04 00:00:00
13699 2 020901 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lb
l.pdf 2004-05-27 00:00:00
13700 2 020902 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_prntlbl.pdf
1999-08-05 00:00:00
13701 2 020903 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf
1998-12-09 00:00:00
13702 2 020903 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s5lbl.pdf
2003-04-25 00:00:00
13703 2 020903 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s10lbl.pdf
2003-04-25 00:00:00
13704 2 020903 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf
2001-07-26 00:00:00
13705 2 020903 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf
2003-04-25 00:00:00
13706 2 020903 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s14lbl.pdf
2003-04-25 00:00:00
13707 2 020903 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903s23lbl.pdf
2002-09-03 00:00:00
13708 2 020903 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr029_rebetol_lbl.pd
f 2003-06-08 00:00:00
13709 2 020903 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr032_rebetol_lbl.pd
f 2003-10-16 00:00:00
13710 2 020903 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr033_rebetron_lbl.p
df 2004-06-10 00:00:00
13711 2 020903 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr034_rebetol_lbl.pd
f 2004-06-24 00:00:00
13712 2 020903 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s039lbl.pdf
2007-04-20 00:00:00
13713 2 020903 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s040lbl.pdf
2007-12-14 00:00:00
13714 2 020903 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s
044s045lbl.pdf 2009-11-16 00:00:00
13715 2 020903 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s
044s045lbl.pdf 2009-11-16 00:00:00
13716 2 020903 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.p
df 2010-10-29 00:00:00
13717 2 020903 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.p
df 2013-11-22 00:00:00
13718 2 020905 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20905lbl.pdf 1998-
09-10 00:00:00
13719 2 020905 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-
006_arava_lbl.pdf 2003-06-22 00:00:00
13720 2 020905 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020905s016lbl.pdf
2007-11-13 00:00:00
13721 2 020905 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020905s020lbl.pdf
2010-09-10 00:00:00
13722 2 020905 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020905s025lbl.pdf
2012-11-06 00:00:00
13723 2 020905 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020905s027lbl.pdf
2015-09-03 00:00:00
13724 2 020907 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf
2013-10-17 00:00:00
13725 2 020908 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20908lbl.pdf 1999-
03-26 00:00:00
13726 2 020911 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
911_QVAR_Prntlbl.pdf 2004-06-14 00:00:00
13727 2 020911 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf
2014-05-28 00:00:00
13728 2 020912 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20912lbl.pdf 1998-
05-14 00:00:00
13729 2 020912 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.p
df 2012-06-11 00:00:00
13730 2 020912 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf
2013-10-17 00:00:00
13731 2 020913 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.p
df 2012-06-11 00:00:00
13732 2 020918 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20918lbl.pdf 1998-
06-22 00:00:00
13733 2 020918 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918s012lbl.pdf
2004-12-29 00:00:00
13734 2 020918 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020918s034lbl.pdf
2012-01-06 00:00:00
13735 2 020918 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020918s043lbl.pdf
2015-12-15 00:00:00
13736 2 020919 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20919lbl.pdf 2002-
06-21 00:00:00
13737 2 020919 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,
006lbl.pdf 2005-08-19 00:00:00
13738 2 020919 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.p
df 2007-05-29 00:00:00
13739 2 020919 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,0214
83s007lbl.pdf 2013-07-05 00:00:00
13740 2 020919 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,0214
83s010lbl.pdf 2013-08-15 00:00:00
13741 2 020919 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.p
df 2013-12-19 00:00:00
13742 2 020920 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020920s012lbl.pdf
2007-04-16 00:00:00
13743 2 020920 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020920s023lbl.pdf
2009-06-22 00:00:00
13744 2 020920 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020920s031lbl.pdf
2012-07-10 00:00:00
13745 2 020920 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/20920s033lbl.pdf
2013-04-30 00:00:00
13746 2 020922 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20922lbl.pdf 1999-
12-10 00:00:00
13747 2 020922 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020922s003lbl.pdf
2007-05-01 00:00:00
13748 2 020922 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020922s006lbl.pdf
2010-01-04 00:00:00
13749 2 020926 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20926lbl.pdf 1998-
10-30 00:00:00
13750 2 020928 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20928lbl.pdf 1998-
09-11 00:00:00
13751 2 020929 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017577s034ltr.pdf
2008-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017577s036ltr.pdf
2011-08-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s043ltr.pdf
2016-02-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017604s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017604Orig1s046ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017624s034ltr.pdf
2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017630s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17634slr059ltr.pdf
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017634Orig1s069ltr.pdf
2014-12-24 00:00:00
13874 14 017646 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17648scs061ltr.pdf
2002-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17648slr058ltr.pdf
2003-01-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017651s042ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017694s050ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17714s21ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017760Orig1s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17765scp024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17766s028ltr.pdf
2002-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17766scs029ltr.pdf
2004-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017766s030LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017768s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017771Orig1s035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17781s15ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017783s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017806s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017808s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017821Orig1s051ltr.pdf
2013-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17823s023ltr.pdf
2004-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017831s054ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017831s055ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017831Orig1s056ltr.pdf
2013-04-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s058ltr.pdf
2015-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17849slr039,18571slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr040ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr044ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr045ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s056ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf
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2004-03-28 00:00:00
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2013-05-02 00:00:00
13944 14 017881 SUPPL 9 This Former NDA Was Deemed To Be a BLA on
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2003-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s39.pdf
1998-10-29 00:00:00
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et al_ltr.pdf 2005-08-31 00:00:00
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2005-05-25 00:00:00
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2002-03-27 00:00:00
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2005-08-31 00:00:00
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2007-01-08 00:00:00
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2008-01-09 00:00:00
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2010-03-08 00:00:00
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2011-03-23 00:00:00
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2010-10-26 00:00:00
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2011-09-28 00:00:00
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2002-08-01 00:00:00
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14013 1 018081 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,
018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf2013-03-01 00:00:00
14017 1 018081 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082
Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf
2013-09-17 00:00:00
14018 1 018081 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082
Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf
2014-11-24 00:00:00
14019 1 018081 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082
Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf
2014-08-21 00:00:00
14021 1 018081 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s
15,18723s33,19680s22,21168s14.pdf 2006-10-23 00:00:00
14024 1 018082 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018081s047,018082s032l
tr.pdf 2009-05-01 00:00:00
14026 1 018082 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,
018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf2013-03-01 00:00:00
14028 1 018082 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018084s052ltr.pdf
2008-01-24 00:00:00
14032 1 018086 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086s058.pdf
2002-04-29 00:00:00
14033 2 020972 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20972s13lbl.pdf
2003-04-25 00:00:00
14034 2 020972 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_su
stiva_lbl.pdf 2003-06-22 00:00:00
14035 2 020972 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr019,21360slr004_su
stiva_lbl.pdf 2003-06-22 00:00:00
14036 2 020972 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_su
stiva_lbl.pdf 2003-12-01 00:00:00
14037 2 020972 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf
2004-08-25 00:00:00
14038 2 020972 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf
2004-11-01 00:00:00
14039 2 020972 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.p
df 2005-04-28 00:00:00
14040 2 020972 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020972s027lbl.pdf
2007-02-05 00:00:00
14041 2 020972 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.p
df 2009-04-23 00:00:00
14042 2 020972 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.p
df 2010-04-04 00:00:00
14043 2 020972 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s038lbl.pdf
2011-09-26 00:00:00
14044 2 020972 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.p
df 2012-06-26 00:00:00
14045 2 020973 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20973s8lbl.pdf
2003-04-25 00:00:00
14046 2 020973 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973s009lbl.pdf
2002-02-12 00:00:00
14047 2 020973 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020973s022lbl.pdf
2008-06-30 00:00:00
14048 2 020973 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020973s025lbl.pdf
2010-09-10 00:00:00
14049 2 020973 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020973s028lbl.pdf
2011-05-26 00:00:00
14050 2 020973 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020973s032lbl.pdf
2013-04-23 00:00:00
14051 2 020973 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pd
f 2014-12-29 00:00:00
14052 2 020975 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
937S003_OptiMark_Prntlbl.pdf 2004-06-10 00:00:00
14053 2 020975 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020975s010lbl.pdf
2008-08-26 00:00:00
14054 2 020975 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,0209
75s012lbl.pdf 2007-09-06 00:00:00
14055 2 020975 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020975s017lbl.pdf
2010-12-20 00:00:00
14056 2 020975 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf
2013-08-27 00:00:00
14057 2 020975 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26
lbl.pdf 2014-11-26 00:00:00
14058 2 020976 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf
1999-12-08 00:00:00
14059 2 020976 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lb
l.pdf 2006-08-07 00:00:00
14060 2 020976 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,0209
75s012lbl.pdf 2007-09-06 00:00:00
14061 2 020976 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020976s016lbl.pdf
2010-12-20 00:00:00
14062 2 020976 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26
lbl.pdf 2014-11-26 00:00:00
14063 2 020977 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf
2002-10-02 00:00:00
14064 2 020977 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf
2002-08-14 00:00:00
14065 2 020977 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_zi
agen_lbl.pdf 2003-09-25 00:00:00
14066 2 020977 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf
2004-08-05 00:00:00
14067 2 020977 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.p
df 2006-08-14 00:00:00
14068 2 020977 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.p
df 2008-07-22 00:00:00
14069 2 020977 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.p
df 2009-01-02 00:00:00
14070 2 020977 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.p
df 2011-11-22 00:00:00
14071 2 020978 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf
2002-10-02 00:00:00
14072 2 020978 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf
2002-08-14 00:00:00
14073 2 020978 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_zi
agen_lbl.pdf 2003-09-25 00:00:00
14074 2 020978 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf
2004-08-05 00:00:00
14075 2 020978 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf
2004-07-28 00:00:00
14076 2 020978 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.p
df 2007-05-09 00:00:00
14077 2 020978 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.p
df 2012-03-16 00:00:00
14078 2 020980 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020980s005lbl.pdf
2007-07-27 00:00:00
14079 2 020981 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf 2007-
10-12 00:00:00
14080 2 020981 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf
2010-07-06 00:00:00
14081 2 020981 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf
2011-10-12 00:00:00
14082 2 020983 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf
2008-03-27 00:00:00
14083 2 020983 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf
2015-01-09 00:00:00
14084 2 020984 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20984lbl.pdf 1999-
08-18 00:00:00
14085 2 020984 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020984s003lbl.pdf
2010-11-22 00:00:00
14086 2 020985 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20985slr004_carac_lbl.pdf
2003-12-29 00:00:00
14087 2 020986 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf 2020-
03-23 00:00:00
14088 14 020986 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14089 14 020986 SUPPL 40 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14090 14 020986 SUPPL 45 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14091 14 020986 SUPPL 55 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14092 14 020986 SUPPL 59 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14093 14 020986 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14094 14 020986 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14095 14 020986 SUPPL 82 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14096 2 020987 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf 2000-
02-02 00:00:00
14097 2 020987 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.p
df 2004-04-05 00:00:00
14098 2 020987 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr022_protonix_lbl.p
df 2004-01-15 00:00:00
14099 2 020987 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037l
bl.pdf 2009-11-16 00:00:00
14100 2 020987 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.p
df 2010-09-10 00:00:00
14101 2 020987 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.p
df 2011-11-01 00:00:00
14102 2 020987 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.p
df 2012-10-15 00:00:00
14103 2 020987 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-
020987s049lbl.pdf 2014-12-29 00:00:00
14104 2 020988 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.p
df 2004-05-07 00:00:00
14105 2 020988 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.p
df 2004-04-05 00:00:00
14106 2 020988 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988s027lbl.pdf
2004-12-08 00:00:00
14107 2 020988 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf
2005-08-08 00:00:00
14108 2 020988 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf
2011-06-27 00:00:00
14109 2 020988 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf
2012-05-16 00:00:00
14110 2 020989 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020989s006lbl.pdf
2005-12-15 00:00:00
14111 2 020990 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20990lbl.pdf 1999-
12-07 00:00:00
14112 2 020990 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf
2003-03-05 00:00:00
14113 2 020990 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,01
7lbl.pdf 2004-08-25 00:00:00
14114 2 020990 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf
2005-07-14 00:00:00
14115 2 020990 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf
2005-07-14 00:00:00
14116 2 020990 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s
026lbl.pdf 2006-09-15 00:00:00
14117 2 020990 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027l
bl.pdf 2007-08-03 00:00:00
14118 2 020990 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.p
df 2009-02-04 00:00:00
14119 2 020990 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s0
40lbl.pdf 2012-12-28 00:00:00
14120 2 020990 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s
033s036s037lbl.pdf 2011-08-24 00:00:00
14121 2 020990 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.p
df 2013-02-06 00:00:00
14122 2 020990 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s0
40lbl.pdf 2012-12-28 00:00:00
14123 2 020992 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf 1999-
03-24 00:00:00
14124 2 020992 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf
2002-06-21 00:00:00
14125 2 020992 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf
2015-03-24 00:00:00
14126 2 020997 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20997lbl.pdf 1999-
08-05 00:00:00
14127 2 020998 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20998lbl.pdf 1998-
12-31 00:00:00
14128 2 020998 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf 2004-
05-28 00:00:00
14129 2 020998 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20998s009lbl.pdf
2002-06-07 00:00:00
14130 2 020998 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20998s10lbl.pdf
2001-10-18 00:00:00
14131 2 020998 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20998slr016_celebrex_lbl.p
df 2004-01-15 00:00:00
14132 2 020998 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf
2005-08-03 00:00:00
14133 2 020998 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020998s021lbl.pdf
2006-12-26 00:00:00
14134 2 020998 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s026lbl.pdf
2008-01-18 00:00:00
14135 2 020998 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s027lbl.pdf
2009-01-06 00:00:00
14136 2 020998 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.p
df 2011-02-09 00:00:00
14137 2 021001 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_prntlbl.pdf
2001-05-07 00:00:00
14138 2 021001 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf
2009-04-03 00:00:00
14139 2 021001 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf
2009-05-11 00:00:00
14140 2 021003 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-
HBV_prntlbl.pdf 1998-12-08 00:00:00
14141 2 021003 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf
2004-12-03 00:00:00
14142 2 021003 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021003s015,021004s015lbl.p
df 2013-12-23 00:00:00
14143 2 021004 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf
2004-12-03 00:00:00
14144 2 021004 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021003s013,021004s013lbl.p
df 2011-01-24 00:00:00
14145 2 021005 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21005lbl.pdf 2000-
10-16 00:00:00
14146 2 021005 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021005s013lbl.pdf
2011-12-14 00:00:00
14147 2 021005 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021005s016lbl.pdf
2016-05-11 00:00:00
14148 2 021006 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf
2009-04-03 00:00:00
14149 2 021007 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-
007SE7006_Agenerase_Prntlbl.pdf 2001-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf
2002-08-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_ag
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21008lbl.pdf 1998-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf
2006-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s030lbl.pdf
2014-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf 1999-
12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf
2007-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21011lbl.pdf 2000-
08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf
2009-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21012lbl.pdf 1999-
08-03 00:00:00
14161 2 021014 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf
2005-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf
2005-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21015lbl.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21015s012lbl.pdf
2004-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf
2008-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021015s022lbl.pdf
2009-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s028lbl.pdf
2011-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.pdf
2012-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021015s036lbl.pdf
2013-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015s039lbl.pdf
2014-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf
2015-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf
2010-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021016s018lbl.pdf
2011-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.
pdf 2013-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.
pdf 2013-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.
pdf 2013-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21017scm013_humalog_lbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lb
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017scm018_humalog_lbl.pd
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14183 2 021017 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,0210
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,0210
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s082lbl.pdf
2020-03-23 00:00:00
14186 2 021017 SUPPL 108 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021017s108lbl.pdf
2020-03-23 00:00:00
14187 14 021018 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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14188 14 021018 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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14189 14 021018 SUPPL 69 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf
2004-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021024s008lbl.pdf
2009-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021
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14195 2 021027 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.p
df 2006-07-21 00:00:00
14196 2 021027 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021027s026lbl.pdf
2016-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf
2005-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.p
df 2011-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.p
df 2011-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
2015-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf
2016-02-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21035lbl.pdf 1999-
11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009l
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085
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14211 2 021035 SUPPL 89 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s091lbl.pdf
2014-03-10 00:00:00
14213 2 021035 SUPPL 93 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21036lbl.pdf 1999-
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14215 2 021036 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21036S4lbl.pdf
2001-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021036s008lbl.pdf
2006-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021036s012lbl.pdf
2007-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021036s027lbl.pdf
2011-12-23 00:00:00
14219 2 021037 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.p
df 2010-09-07 00:00:00
14220 2 021037 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021037s023lbl.pdf
2010-12-20 00:00:00
14221 2 021037 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.p
df 2013-10-22 00:00:00
14222 2 021037 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021037s031lbl.pdf
2015-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21038lbl.pdf 1999-
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14224 2 021038 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021038s017lbl.pdf
2010-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s021lbl.pdf
2013-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf
2014-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf
2002-08-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_ag
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21040LBL.PDF 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
2004-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
2004-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21042lbl.pdf 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-
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14241 2 021042 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021044s013lbl.pdf
2014-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21045lbl.pdf 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021046s020lbl.pdf
2012-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21048lbl.pdf 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2004-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
2004-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.p
df 2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf
2003-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021055s008lbl.pdf
2014-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021055s010lbl.pdf
2015-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021056s003lbl.pdf
2011-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021057s007lbl.pdf
2008-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021057s010lbl.pdf
2015-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf
2007-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021060s006lbl.pdf
2011-09-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf
2007-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf
2007-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf
2008-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf
2011-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf
2015-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLA.PDF 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21066lbl.pdf 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf
2010-09-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf 1998-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf
2005-01-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf
2005-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf
2006-06-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf
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14282 2 021071 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf
2012-06-06 00:00:00
14283 2 021071 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf
2014-05-12 00:00:00
14284 2 021073 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf 1999-
07-15 00:00:00
14285 2 021073 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf
2003-06-22 00:00:00
14286 2 021073 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf
2004-08-05 00:00:00
14287 2 021073 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf
2004-07-21 00:00:00
14288 2 021073 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf
2007-09-11 00:00:00
14289 2 021073 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf
2011-02-09 00:00:00
14290 2 021073 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf
2009-09-18 00:00:00
14291 2 021073 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
2011-08-04 00:00:00
14292 2 021073 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
2011-08-04 00:00:00
14293 2 021074 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
074_Avagard_Prntlbl.pdf 2001-10-02 00:00:00
14296 2 021076 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve_prntlbl.pdf
1999-11-29 00:00:00
14297 2 021077 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf
2003-08-15 00:00:00
14298 2 021077 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf
2007-02-26 00:00:00
14299 2 021077 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf
2006-03-03 00:00:00
14300 2 021077 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf
2008-05-02 00:00:00
14301 2 021077 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf
2010-06-28 00:00:00
14302 2 021077 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf
2014-04-16 00:00:00
14303 2 021077 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf
2014-12-20 00:00:00
14304 2 021077 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf
2016-05-05 00:00:00
14305 2 021078 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s002lbl.pdf
2004-09-07 00:00:00
14306 2 021078 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21078s3lbl.pdf
2002-08-02 00:00:00
14307 2 021078 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s007lbl.pdf
2004-12-03 00:00:00
14308 2 021078 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf
2005-03-03 00:00:00
14309 2 021078 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s014lbl.pdf
2008-06-12 00:00:00
14310 2 021078 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf
2013-03-01 00:00:00
14311 14 021081 SUPPL 14 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14312 14 021081 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14313 14 021081 SUPPL 24 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14314 14 021081 SUPPL 63 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14315 2 021083 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Ra
pamune_lbl.pdf 2003-01-23 00:00:00
14316 2 021083 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Ra
pamune_lbl.pdf 2003-01-23 00:00:00
14317 2 021083 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Ra
pamune_lbl.pdf 2003-01-23 00:00:00
14318 2 021083 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Ra
pamune_lbl.pdf 2003-10-10 00:00:00
14319 2 021083 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,
028lbl.pdf 2005-07-07 00:00:00
14320 2 021083 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,
028lbl.pdf 2005-07-07 00:00:00
14321 2 021083 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,
031lbl.pdf 2005-10-14 00:00:00
14322 2 021083 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s
034lbl.pdf 2006-06-06 00:00:00
14323 2 021083 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.p
df 2007-01-16 00:00:00
14324 2 021083 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.p
df 2008-01-18 00:00:00
14325 2 021083 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.p
df 2007-10-22 00:00:00
14326 2 021083 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s036s037,021110s047s
048lbl.pdf 2008-03-07 00:00:00
14327 2 021083 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.p
df 2009-02-04 00:00:00
14328 2 021083 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.p
df 2009-10-01 00:00:00
14329 2 021083 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s
054lbl.pdf 2010-05-03 00:00:00
14330 2 021083 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s
054lbl.pdf 2010-05-03 00:00:00
14331 2 021083 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.p
df 2010-08-27 00:00:00
14332 2 021083 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.p
df 2012-12-14 00:00:00
14333 2 021083 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.p
df 2015-03-09 00:00:00
14334 2 021083 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.p
df 2015-11-12 00:00:00
14335 2 021085 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf
2003-02-28 00:00:00
14336 2 021085 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-
022,21277se1-017_avelox_lbl.pdf 2004-05-27 00:00:00
14337 2 021085 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_av
elox_lbl.pdf 2004-04-05 00:00:00
14338 2 021085 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf
2004-07-30 00:00:00
14339 2 021085 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,
025lbl.pdf 2005-11-30 00:00:00
14340 2 021085 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,
025lbl.pdf 2005-11-30 00:00:00
14341 2 021085 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.p
df 2008-02-25 00:00:00
14342 2 021085 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.p
df 2009-05-15 00:00:00
14343 2 021085 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s044lbl.pdf
2010-10-25 00:00:00
14344 2 021085 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.p
df 2009-12-02 00:00:00
14345 2 021085 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s
050lbl.pdf 2011-10-20 00:00:00
14346 2 021085 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s
050lbl.pdf 2011-10-20 00:00:00
14347 2 021085 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.p
df 2013-08-15 00:00:00
14348 2 021085 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1
s063lbledt.pdf 2016-07-26 00:00:00
14349 2 021086 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,0205
92s035lbl.pdf 2006-02-28 00:00:00
14350 2 021086 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,0212
53s021lbl.pdf 2006-12-04 00:00:00
14351 2 021086 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.p
df 2009-03-20 00:00:00
14352 2 021086 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s
023,021253s026lbl.pdf 2007-07-10 00:00:00
14353 2 021086 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,0212
53s036lbl.pdf 2009-09-17 00:00:00
14354 2 021086 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,0212
53s037lbl.pdf 2010-01-29 00:00:00
14355 2 021086 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s
034,021253s039s043lbl.pdf 2010-06-03 00:00:00
14356 2 021086 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,0212
53s045lbl.pdf 2010-12-04 00:00:00
14357 2 021086 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s
039lbl.pdf 2011-06-29 00:00:00
14358 2 021086 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.p
df 2013-07-30 00:00:00
14359 2 021086 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,0212
53s049lbl.pdf 2015-07-24 00:00:00
14360 2 021087 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf
2001-07-24 00:00:00
14361 2 021087 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf
2001-07-24 00:00:00
14362 2 021087 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Ta
miflu_lbl.pdf 2004-07-01 00:00:00
14363 2 021087 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s025lbl.pdf
2005-11-01 00:00:00
14364 2 021087 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s026lbl.pdf
2005-08-19 00:00:00
14365 2 021087 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.p
df 2006-01-10 00:00:00
14366 2 021087 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033lbl.pdf
2006-11-14 00:00:00
14367 2 021087 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.p
df 2010-12-16 00:00:00
14368 2 021087 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s
035lbl.pdf 2010-03-03 00:00:00
14369 2 021087 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s055lbl.pdf
2010-11-05 00:00:00
14370 2 021087 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.p
df 2011-03-23 00:00:00
14371 2 021087 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.p
df 2012-08-17 00:00:00
14372 2 021087 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.p
df 2013-08-12 00:00:00
14373 2 021087 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.p
df 2014-10-15 00:00:00
14374 2 021088 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s007lbl.pdf
2005-09-14 00:00:00
14375 2 021088 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf
2011-01-20 00:00:00
14376 2 021090 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021090s004lbl.pdf
2007-03-31 00:00:00
14377 2 021093 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf 2000-
09-05 00:00:00
14378 2 021093 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf
2006-08-18 00:00:00
14379 2 021093 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf
2011-03-11 00:00:00
14380 2 021093 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf
2015-02-10 00:00:00
14381 2 021093 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf
2016-03-04 00:00:00
14382 2 021097 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21097lbl.pdf 2000-
09-21 00:00:00
14383 2 021098 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf
2003-05-13 00:00:00
14384 2 021098 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf
2012-02-13 00:00:00
14385 2 021098 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf
2015-06-04 00:00:00
14386 2 021103 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21103lbl.pdf 2000-
04-11 00:00:00
14387 2 021105 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21105lbl.pdf 2001-
06-26 00:00:00
14388 14 021106 SUPPL 36 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14389 2 021107 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf
2002-06-07 00:00:00
14390 2 021107 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf
2005-02-04 00:00:00
14391 2 021107 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf
2005-02-23 00:00:00
14392 2 021107 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf
2006-03-14 00:00:00
14393 2 021107 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf
2010-09-07 00:00:00
14394 2 021107 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf
2016-01-26 00:00:00
14395 2 021108 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21108lbl.pdf 2000-
08-31 00:00:00
14396 2 021108 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21108s1lbl.pdf
2004-06-15 00:00:00
14397 2 021110 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf
2003-04-11 00:00:00
14398 2 021110 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Ra
pamune_lbl.pdf 2003-01-23 00:00:00
14399 2 021110 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Ra
pamune_lbl.pdf 2003-01-23 00:00:00
14400 2 021110 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Ra
pamune_lbl.pdf 2003-03-21 00:00:00
14401 2 021110 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Ra
pamune_lbl.pdf 2003-03-28 00:00:00
14402 2 021110 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,
028lbl.pdf 2005-07-07 00:00:00
14403 2 021110 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,
031lbl.pdf 2005-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s
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14405 2 021110 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.p
df 2007-01-16 00:00:00
14406 2 021110 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.p
df 2006-10-23 00:00:00
14407 2 021110 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.p
df 2007-01-16 00:00:00
14408 2 021110 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.p
df 2007-10-22 00:00:00
14409 2 021110 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.p
df 2009-10-14 00:00:00
14410 2 021110 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021112s009lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21120.pdf_Novantrone_Prntlbl
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21121s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021121s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021121s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s029lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s032lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021134s005lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136s1lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21142se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142slr009_olux_lbl.pdf
2003-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142scs010_olux_lbl.pdf
2004-01-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021142s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21143lbl.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21144_ketek_lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021144s011lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021144s012lbl.pdf
2007-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21145lbl.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021146s015lbl.pdf
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf 2020-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021149s013ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21150lbl.pdf 2001-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21150se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf
2011-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf
2015-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf
2004-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf
2005-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf
2006-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf
2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf
2006-09-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,0221
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,0219
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,0219
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,0219
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,0221
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,0221
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_0221
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,0221
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,0221
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021158s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s012lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021158s023lbl.pdf
2016-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf
2012-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf
2012-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21163lbl.pdf 2000-
05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21163s011lbl.pdf
2004-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21165lbl.pdf 2001-
12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf
2012-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21166_estrogel_lbl.pdf
2004-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021166s007lbl.pdf
2008-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021166s010lbl.pdf
2014-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf
2000-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21168lbl.pdf 2000-
08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21168s1lbl.pdf
2002-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21168se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021168s015lbl.pdf
2008-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf
2011-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf
2011-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s025lbl.pdf
2013-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s026lbl.pdf
2014-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s029lbl.pdf
2014-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168Orig1s030lbl.pdf
2015-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s033lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21169lbl.pdf 2001-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,0216
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,0216
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14564 14 021172 SUPPL 45 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14565 14 021172 SUPPL 51 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14566 14 021172 SUPPL 63 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
14567 14 021172 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf
2002-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf
2003-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pd
f 2003-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021176s019lbl.pdf
2007-08-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf 2009-
10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21178s4lbl.pdf
2002-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21178se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021178s009lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021178s012lbl.pdf
2010-12-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21179lbl.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s020lbl.pdf
2007-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s021lbl.pdf
2007-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021179s032lbl.pdf
2016-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf
2006-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf
2008-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf
2009-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf
2009-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf
2010-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf
2011-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf
2012-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf
2014-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s4lbl.pdf
2002-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf
2002-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021183s022lbl.pdf
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2010-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21191lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21192s2lbl.pdf
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_prntlbl.pdf
2001-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_l
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021227s023lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s027lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s031lbl.pdf
2013-01-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf
2016-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21228s1lbl.pdf
2003-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021228s007lbl.pdf
2005-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021228s021lbl.pdf
2012-08-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21229lbl_Part2.pdf
2003-06-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021229s005lbl.pdf
2006-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021229s006lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021229Orig1s023lbl.pdf
2012-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021229Orig1s025lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf 2001-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021232s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021235s025lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21241lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021241s025lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21246LBL.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s1lbl.pdf
2003-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s3lbl.pdf
2003-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021247LBL.pdf 2006-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021247s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf
2010-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021248s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226se7-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,0205
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21256_humansecretin_lbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21287_uroxatral_lbl.pdf
2003-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s005lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021287s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021287s011lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021287s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s016lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021287s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,0224
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf
2009-03-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18086scs060ltr.pdf
2003-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf
2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018086s075ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018110s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018117s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18123scs014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018124s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018140Orig1s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18147slr028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018147s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18150scs020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s7
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tr.pdf 2010-03-03 00:00:00
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s049ltr.pdf 2011-05-19 00:00:00
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tr.pdf 2011-07-28 00:00:00
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Orig1s051ltr.pdf 2012-08-03 00:00:00
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Orig1s056ltr.pdf 2014-07-21 00:00:00
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Orig1s057ltr.pdf 2016-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015923Orig1s094,018701
Orig1s072ltr.pdf 2016-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr00
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tr.pdf 2011-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018704Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18716scm023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,
18723s024,19680s015,20593s009,2116 2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018723s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s
15,18723s33,19680s22,21168s14.pdf 2006-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018723s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082
Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021299s032lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s006lbl.pdf
2005-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s007lbl.pdf
2007-01-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s008lbl.pdf
2006-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf
2006-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf
2006-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021368s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021368s023lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s026lbl.pdf
2015-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021372s002lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021372s006lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf
2008-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s018s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf 2002-
04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf
2003-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021378s005lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21379lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf 2004-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021392lbl.pdf 2003-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21392se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021392s010lbl.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021392s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf
2006-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395_spiriva_lbl.pdf
2004-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf
2006-12-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s014lbl.pdf
2009-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf
2006-12-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s029lbl.pdf
2009-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021395s033lbl.pdf
2011-07-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021395s040lbl.pdf
2015-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21399slr003_Iressa_lbl.pdf
2004-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021399s008lbl.pdf
2005-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s002lbl.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021400s011lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021400s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021400s016lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021400s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/21400s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21402lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021402s017lbl.pdf
2008-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021402s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021406lbl.pdf 2005-
08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021406s008lbl.pdf
2009-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021406s016lbl.pdf
2011-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21408lbl.pdf 2002-
10-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021409s036lbl.pdf
2012-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21410scf001_avandamet_lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s016lbl.pdf
2007-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s022lbl.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021410s025lbl.pdf
2008-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s027lbl.pdf
2011-05-17 00:00:00
15395 2 021410 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s029lbl.pdf
2011-11-16 00:00:00
15396 2 021410 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf
2014-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf
2014-05-12 00:00:00
15398 2 021411 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21411_strattera_lbl.pdf
2002-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021411s018lbl.pdf
2006-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021
lbl.pdf 2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf
2008-07-29 00:00:00
15402 2 021411 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf
2009-06-04 00:00:00
15403 2 021411 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021411s032lbl.pdf
2010-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s034lbl.pdf
2012-07-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf
2011-03-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s039lbl.pdf
2012-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s040lbl.pdf
2013-08-05 00:00:00
15408 2 021411 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s042lbl.pdf
2013-08-05 00:00:00
15409 2 021411 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021411s044lbl.pdf
2014-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s045lbl.pdf
2013-12-05 00:00:00
15411 2 021411 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s046lbl.pdf
2015-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s047lbl.pdf
2015-04-21 00:00:00
15413 2 021415 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021415s001lbl.pdf
2005-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf
2011-04-15 00:00:00
15415 2 021416 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf
2014-06-23 00:00:00
15416 2 021419 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.p
df 2007-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021419s004lbl.pdf
2010-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s006lbl.pdf
2013-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s007lbl.pdf
2013-12-17 00:00:00
15420 2 021425 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21425lbl.pdf 2002-
09-20 00:00:00
15421 2 021425 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021425s012lbl.pdf
2007-09-04 00:00:00
15422 2 021425 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021425s020lbl.pdf
2012-05-07 00:00:00
15423 14 021426 SUPPL 6 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15424 14 021426 SUPPL 8 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15425 14 021426 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15426 14 021426 SUPPL 18 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15427 2 021427 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21427lbl.pdf 2004-
08-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf
2007-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021427s012lbl.pdf
2006-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf
2007-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf
2007-12-03 00:00:00
15432 2 021427 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s018lbl.pdf
2007-08-03 00:00:00
15433 2 021427 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf
2009-03-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf
2009-03-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s029lbl.pdf
2009-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s036lbl.pdf
2011-04-15 00:00:00
15437 2 021427 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s039lbl.pdf
2011-09-07 00:00:00
15438 2 021427 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf
2012-10-22 00:00:00
15439 2 021427 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427Orig1s045lbl.pdf
2014-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021427s046lbl.pdf
2015-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf 2002-
08-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,0214
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.p
df 2011-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.p
df 2012-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021431s015lbl.pdf
2012-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021433s005lbl.pdf
2006-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s025lbl.pdf
2014-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf
2016-08-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021434s007lbl.pdf
2011-08-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21451_oraqix_lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021455s009lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21472slr001_ibuprofen_lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008,
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520_symbyax_lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021524lbl.pdf 2005-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s003lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021526s002lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021526s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021526s029lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21527lbl.pdf 2004-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021527s005lbl.pdf
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2011-05-05 00:00:00
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2011-05-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s024lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21535_clobex_lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535s002lbl.pdf
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15715 14 021536 SUPPL 28 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15716 14 021536 SUPPL 29 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15717 14 021536 SUPPL 33 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15718 14 021536 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15719 14 021536 SUPPL 39 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15720 14 021536 SUPPL 41 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15721 14 021536 SUPPL 44 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15722 14 021536 SUPPL 51 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15723 2 021537 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf
2015-12-15 00:00:00
15724 2 021539 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539_N-
acetylcysteine_lbl.pdf 2004-02-03 00:00:00
15725 2 021539 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr002_acetadote_lbl.
pdf 2004-05-04 00:00:00
15726 2 021539 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021539s012lbl.pdf
2013-06-11 00:00:00
15727 2 021540 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021540s006lbl.pdf
2006-08-29 00:00:00
15728 2 021540 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021540s018lbl.pdf
2009-07-23 00:00:00
15729 2 021540 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021540s019lbl.pdf
2010-02-23 00:00:00
15730 2 021540 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021540s030s031lbl.pdf
2013-11-13 00:00:00
15731 2 021540 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021540s034lbl.pdf
2014-05-28 00:00:00
15732 2 021540 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021540s036lbl.pdf
2015-03-27 00:00:00
15733 2 021540 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021540s037lbl.pdf
2015-03-27 00:00:00
15734 2 021543 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21543_striant_lbl.pdf
2003-06-22 00:00:00
15735 2 021543 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21543s002lbl.pdf
2004-11-08 00:00:00
15736 2 021543 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s010lbl.pdf
2014-06-23 00:00:00
15737 2 021544 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21544_seasonale_lbl.pdf
2003-09-25 00:00:00
15738 2 021545 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021545lbl.pdf 2004-
12-29 00:00:00
15739 2 021545 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s006lbl.pdf
2007-05-01 00:00:00
15740 2 021546 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21546_rebetol_lbl.pdf
2004-06-14 00:00:00
15741 2 021546 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.p
df 2013-06-04 00:00:00
15742 2 021546 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.p
df 2015-05-27 00:00:00
15743 2 021548 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21548_levixa_lbl.pdf
2003-10-27 00:00:00
15744 2 021548 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21548s002lbl.pdf
2004-12-03 00:00:00
15745 2 021548 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s004lbl.pdf
2005-06-14 00:00:00
15746 2 021548 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s005lbl.pdf
2005-11-17 00:00:00
15747 2 021548 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s007lbl.pdf
2006-03-14 00:00:00
15748 2 021548 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s009lbl.pdf
2006-08-09 00:00:00
15749 2 021548 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s010lbl.pdf
2007-02-21 00:00:00
15750 2 021548 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s011lbl.pdf
2006-11-16 00:00:00
15751 2 021548 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s013lbl.pdf
2007-10-15 00:00:00
15752 2 021548 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s014lbl.pdf
2007-12-14 00:00:00
15753 2 021548 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s015lbl.pdf
2007-12-27 00:00:00
15754 2 021548 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s016lbl.pdf
2008-02-25 00:00:00
15755 2 021548 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.p
df 2008-03-07 00:00:00
15756 2 021548 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.p
df 2009-09-18 00:00:00
15757 2 021548 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.p
df 2011-05-16 00:00:00
15758 2 021548 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.p
df 2012-05-01 00:00:00
15759 2 021548 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.p
df 2012-02-22 00:00:00
15760 2 021548 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.p
df 2013-02-14 00:00:00
15761 2 021548 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.p
df 2015-07-22 00:00:00
15762 2 021548 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.p
df 2016-03-23 00:00:00
15763 2 021549 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s009lbl.pdf
2005-06-14 00:00:00
15764 2 021549 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf
2006-07-03 00:00:00
15765 2 021549 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021549s012lbl.pdf
2007-11-19 00:00:00
15766 2 021549 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s016lbl.pdf
2009-02-04 00:00:00
15767 2 021549 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021549s017lbl.pdf
2010-03-26 00:00:00
15768 2 021549 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s023lbl.pdf
2013-04-01 00:00:00
15769 2 021549 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021549s024lbl.pdf
2014-08-13 00:00:00
15770 2 021549 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021549s025lbl.pdf
2015-09-03 00:00:00
15771 2 021551 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21551_halflytely_lbl.pdf
2004-05-27 00:00:00
15772 2 021551 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021551s005lbl.pdf
2006-05-22 00:00:00
15773 2 021551 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021551s013lbl.pdf
2010-07-19 00:00:00
15774 2 021555 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21555lbl.pdf 2002-
10-07 00:00:00
15775 2 021555 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027,
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15777 2 021560 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021560s006lbl.pdf
2013-02-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21563lbl.pdf 2004-
09-03 00:00:00
15779 2 021563 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,0213
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15780 2 021565 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf
2003-10-17 00:00:00
15781 2 021565 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf
2011-12-23 00:00:00
15782 2 021566 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021566s001lbl.pdf
2005-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567se2-
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15784 2 021567 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021567s005lbl.pdf
2005-07-21 00:00:00
15785 2 021567 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf
2006-08-11 00:00:00
15786 2 021567 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s014lbl.pdf
2008-01-08 00:00:00
15787 2 021567 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s018lbl.pdf
2008-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021567s019lbl.pdf
2009-11-23 00:00:00
15789 2 021567 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s025lbl.pdf
2011-02-09 00:00:00
15790 2 021567 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s028lbl.pdf
2012-03-16 00:00:00
15791 2 021567 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf
2013-08-21 00:00:00
15792 2 021567 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.p
df 2014-06-03 00:00:00
15793 2 021567 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.p
df 2015-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021569s004lbl.pdf
2012-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021571s006lbl.pdf
2014-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s008lbl.pdf
2006-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s009lbl.pdf
2006-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s010lbl.pdf
2007-02-21 00:00:00
15799 2 021572 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s011lbl.pdf
2007-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030
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15801 2 021572 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s033lbl.pdf
2010-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s037lbl.pdf
2012-05-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021572s038lbl.pdf
2011-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s040lbl.pdf
2012-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572Orig1s048lbledt.pdf
2015-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21574_fortamet_lbl.pdf
2004-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021574s006lbl.pdf
2007-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21575_fosomax_lbl.pdf
2003-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fo
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15811 2 021575 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.p
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15816 2 021575 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.p
df 2013-12-24 00:00:00
15817 2 021575 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.p
df 2015-12-01 00:00:00
15818 2 021583 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf 2004-
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15819 2 021583 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf
2005-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf
2007-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf
2009-07-16 00:00:00
15822 2 021583 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf
2015-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.p
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15825 2 021586 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021586Orig1s005lbl.pdf
2015-06-19 00:00:00
15826 2 021587 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21587_childrens_advil.pdf
2004-03-03 00:00:00
15827 2 021588 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf 2003-
04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf
2003-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf
2003-12-08 00:00:00
15830 2 021588 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf
2005-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf
2005-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf
2006-09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf
2009-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf
2012-01-31 00:00:00
15838 2 021588 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf
2015-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21590_fazaclo_lbl.pdf
2004-03-03 00:00:00
15840 2 021590 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s008lbl.pdf
2005-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s017lbl.pdf
2010-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s018lbl.pdf
2010-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021590s024lbl.pdf
2012-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21591slr001_riomet_lbl.pdf
2004-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021592s003lbl.pdf
2010-06-02 00:00:00
15847 2 021595 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21595_lbl.pdf 2004-
06-01 00:00:00
15848 2 021595 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21595s001lbl.pdf
2005-03-14 00:00:00
15849 2 021595 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021595s005lbl.pdf
2009-06-04 00:00:00
15850 2 021595 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021595s009lbl.pdf
2012-07-24 00:00:00
15851 14 021597 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15852 2 021598 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf
2003-04-17 00:00:00
15853 2 021598 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox
_lbl.pdf 2003-10-10 00:00:00
15854 2 021598 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pd
f 2004-05-03 00:00:00
15855 2 021602 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021602s010lbl.pdf
2006-12-08 00:00:00
15856 2 021602 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021602s013lbl.pdf
2007-10-10 00:00:00
15857 2 021602 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021602s023lbl.pdf
2010-12-04 00:00:00
15858 2 021602 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021602s029s030lbl.pdf
2011-11-04 00:00:00
15859 2 021602 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s031s032lbl.pdf
2012-10-26 00:00:00
15860 2 021602 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s038lbl.pdf
2014-08-12 00:00:00
15861 2 021604 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021604Orig1s004lbl.pdf
2014-08-06 00:00:00
15862 2 021605 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf
2014-03-10 00:00:00
15863 2 021606 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021606lbl.pdf 2005-
05-27 00:00:00
15864 2 021606 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021606s009lbl.pdf
2011-04-07 00:00:00
15865 2 021606 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021606s012s014lbl.pdf
2014-09-03 00:00:00
15866 2 021610 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.p
df 2006-08-04 00:00:00
15867 2 021610 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021610s003lbl.pdf
2007-07-10 00:00:00
15868 2 021610 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s005lbl.pdf
2008-01-18 00:00:00
15869 2 021610 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s006lbl.pdf
2008-03-05 00:00:00
15870 2 021610 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s012lbl.pdf
2012-07-12 00:00:00
15871 2 021610 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s013lbl.pdf
2012-07-13 00:00:00
15872 2 021611 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021611lbl.pdf 2006-
06-28 00:00:00
15873 2 021611 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021611s007lbl.pdf
2014-05-14 00:00:00
15874 2 021612 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021612lbl.pdf 2006-
01-24 00:00:00
15875 2 021612 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021612s007lbl.pdf
2011-10-31 00:00:00
15876 2 021612 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf
2013-01-23 00:00:00
15877 2 021615 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021615lbl.pdf 2004-
12-29 00:00:00
15878 2 021615 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,0216
15s008lbl.pdf 2012-03-06 00:00:00
15879 2 021615 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,0216
15s016lbl.pdf 2013-07-11 00:00:00
15880 2 021618 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21618_tindamax_lbl.pdf
2004-05-27 00:00:00
15881 2 021620 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21620_mucinex_lbl.pdf
2004-05-04 00:00:00
15882 2 021623 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021623lbl.pdf 2005-
06-24 00:00:00
15883 2 021623 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf
2014-03-11 00:00:00
15884 2 021625 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21625_MVI_Adult_lbl.pdf
2004-02-03 00:00:00
15885 2 021626 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021626s007lbl.pdf
2008-08-29 00:00:00
15886 2 021627 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021627s012lbl.pdf
2014-08-12 00:00:00
15887 14 021629 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15888 14 021629 SUPPL 8 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15889 14 021629 SUPPL 10 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15890 14 021629 SUPPL 29 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15891 2 021630 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr00
5,006,21630slr001_vfend_lbl.pdf 2004-05-04 00:00:00
15892 2 021630 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s
004lbl.pdf 2005-03-29 00:00:00
15893 2 021630 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_0216
30s005lbl.pdf 2005-07-08 00:00:00
15894 2 021630 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,0216
30s006lbl.pdf 2006-01-05 00:00:00
15895 2 021630 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,0212
66s015lbl.pdf 2006-03-22 00:00:00
15896 2 021630 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,0216
30s009lbl.pdf 2008-02-14 00:00:00
15897 2 021630 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021
267s025s029s032s033,021630s014s018s020s021lbl.pdf 2010-06-24 00:00:00
15898 2 021630 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021
267s025s029s032s033,021630s014s018s020s021lbl.pdf 2010-06-24 00:00:00
15899 2 021630 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,0216
30s022lbl.pdf 2010-12-26 00:00:00
15900 2 021630 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,0216
30s026lbl.pdf 2011-11-21 00:00:00
15901 2 021632 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.p
df 2006-02-28 00:00:00
15902 2 021632 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf
2006-08-09 00:00:00
15903 2 021632 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf
2006-11-16 00:00:00
15904 2 021633 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021633s005lbl.pdf
2014-08-13 00:00:00
15905 2 021636 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf
2004-06-16 00:00:00
15906 2 021636 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s008lbl.pdf
2010-08-05 00:00:00
15907 2 021636 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,0218
50s003,022456s002lbl.pdf 2010-09-10 00:00:00
15908 2 021636 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.p
df 2012-04-20 00:00:00
15909 2 021636 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pd
f 2014-12-29 00:00:00
15910 2 021641 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007
s008s010lbl.pdf 2009-12-10 00:00:00
15911 2 021641 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007
s008s010lbl.pdf 2009-12-10 00:00:00
15912 2 021641 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007
s008s010lbl.pdf 2009-12-10 00:00:00
15913 2 021641 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf
2014-05-30 00:00:00
15914 2 021642 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021642lbl.pdf 2005-
02-03 00:00:00
15915 2 021642 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021642s020lbl.pdf
2014-06-10 00:00:00
15916 2 021644 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21644_clobex_lbl.pdf
2004-03-03 00:00:00
15917 2 021644 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003,
021644Orig1s003lbl.pdf 2014-01-14 00:00:00
15920 2 021648 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021648s008lbl.pdf
2015-07-30 00:00:00
15921 2 021652 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021652s003lbl.pdf
2006-08-14 00:00:00
15922 2 021652 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s015lbl.pdf
2012-03-12 00:00:00
15923 2 021652 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s021lbl.pdf
2015-10-07 00:00:00
15924 2 021654 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf 2004-
11-16 00:00:00
15925 2 021654 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s021lblR.pdf
2008-06-19 00:00:00
15926 2 021654 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf
2009-09-21 00:00:00
15927 2 021654 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021654s030lbl.pdf
2010-12-26 00:00:00
15928 2 021654 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf
2013-09-17 00:00:00
15929 2 021654 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf
2014-05-14 00:00:00
15930 2 021656 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21656lbl.pdf 2004-
11-08 00:00:00
15931 2 021656 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021656s019lbl.pdf
2010-10-21 00:00:00
15932 2 021656 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s020lbl.pdf
2011-09-23 00:00:00
15933 2 021656 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021656s023lbl.pdf
2013-02-06 00:00:00
15934 2 021658 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf
2012-11-26 00:00:00
15935 2 021660 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf
2012-01-26 00:00:00
15936 2 021660 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf
2012-10-04 00:00:00
15937 2 021660 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s036lbl.pdf
2013-06-11 00:00:00
15938 2 021660 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021660s040lbl.pdf
2015-01-08 00:00:00
15939 2 021663 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21663lbl.pdf 2020-
03-23 00:00:00
15940 14 021663 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15941 14 021663 SUPPL 14 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
15942 2 021664 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf 2005-
03-29 00:00:00
15943 2 021664 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf
2006-01-27 00:00:00
15944 2 021664 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
2014-01-28 00:00:00
15945 2 021664 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
2014-01-28 00:00:00
15946 2 021665 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf 2020-
03-23 00:00:00
15947 2 021665 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf
2020-03-23 00:00:00
15948 2 021667 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21677_nutreStore_lbl.pdf
2004-08-19 00:00:00
15949 2 021667 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021667s003lbl.pdf
2011-03-21 00:00:00
15950 2 021669 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021669s003lbl.pdf
2006-08-18 00:00:00
15951 2 021669 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021669Orig1s019lbl.pdf
2014-07-31 00:00:00
15952 2 021670 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021670lbl.pdf 2004-
12-30 00:00:00
15953 2 021671 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s014_LBL.pdf
2007-01-18 00:00:00
15954 2 021671 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s015lbl.pdf
2007-02-23 00:00:00
15955 2 021673 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf
2011-06-14 00:00:00
15956 2 021673 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf
2014-09-19 00:00:00
15957 2 021673 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf
2015-12-17 00:00:00
15958 2 021674 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21674_menostar_lbl.pdf
2004-06-10 00:00:00
15959 2 021676 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021676s000lbl.pdf
2006-03-22 00:00:00
15960 2 021676 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021676s008lbl.pdf
2011-03-14 00:00:00
15961 2 021676 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf
2010-04-16 00:00:00
15962 2 021676 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021676s014lbl.pdf
2015-06-04 00:00:00
15963 2 021684 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf
2020-03-23 00:00:00
15964 2 021687 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21687lbl.pdf 2004-
07-28 00:00:00
15965 2 021687 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s004lbl.pdf
2005-10-24 00:00:00
15966 2 021687 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf
2006-03-22 00:00:00
15967 2 021687 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s011lbl.pdf
2006-10-05 00:00:00
15968 2 021687 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s016lbl.pdf
2006-12-04 00:00:00
15969 2 021687 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s019lbl.pdf
2007-05-29 00:00:00
15970 2 021687 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s021lbl.pdf
2007-12-14 00:00:00
15971 2 021687 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s029lbl.pdf
2009-01-14 00:00:00
15972 2 021687 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s030lbl.pdf
2009-02-04 00:00:00
15973 2 021687 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s032lbl.pdf
2009-11-23 00:00:00
15974 2 021687 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf
2011-06-08 00:00:00
15975 2 021687 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s034lbl.pdf
2010-03-17 00:00:00
15976 2 021687 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s037lbl.pdf
2010-12-26 00:00:00
15977 2 021687 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf
2011-06-08 00:00:00
15978 2 021687 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s041lbl.pdf
2011-10-12 00:00:00
15979 2 021687 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s042lbl.pdf
2011-12-02 00:00:00
15980 2 021687 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s044lbl.pdf
2012-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021687s053lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s006lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s027lbl.pdf
2014-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s028lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690lbl.pdf 2005-
05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,0216
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021692lbl.pdf 2005-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021692s002lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021692s005s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021693lbl.pdf 2005-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s004lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021695lbl.pdf 2004-
12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021695s006lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021695s009lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021695s012lbl.pdf
2015-09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18731s43ltr.pdf
2001-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018731s048ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018733s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018735Orig1s054ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18738slr007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018741s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s016ltr.pdf
2006-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18748slr010ltr.pdf
2003-03-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018751Orig1s023ltr.pdf
2014-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18754slr026ltr.pdf
2003-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018754s027_019816s010l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18760s026ltr.pdf
2005-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018760s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18761s16ltr.pdf
2002-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018766s014ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018766s015ltr.pdf
2010-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018771s017ltr.pdf
2008-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018776s030ltr.pdf
2010-11-29 00:00:00
16039 14 018780 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16040 14 018780 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16041 14 018780 SUPPL 114 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16042 14 018780 SUPPL 128 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16043 14 018780 SUPPL 132 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16044 14 018780 SUPPL 150 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16045 14 018780 SUPPL 152 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16046 14 018781 SUPPL 70 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16047 14 018781 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16048 14 018781 SUPPL 88 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16049 14 018781 SUPPL 89 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16050 14 018781 SUPPL 108 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16051 14 018781 SUPPL 118 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16052 14 018781 SUPPL 144 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16053 14 018781 SUPPL 145 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16054 14 018781 SUPPL 156 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18800slr014ltr.pdf
2003-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18801scs023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018801s034ltr.pdf
2009-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018814s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018817s021ltr.pdf
2009-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018817Orig1s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18826S27ltr.pdf
2003-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18827s22ltr.pdf
2003-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018829Orig1s022ltr.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018840s028ltr.pdf
2005-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf
2002-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18841slr020ltr.pdf
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018841s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018841Orig1s028ltr.pdf
2016-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018849Orig1s020ltr.pdf
2014-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018869s014ltr.pdf
2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018874s019_ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf
2003-05-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018878s023ltr.pdf
2006-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018878s027ltr.pdf
2010-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18883scs028,20171scs01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018883Orig1s044,020171
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018890Orig1s050ltr.pdf
2015-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018891s024ltr.pdf
2006-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018891s027ltr.pdf
2010-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018891s028ltr.pdf
2012-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18895scs013ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18897s16ltr.pdf
2002-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s027ltr.pdf
2016-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018905Orig1s024ltr.pdf
2015-07-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018916s057ltr.pdf
2011-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018917s024_ltr.pdf
2007-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018917s025ltr.pdf
2011-03-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018921Orig1s031ltr.pdf
2015-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018922s021ltr.pdf
2005-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018922s022_020584s009l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018922s023ltr.pdf
2007-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018925s007,019038s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,01828
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18936se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18936s067ltr.pdf
2002-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235
Orig1s018ltr.pdf 2011-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,0
21235Orig1s019,s020ltr.pdf 2013-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936
Origs102ltr.pdf 2014-10-15 00:00:00
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Orig1s105,021235Orig1s024ltr.pdf 2014-07-24 00:00:00
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2015-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038,
018938s027, 019955s013ltr.pdf 2007-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18956s065ltr.pdf
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2002-12-06 00:00:00
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018164s055, 017581s105ltr.pdf 2006-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_
018164s056ltr.pdf 2006-01-30 00:00:00
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018164s057, 018965s015, 020067s013_ltr.pdf 2007-04-25 00:00:00
16140 1 018965 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164
Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf 2013-03-26 00:00:00
16141 1 018965 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018965Orig1s022.s023lt
r.pdf 2016-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18969scs012ltr.pdf
2003-03-26 00:00:00
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1999-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s39ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018972s044ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018972Orig1s047ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018983Orig1s047ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s060ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018989s067ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018989s073ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18991scs025,18997scs02
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-
998S059_Vasotec_Approv.pdf 2001-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18998scm063ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998Origs077ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/019010s036,019732s037,02051
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19011slr015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019011Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19012S16LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019012s046ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19018scs018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019028s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19032s16s17ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019032Orig1s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019034s012LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019057s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019071s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019079s024LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019081s042ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection_appro
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19090s45ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s053,019593s042l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019111s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019111s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019111Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19123slr022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019123s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019125s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019125Orig1s042ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019127s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19152scs030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019152s035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019152Orig1s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19155slr019,020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019183s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019183s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019183s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019201s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019211s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019216s021s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021697s002lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021697s003lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s018lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s019lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,0217
00s010lbl.pdf 2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021703lbl.pdf 2006-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033,
021704Orig1s017lbl.pdf 2015-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1
s018lbl.pdf 2016-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000l
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021710s009lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021711s004lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl
.pdf 2005-03-03 00:00:00
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df 2012-02-22 00:00:00
16370 2 021785 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.p
df 2015-04-02 00:00:00
16371 2 021785 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-
021785s19lbl.pdf 2015-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021788lbl.pdf 2008-
12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789s001lbl.pdf
2005-11-18 00:00:00
16374 2 021789 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021789s003lbl.pdf
2010-03-17 00:00:00
16375 2 021789 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021789s004lbl.pdf
2011-11-04 00:00:00
16376 2 021790 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021790lbl.pdf 2006-
05-04 00:00:00
16377 2 021790 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021790s018lbl.pdf
2015-09-04 00:00:00
16378 2 021793 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.p
df 2009-09-22 00:00:00
16379 2 021793 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008lbl.pdf
2010-11-26 00:00:00
16380 2 021797 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.p
df 2007-03-31 00:00:00
16381 2 021797 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.p
df 2007-07-27 00:00:00
16382 2 021797 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.p
df 2008-08-13 00:00:00
16383 2 021797 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s
016lbl.pdf 2012-10-15 00:00:00
16384 2 021798 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf
2005-03-31 00:00:00
16385 2 021798 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.p
df 2007-03-31 00:00:00
16386 2 021798 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008,
021798s008lbl.pdf 2009-07-24 00:00:00
16387 2 021798 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.p
df 2009-03-17 00:00:00
16388 2 021798 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s010,021798s011lbl.p
df 2010-10-29 00:00:00
16389 2 021798 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s
016lbl.pdf 2012-10-15 00:00:00
16390 2 021798 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.p
df 2013-12-23 00:00:00
16391 2 021798 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.p
df 2014-03-25 00:00:00
16392 2 021799 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021799lbl.pdf 2005-
08-15 00:00:00
16393 2 021799 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021799s006lbl.pdf
2007-10-10 00:00:00
16394 2 021799 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021799s008lbl.pdf
2008-11-17 00:00:00
16395 2 021799 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021799s011lbl.pdf
2010-06-24 00:00:00
16396 2 021799 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021799s016lbl.pdf
2011-04-18 00:00:00
16397 2 021799 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021799s024lbl.pdf
2014-07-03 00:00:00
16398 2 021802 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021802lbl.pdf 2005-
06-07 00:00:00
16399 2 021802 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf
2006-04-12 00:00:00
16400 2 021802 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf
2006-08-04 00:00:00
16401 2 021802 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf
2009-10-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s017lbl.pdf
2010-05-07 00:00:00
16403 2 021802 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf
2010-11-19 00:00:00
16404 2 021802 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021802s024lbl.pdf
2012-05-07 00:00:00
16405 2 021802 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.p
df 2015-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lbl.pdf 2005-
11-01 00:00:00
16407 2 021810 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf 2020-
03-23 00:00:00
16408 14 021810 SUPPL 10 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16409 2 021812 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021812Orig1s009lbl.pdf
2014-03-27 00:00:00
16410 2 021812 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021812Orig1s011lbl.pdf
2015-02-17 00:00:00
16411 2 021813 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021813lbl.pdf 2006-
12-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021813s004lbl.pdf
2014-03-04 00:00:00
16413 2 021814 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf
2006-08-14 00:00:00
16414 2 021814 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021814s003lbl.pdf
2007-10-10 00:00:00
16415 2 021814 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s009lbl.pdf
2010-08-16 00:00:00
16416 2 021814 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021814s011lbl.pdf
2011-04-06 00:00:00
16417 2 021817 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s001lbl.pdf
2008-06-19 00:00:00
16418 2 021817 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s012lbl.pdf
2011-09-01 00:00:00
16419 2 021817 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021817s015lbl.pdf
2013-04-23 00:00:00
16420 2 021821 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021821lbl.pdf 2005-
06-17 00:00:00
16421 2 021821 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf
2009-03-25 00:00:00
16422 2 021821 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s016lbl.pdf
2009-02-10 00:00:00
16423 2 021821 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf
2009-03-25 00:00:00
16424 2 021821 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf
2009-02-04 00:00:00
16425 2 021821 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s039lbl.pdf
2016-06-01 00:00:00
16426 2 021823 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019,
021823s002lbl.pdf 2006-01-25 00:00:00
16427 2 021823 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf
2011-01-26 00:00:00
16428 2 021823 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021823s009lbl.pdf
2013-04-23 00:00:00
16429 2 021829 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829lbl.pdf 2007-
05-10 00:00:00
16430 2 021829 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021829s007lbl.pdf
2015-03-02 00:00:00
16431 2 021830 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf
2016-05-06 00:00:00
16432 2 021835 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021835lbl.pdf 2005-
11-01 00:00:00
16433 2 021835 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s006lbl.pdf
2012-09-11 00:00:00
16434 2 021835 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s007lbl.pdf
2012-08-20 00:00:00
16435 2 021839 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf 2020-
03-23 00:00:00
16436 14 021839 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16437 14 021839 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
16438 2 021840 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021840lbl.pdf 2006-
05-26 00:00:00
16439 2 021842 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021842s001lbl.pdf
2006-09-01 00:00:00
16440 2 021842 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s007lbl.pdf
2009-01-06 00:00:00
16441 2 021842 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf
2012-05-22 00:00:00
16442 2 021842 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s011lbl.pdf
2009-10-23 00:00:00
16443 2 021842 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf
2011-08-04 00:00:00
16444 2 021844 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021844lbl.pdf 2006-
10-23 00:00:00
16445 2 021844 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021844s002lbl.pdf
2010-01-12 00:00:00
16446 2 021844 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021844s008lbl.pdf
2014-07-24 00:00:00
16447 2 021845 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021845s004lbl.pdf
2007-12-27 00:00:00
16448 2 021845 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s006lbl.pdf
2009-05-11 00:00:00
16449 2 021845 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.p
df 2010-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s
006,203109s003s004lbl.pdf 2014-02-03 00:00:00
16451 2 021849 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,0218
50s003,022456s002lbl.pdf 2010-09-10 00:00:00
16452 2 021849 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.p
df 2011-05-25 00:00:00
16453 2 021849 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.p
df 2012-11-15 00:00:00
16454 2 021849 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.p
df 2012-04-20 00:00:00
16455 2 021849 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pd
f 2014-12-29 00:00:00
16456 2 021850 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,0218
50s003,022456s002lbl.pdf 2010-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s015lbl.pdf
2015-01-08 00:00:00
16458 2 021852 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s016lbl.pdf
2014-07-29 00:00:00
16459 2 021856 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021856lbl.pdf 2009-
02-20 00:00:00
16460 2 021856 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021856s003lbl.pdf
2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021856s006lbl.pdf
2012-11-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s000lbl.pdf
2006-01-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s001lbl.pdf
2006-08-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009lbl.pdf
2011-01-26 00:00:00
16465 2 021858 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf
2013-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021859lbl.pdf 2020-
03-23 00:00:00
16467 2 021859 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021859s005lbl.pdf
2020-03-23 00:00:00
16468 2 021859 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021859s006lbl.pdf
2020-03-23 00:00:00
16469 2 021859 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s009lbl.pdf
2020-03-23 00:00:00
16470 2 021859 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s015lbl.pdf
2020-03-23 00:00:00
16471 2 021860 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s001lbl.pdf
2007-04-09 00:00:00
16472 2 021860 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.
pdf 2013-07-08 00:00:00
16473 2 021860 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.
pdf 2013-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021860s010lbl.pdf
2014-12-03 00:00:00
16475 2 021861 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021861s011lbl.pdf
2015-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021862lbl.pdf 2005-
08-23 00:00:00
16477 2 021862 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf
2011-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021864lbl.pdf 2007-
05-29 00:00:00
16479 2 021864 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021864s002lbl.pdf
2008-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713
s10,021436s16lbl.pdf 2010-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,2172
9s004,021866s004lbl.pdf 2007-11-07 00:00:00
16483 2 021866 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,0217
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16485 2 021866 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,0217
29s022,021866s023lbl.pdf 2014-12-15 00:00:00
16488 2 021870 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021870s005lbl.pdf
2011-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021870s007lbl.pdf
2012-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021871lbl.pdf 2006-
02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf
2007-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021872s005lbl.pdf
2012-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf
2013-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s015lbl.pdf
2014-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s016lbl.pdf
2014-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s021lbl.pdf
2016-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021873lbl.pdf 2006-
10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
2010-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
2010-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
2010-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf
2015-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.p
df 2011-05-25 00:00:00
16778 2 022020 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.p
df 2012-10-15 00:00:00
16779 2 022020 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022020s007lbl.pdf
2012-05-15 00:00:00
16780 2 022020 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.p
df 2013-12-11 00:00:00
16781 2 022021 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022021s007lbl.pdf
2011-08-12 00:00:00
16782 2 022021 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022021s008lbl.pdf
2012-01-23 00:00:00
16783 2 022023 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022023lbl.pdf 2008-
01-30 00:00:00
16784 2 022023 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf
2010-03-26 00:00:00
16785 2 022023 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf
2013-03-26 00:00:00
16786 2 022023 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022023s009lbl.pdf
2012-07-10 00:00:00
16787 2 022023 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022023s011lbl.pdf
2014-08-13 00:00:00
16788 2 022024 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022024s001lbl.pdf
2013-11-14 00:00:00
16789 2 022024 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf
2010-12-26 00:00:00
16790 2 022024 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf
2011-08-04 00:00:00
16791 2 022025 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022025lbl.pdf 2007-
09-10 00:00:00
16792 2 022025 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s005lbl.pdf
2009-09-21 00:00:00
16793 2 022026 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022026lbl.pdf 2007-
10-04 00:00:00
16794 2 022027 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s
003lbl.pdf 2012-06-22 00:00:00
16795 2 022028 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022028lbl.pdf 2008-
02-25 00:00:00
16796 2 022029 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022029s003lbl.pdf
2009-06-29 00:00:00
16797 2 022029 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022029Orig1s014lbl.pdf
2014-02-14 00:00:00
16798 2 022030 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022030lbl.pdf 2008-
11-07 00:00:00
16799 2 022030 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s006lbl.pdf
2011-11-18 00:00:00
16800 2 022030 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s007lbl.pdf
2011-02-11 00:00:00
16801 2 022030 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022030s009lbl.pdf
2012-08-02 00:00:00
16802 2 022032 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.pdf
2009-07-24 00:00:00
16803 2 022032 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022032Orig1s020lbl.pdf
2014-01-15 00:00:00
16804 2 022032 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s029lbll.pdf
2015-06-19 00:00:00
16805 2 022033 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022033lbl.pdf 2008-
03-05 00:00:00
16806 2 022033 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s003lbl.pdf
2011-05-09 00:00:00
16807 2 022033 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s006lbl.pdf
2011-05-09 00:00:00
16808 2 022033 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s007lbl.pdf
2011-05-09 00:00:00
16809 2 022037 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s008lbl.pdf
2013-02-21 00:00:00
16810 2 022037 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022037s011lbl.pdf
2015-03-19 00:00:00
16811 2 022037 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022037s013lbl.pdf
2016-07-08 00:00:00
16812 2 022038 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022038lbl.pdf 2007-
06-07 00:00:00
16813 2 022041 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022041lbl.pdf 2006-
12-19 00:00:00
16814 2 022041 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022041s005lbl.pdf
2009-06-10 00:00:00
16815 2 022041 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s007lbl.pdf
2010-03-03 00:00:00
16816 2 022041 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf
2011-04-11 00:00:00
16817 2 022042 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf 2007-
09-14 00:00:00
16818 2 022043 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022043lbl.pdf 2007-
05-01 00:00:00
16819 2 022044 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022044lbl.pdf 2007-
04-06 00:00:00
16820 2 022044 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf
2008-01-08 00:00:00
16821 2 022044 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf
2008-01-08 00:00:00
16822 2 022044 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf
2010-03-02 00:00:00
16823 2 022044 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf
2010-03-02 00:00:00
16824 2 022044 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf
2011-04-18 00:00:00
16825 2 022044 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf
2011-05-16 00:00:00
16826 2 022044 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf
2010-09-29 00:00:00
16827 2 022044 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s022lbl.pdf
2012-03-27 00:00:00
16828 2 022044 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s026lbl.pdf
2012-10-22 00:00:00
16829 2 022046 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022046s004lbl.pdf
2012-01-30 00:00:00
16830 2 022047 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf
2008-11-07 00:00:00
16831 2 022047 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf
2008-11-07 00:00:00
16832 2 022047 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s013lbl.pdf
2008-08-29 00:00:00
16833 2 022047 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022
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16834 2 022047 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022
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16835 2 022047 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.
pdf 2013-05-01 00:00:00
16836 2 022047 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf
2011-07-12 00:00:00
16837 2 022047 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.
pdf 2013-05-01 00:00:00
16838 2 022047 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s034lbl.pdf
2013-10-31 00:00:00
16839 2 022047 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022047s036lbl.pdf
2016-05-25 00:00:00
16840 2 022047 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022047s038lbl.pdf
2016-06-21 00:00:00
16847 2 022052 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022052lbl.pdf 2007-
06-04 00:00:00
16848 2 022052 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.p
df 2009-08-28 00:00:00
16849 2 022055 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf 2007-
04-20 00:00:00
16850 2 022055 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf
2010-10-07 00:00:00
16851 2 022056 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf 2008-
03-24 00:00:00
16852 2 022056 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pd
f 2008-12-04 00:00:00
16853 2 022056 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.p
df 2010-09-10 00:00:00
16854 2 022056 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbled
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16855 2 022056 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.p
df 2012-10-12 00:00:00
16856 2 022056 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf
2012-10-01 00:00:00
16857 2 022056 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.p
df 2014-04-01 00:00:00
16858 2 022056 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.p
df 2014-02-27 00:00:00
16859 2 022058 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022058s006lbl.pdf
2011-11-18 00:00:00
16860 2 022058 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022058s009lbl.pdf
2012-04-06 00:00:00
16861 2 022059 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s001lbl.pdf
2007-05-01 00:00:00
16862 2 022059 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf
2010-02-01 00:00:00
16863 2 022059 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022059s004lbl.pdf
2008-07-09 00:00:00
16864 2 022059 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf
2010-02-01 00:00:00
16865 2 022059 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf
2011-08-12 00:00:00
16866 2 022059 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf
2013-06-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf
2013-06-25 00:00:00
16868 2 022059 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022059Orig1s021lbl.pdf
2015-01-05 00:00:00
16869 2 022064 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022064lbl.pdf 2008-
04-09 00:00:00
16870 2 022064 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s005lbl.pdf
2008-02-14 00:00:00
16871 2 022064 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s009lbl.pdf
2008-04-01 00:00:00
16872 2 022064 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.p
df 2011-03-07 00:00:00
16873 2 022065 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022065lbl.pdf 2007-
10-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf
2009-10-07 00:00:00
16875 2 022065 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf
2009-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022066lbl.pdf 2007-
09-07 00:00:00
16877 2 022066 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022066s002lbl.pdf
2010-12-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf
2013-08-28 00:00:00
16879 2 022066 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.p
df 2014-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067lbl.pdf 2008-
01-18 00:00:00
16881 2 022067 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s001lbl.pdf
2008-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022067s004lbl.pdf
2010-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022067s007lbl.pdf
2011-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf 2007-
10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s001lbl.pdf
2010-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022068s002lbl.pdf
2009-09-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf
2010-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s007lbl.pdf
2011-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf
2011-11-25 00:00:00
16890 2 022068 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s011lbledt2.pdf
2012-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s017lbl.pdf
2014-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022070s003lbl.pdf
2014-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022071s004lbl.pdf
2011-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022071s007lbl.pdf
2012-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022072lbl.pdf 2006-
07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022074lbl.pdf 2007-
09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022074s003lbl.pdf
2011-03-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s004lbledt.pdf
2014-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022074s006lbl.pdf
2013-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf
2015-01-09 00:00:00
16901 2 022074 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf
2014-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022076lbl.pdf 2007-
05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022080lbl.pdf 2007-
08-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s002lbl.pdf
2008-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s010lbl.pdf
2009-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf
2009-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf
2012-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s030lbl.pdf
2014-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022081s033lbl.pdf
2015-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022083lbl.pdf 2007-
07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022083s008lbl.pdf
2010-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022083s016lbl.pdf
2012-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022083s020lbl.pdf
2015-02-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088lbl.pdf 2007-
06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088s001lbl.pdf
2007-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s006lbl.pdf
2010-04-28 00:00:00
16923 2 022088 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s008lbl.pdf
2010-07-12 00:00:00
16924 2 022088 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s017lbl.pdf
2014-10-09 00:00:00
16925 2 022088 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022088s018lbl.pdf
2015-03-02 00:00:00
16926 2 022088 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022088s019lbl.pdf
2016-07-28 00:00:00
16927 2 022100 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf
2011-05-23 00:00:00
16928 2 022100 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s019lbl.pdf
2012-10-02 00:00:00
16929 2 022100 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s026lbl.pdf
2014-09-26 00:00:00
16930 2 022101 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,0221
01s001lbl.pdf 2009-01-16 00:00:00
16931 2 022101 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,0221
01s009lbl.pdf 2012-10-12 00:00:00
16932 2 022101 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,0221
01s012lbl.pdf 2014-04-01 00:00:00
16933 2 022101 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,0221
01s013lbl.pdf 2014-02-27 00:00:00
16934 2 022102 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022102s000lbl.pdf
2007-08-01 00:00:00
16935 2 022102 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf
2009-03-25 00:00:00
16936 2 022104 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s002lbl.pdf
2009-04-03 00:00:00
16937 2 022104 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s003lbl.pdf
2009-02-04 00:00:00
16938 2 022104 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s008lbl.pdf
2012-05-07 00:00:00
16939 2 022104 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s009lbl.pdf
2012-12-13 00:00:00
16940 2 022106 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022106lbl.pdf 2007-
10-15 00:00:00
16941 2 022106 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf
2009-04-23 00:00:00
16942 2 022106 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s008lbl.pdf
2013-04-15 00:00:00
16943 2 022106 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022106s011lbl.pdf
2012-01-31 00:00:00
16944 2 022106 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022106s012lbl.pdf
2014-01-22 00:00:00
16945 2 022106 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf
2013-04-15 00:00:00
16946 2 022107 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022107s002lbl.pdf
2009-07-24 00:00:00
16947 2 022107 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s007lbl.pdf
2010-08-09 00:00:00
16948 2 022107 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s014lbl.pdf
2011-10-20 00:00:00
16949 2 022107 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s022lbl.pdf
2012-10-01 00:00:00
16950 2 022107 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022107s024lbl.pdf
2014-03-19 00:00:00
16951 2 022107 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s025lbl.pdf
2015-04-02 00:00:00
16952 2 022108 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022108lbl.pdf 2008-
05-27 00:00:00
16953 2 022108 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s003lbl.pdf
2011-05-02 00:00:00
16954 2 022108 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf
2011-07-27 00:00:00
16955 2 022108 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022108s007lbl.pdf
2012-08-15 00:00:00
16956 2 022108 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s011lbl.pdf
2014-07-11 00:00:00
16957 2 022110 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.p
df 2013-06-25 00:00:00
16958 2 022110 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s007lbl.pdf
2014-02-10 00:00:00
16959 2 022110 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s009lbl.pdf
2014-03-19 00:00:00
16960 2 022110 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s011lbl.pdf
2014-12-10 00:00:00
16961 2 022110 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022110s012lbl.pdf
2016-05-09 00:00:00
16962 2 022114 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022114lbl.pdf 2007-
08-17 00:00:00
16963 2 022114 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022114s001lbl.pdf
2009-01-14 00:00:00
16964 2 022115 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf
2015-01-08 00:00:00
16965 2 022115 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf
2010-04-19 00:00:00
16966 2 022115 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf
2010-10-26 00:00:00
16967 2 022115 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf
2015-01-08 00:00:00
16968 2 022115 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s015lbl.pdf
2011-06-29 00:00:00
16969 2 022115 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022115s017lbl.pdf
2012-08-02 00:00:00
16970 2 022115 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf
2015-03-25 00:00:00
16971 2 022116 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022116lbl.pdf 2007-
06-18 00:00:00
16972 2 022116 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.p
df 2008-03-07 00:00:00
16973 2 022116 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.p
df 2009-09-18 00:00:00
16974 2 022116 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.p
df 2011-05-16 00:00:00
16975 2 022116 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.p
df 2015-04-02 00:00:00
16976 2 022116 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.p
df 2016-03-23 00:00:00
16977 2 022117 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022117s000lbl.pdf
2009-08-26 00:00:00
16978 2 022117 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf
2010-08-30 00:00:00
16979 2 022117 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s007lbl.pdf
2010-12-04 00:00:00
16980 2 022117 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s011lbl.pdf
2014-10-24 00:00:00
16981 2 022117 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022117s012lbl.pdf
2013-03-26 00:00:00
16982 2 022117 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022117s013lbl.pdf
2012-11-08 00:00:00
16983 2 022117 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf
2014-11-20 00:00:00
16984 2 022117 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf
2014-11-20 00:00:00
16985 2 022117 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf
2015-03-17 00:00:00
16986 2 022118 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022118s005lbl.pdf
2012-11-06 00:00:00
16987 2 022122 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022122lbl.pdf 2007-
10-22 00:00:00
16988 2 022122 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022122s007lbl.pdf
2015-01-05 00:00:00
16989 2 022122 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf
2016-05-11 00:00:00
16990 2 022124 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022124lbl.pdf 2007-
11-26 00:00:00
16991 2 022127 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022127lbl.pdf 2007-
10-22 00:00:00
16992 2 022127 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022318s003,022127s008lbl.p
df 2011-06-16 00:00:00
16993 2 022127 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022127s011lbl.pdf
2014-12-17 00:00:00
16994 2 022127 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.p
df 2016-03-14 00:00:00
16995 2 022128 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf 2007-
08-07 00:00:00
16996 2 022128 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022128s002lbl.pdf
2009-11-23 00:00:00
16997 2 022128 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022128s004lbl.pdf
2010-06-03 00:00:00
16998 2 022128 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s010lbl.pdf
2013-02-06 00:00:00
16999 2 022128 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022128s015lbl.pdf
2015-05-11 00:00:00
17000 2 022129 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022129s002lbl.pdf
2010-06-24 00:00:00
17001 2 022134 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf
2015-10-07 00:00:00
17002 2 022137 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022137s003lbl.pdf
2011-02-24 00:00:00
17003 2 022145 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022145lbl.pdf 2007-
10-15 00:00:00
17004 2 022145 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf
2009-02-04 00:00:00
17005 2 022145 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s006lbl.pdf
2009-01-14 00:00:00
17006 2 022145 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf
2010-07-06 00:00:00
17007 2 022145 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s013lbl.pdf
2009-11-23 00:00:00
17008 2 022145 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s014lbl.pdf
2010-04-04 00:00:00
17009 2 022145 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s020lbl.pdf
2011-11-16 00:00:00
17010 2 022145 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.p
df 2012-04-20 00:00:00
17011 2 022145 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.p
df 2013-07-03 00:00:00
17012 2 022145 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s029lbl.pdf
2013-08-05 00:00:00
17013 2 022145 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,2057
86s001lbl.pdf 2014-04-10 00:00:00
17014 2 022145 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205
786s002lbl.pdf 2015-02-20 00:00:00
17015 2 022150 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022150s000lbl.pdf
2011-08-26 00:00:00
17016 2 022150 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022150s004lbl.pdf
2013-09-09 00:00:00
17017 2 022150 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s006lbl.pdf
2015-08-11 00:00:00
17018 2 022150 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.pdf
2015-11-25 00:00:00
17019 2 022152 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf
2013-03-01 00:00:00
17020 2 022152 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf
2013-03-01 00:00:00
17021 2 022152 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s005lbl.pdf
2013-06-18 00:00:00
17022 2 022152 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s007lbl.pdf
2014-09-03 00:00:00
17023 2 022154 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.p
df 2010-03-09 00:00:00
17024 2 022154 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.p
df 2010-10-04 00:00:00
17025 2 022154 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.p
df 2011-04-01 00:00:00
17026 2 022154 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013,022154s010lbl.p
df 2013-02-12 00:00:00
17027 2 022155 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf
2014-05-19 00:00:00
17028 2 022157 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157lbl.pdf 2008-
01-30 00:00:00
17029 2 022157 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157s001lbl.pdf
2008-06-30 00:00:00
17030 2 022157 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.p
df 2009-10-06 00:00:00
17031 2 022157 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.p
df 2011-03-07 00:00:00
17032 2 022157 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.p
df 2013-11-08 00:00:00
17033 2 022157 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.p
df 2016-06-27 00:00:00
17034 2 022159 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022159s011lbl.pdf
2016-03-22 00:00:00
17035 2 022161 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022161lbl.pdf 2008-
04-16 00:00:00
17036 2 022161 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf
2011-09-29 00:00:00
17037 2 022161 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s009lbl.pdf
2011-09-30 00:00:00
17038 2 022161 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf
2014-01-10 00:00:00
17039 2 022172 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022172lbl.pdf 2007-
11-19 00:00:00
17040 2 022173 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022173lbl.pdf 2009-
12-15 00:00:00
17041 2 022173 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s002lbl.pdf
2010-05-07 00:00:00
17042 2 022173 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s009lbl.pdf
2010-12-04 00:00:00
17043 2 022173 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf
2012-08-06 00:00:00
17044 2 022173 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022173s017lbl.pdf
2015-07-24 00:00:00
17045 2 022173 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022173s018lbl.pdf
2013-04-01 00:00:00
17046 14 022175 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17047 2 022180 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022180s010lbl.pdf
2013-12-24 00:00:00
17048 2 022180 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf
2015-03-19 00:00:00
17049 2 022181 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022181lbl.pdf 2007-
12-13 00:00:00
17050 2 022184 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022184s000lbl.pdf
2010-09-07 00:00:00
17051 2 022184 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022184s001lbl.pdf
2012-03-16 00:00:00
17052 2 022185 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s012lbl.pdf
2012-12-04 00:00:00
17053 2 022185 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s020lbl.pdf
2014-07-29 00:00:00
17054 2 022187 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf
2010-12-22 00:00:00
17055 2 022187 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s009lbl.pdf
2012-03-26 00:00:00
17056 2 022187 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s010lbl.pdf
2012-08-15 00:00:00
17057 2 022187 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
2013-03-01 00:00:00
17058 2 022187 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
2013-03-01 00:00:00
17059 2 022187 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
2013-03-01 00:00:00
17060 2 022192 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022192lbl.pdf 2009-
05-11 00:00:00
17061 2 022192 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s004lbl.pdf
2011-03-28 00:00:00
17062 2 022192 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf
2011-09-12 00:00:00
17063 2 022192 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s015lbl.pdf
2016-06-01 00:00:00
17064 2 022192 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s017lbl.pdf
2016-01-06 00:00:00
17065 2 022193 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022193lbl.pdf 2008-
07-29 00:00:00
17066 2 022195 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf
2008-03-24 00:00:00
17067 2 022195 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022195s006lbl.pdf
2012-01-23 00:00:00
17068 2 022196 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022196lbl.pdf 2009-
01-06 00:00:00
17069 2 022198 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022198lbl.pdf 2008-
09-19 00:00:00
17070 2 022200 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf
2012-01-27 00:00:00
17071 2 022200 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf
2014-03-04 00:00:00
17072 2 022200 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf
2014-05-28 00:00:00
17073 2 022200 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf
2015-03-09 00:00:00
17074 2 022200 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.
pdf 2015-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf
2015-03-27 00:00:00
17076 2 022201 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022201lbl.pdf 2008-
12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s002lbl.pdf
2013-03-08 00:00:00
17078 2 022201 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s009lbl.pdf
2015-03-03 00:00:00
17079 2 022202 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022202lbl.pdf 2009-
06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022203s003lbl.pdf
2009-11-06 00:00:00
17081 2 022203 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022203s006lbl.pdf
2011-01-25 00:00:00
17082 2 022204 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022204lbl.pdf 2009-
02-04 00:00:00
17083 2 022205 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022205s000lbl.pdf
2012-02-06 00:00:00
17084 2 022205 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022205Orig1s001lbl.pdf
2014-01-13 00:00:00
17085 2 022206 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf
2009-02-20 00:00:00
17086 2 022206 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022206s006lbl.pdf
2010-03-05 00:00:00
17087 2 022206 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022206s008lbl.pdf
2012-12-18 00:00:00
17088 2 022210 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf
2020-03-23 00:00:00
17089 2 022210 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s006ltr.pdf
2020-03-23 00:00:00
17091 2 022210 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022211lbl.pdf 2009-
09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf 2008-
06-24 00:00:00
17094 2 022212 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s003lbl.pdf
2012-06-18 00:00:00
17095 2 022212 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s012lbl.pdf
2013-05-21 00:00:00
17096 2 022212 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf
2016-08-02 00:00:00
17097 2 022217 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s007lbl.pdf
2011-02-11 00:00:00
17098 2 022219 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf
2014-03-06 00:00:00
17099 2 022220 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022220lbl.pdf 2008-
06-19 00:00:00
17100 2 022221 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022221lbl.pdf 2008-
10-09 00:00:00
17101 2 022221 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022221s002lbl.pdf
2012-12-10 00:00:00
17102 2 022221 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022221s005lbl.pdf
2014-03-13 00:00:00
17103 2 022224 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf
2011-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf
2012-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf 2015-
12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022233s005lbl.pdf
2014-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022234s000lbl.pdf
2011-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022234s03lbl.pdf
2014-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf 2008-
04-23 00:00:00
17110 2 022239 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf 2009-
07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf
2016-06-06 00:00:00
17112 2 022246 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022246s000lbl.pdf
2009-09-18 00:00:00
17113 2 022247 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf
2013-11-21 00:00:00
17114 2 022247 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247s000lbl.pdf
2013-10-25 00:00:00
17115 2 022247 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf
2013-11-21 00:00:00
17116 2 022247 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022247s002lbl.pdf
2015-10-07 00:00:00
17117 2 022249 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s005lbl.pdf
2010-03-03 00:00:00
17118 2 022249 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022249s012lbl.pdf
2012-06-27 00:00:00
17119 2 022249 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s014lbl.pdf
2013-08-29 00:00:00
17120 2 022249 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s015lbl.pdf
2013-09-17 00:00:00
17121 2 022250 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022250s000lbl.pdf
2010-01-24 00:00:00
17122 2 022250 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
2012-07-23 00:00:00
17123 2 022250 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006lbl.pdf
2013-01-23 00:00:00
17124 2 022250 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s007lbl.pdf
2013-01-11 00:00:00
17125 2 022251 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s0
36lbl.pdf 2009-07-08 00:00:00
17126 2 022251 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s
033,022251s002s009lbl.pdf 2015-01-05 00:00:00
17127 2 022251 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s
037,022251s005s006lbl.pdf 2010-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf
2015-03-25 00:00:00
17129 2 022251 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,0222
51s010lbl.pdf 2011-08-05 00:00:00
17130 2 022251 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,0222
51s012lbl.pdf 2011-12-02 00:00:00
17131 2 022251 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,0222
51s013lbl.pdf 2012-08-02 00:00:00
17132 2 022251 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,0222
51s017lbl.pdf 2015-05-21 00:00:00
17133 2 022252 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022252s000lbl.pdf
2010-05-17 00:00:00
17134 2 022252 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf
2012-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022252s003lbl.pdf
2013-08-22 00:00:00
17136 2 022253 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022253lbl.pdf 2008-
10-29 00:00:00
17137 2 022253 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf 2012-
08-28 00:00:00
17138 2 022253 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s
009,022255s003s005lbl.pdf 2013-09-27 00:00:00
17139 2 022253 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,0222
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17140 2 022253 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s
020,022255s012s013lbl.pdf 2014-09-03 00:00:00
17141 2 022253 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,0222
55s016lbl.pdf 2015-07-13 00:00:00
17142 2 022254 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022253s004,022254s001lbl.p
df 2009-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s
009,022255s003s005lbl.pdf 2013-09-27 00:00:00
17144 2 022254 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,0222
55s008lbl.pdf 2013-02-06 00:00:00
17145 2 022254 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s
020,022255s012s013lbl.pdf 2014-09-03 00:00:00
17146 2 022254 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,0222
55s014lbl.pdf 2014-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf 2012-
08-28 00:00:00
17148 2 022255 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,0222
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17149 2 022255 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s
009,022255s003s005lbl.pdf 2013-09-27 00:00:00
17150 2 022255 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,0222
55s008lbl.pdf 2013-02-06 00:00:00
17151 2 022255 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,0222
55s010lbl.pdf 2013-04-19 00:00:00
17152 2 022255 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s
020,022255s012s013lbl.pdf 2014-09-03 00:00:00
17153 2 022255 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,0222
55s014lbl.pdf 2014-08-13 00:00:00
17154 2 022255 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,0222
55s016lbl.pdf 2015-07-13 00:00:00
17155 2 022256 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256lbl.pdf 2009-
01-14 00:00:00
17156 2 022256 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s002lbl.pdf
2010-02-23 00:00:00
17157 2 022256 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s004lbl.pdf
2010-02-16 00:00:00
17158 2 022256 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022256s011lbl.pdf
2011-11-09 00:00:00
17159 2 022256 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf
2015-01-30 00:00:00
17160 2 022257 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.p
df 2009-08-30 00:00:00
17161 2 022257 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.p
df 2013-04-01 00:00:00
17162 2 022257 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.p
df 2015-04-28 00:00:00
17163 2 022260 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022260s005lbl.pdf
2013-06-05 00:00:00
17164 2 022262 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022262lbl.pdf 2008-
11-07 00:00:00
17165 2 022264 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022264lbl.pdf 2009-
10-01 00:00:00
17166 2 022264 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s010lbl.pdf
2014-05-02 00:00:00
17167 2 022264 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf
2014-12-20 00:00:00
17168 2 022264 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022264s018lbl.pdf
2015-06-11 00:00:00
17169 2 022264 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022264s019lbl.pdf
2016-03-03 00:00:00
17170 2 022266 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000lbl.pdf
2009-07-17 00:00:00
17171 2 022266 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf
2012-06-11 00:00:00
17172 2 022267 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022267s001lbl.pdf
2009-10-21 00:00:00
17173 2 022268 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022268s001lbl.pdf
2010-02-23 00:00:00
17174 2 022268 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022268s003lbl.pdf
2012-08-07 00:00:00
17175 2 022271 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf
2016-06-01 00:00:00
17176 2 022272 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf 2010-
04-06 00:00:00
17177 2 022272 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf
2011-10-12 00:00:00
17178 2 022272 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf
2014-04-16 00:00:00
17179 2 022272 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf
2014-10-30 00:00:00
17180 2 022272 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf
2015-08-13 00:00:00
17181 2 022273 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022273s001lbl.pdf
2009-07-23 00:00:00
17182 2 022275 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022275lbl.pdf 2009-
05-25 00:00:00
17183 2 022275 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf
2012-11-19 00:00:00
17184 2 022275 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s009lbl.pdf
2013-04-16 00:00:00
17185 2 022275 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf
2014-03-04 00:00:00
17186 2 022276 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf 2008-
07-29 00:00:00
17187 2 022276 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf
2016-04-08 00:00:00
17188 2 022277 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.p
df 2011-02-09 00:00:00
17189 2 022277 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s009lbl.pdf
2015-09-23 00:00:00
17190 2 022277 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022277s011lbl.pdf
2016-03-04 00:00:00
17191 2 022279 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022279Orig1s000lbl.pdf
2015-05-20 00:00:00
17192 2 022281 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022281lbl.pdf 2009-
12-04 00:00:00
17193 2 022281 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022281Orig1s005lbl.pdf
2012-03-27 00:00:00
17194 2 022281 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022281Orig1s006lbl.pdf
2014-01-15 00:00:00
17195 2 022281 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022281s008lbl.pdf
2015-07-10 00:00:00
17196 2 022285 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.pdf
2015-03-12 00:00:00
17197 2 022285 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s020lbl.pdf
2014-08-08 00:00:00
17198 2 022285 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s022lbl.pdf
2016-04-07 00:00:00
17199 2 022287 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s002lbl.pdf
2010-06-24 00:00:00
17200 2 022287 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s003lbl.pdf
2010-03-26 00:00:00
17201 2 022287 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s004lbl.pdf
2010-03-26 00:00:00
17202 2 022287 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s011lbl.pdf
2011-11-01 00:00:00
17203 2 022287 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s012lbl.pdf
2011-05-26 00:00:00
17204 2 022287 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s
001lbl.pdf 2016-07-20 00:00:00
17205 2 022288 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf 2009-
09-18 00:00:00
17206 2 022291 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf
2011-12-06 00:00:00
17207 2 022291 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf
2014-02-11 00:00:00
17208 2 022291 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf
2014-04-28 00:00:00
17209 2 022291 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf
2015-06-12 00:00:00
17210 2 022292 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf
2008-06-26 00:00:00
17211 2 022292 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.p
df 2010-05-07 00:00:00
17212 2 022292 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.p
df 2012-02-22 00:00:00
17213 2 022301 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022301lbl.pdf 2008-
11-07 00:00:00
17214 2 022304 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022304s000lbl_v2.pdf
2009-02-04 00:00:00
17215 2 022304 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf
2010-11-01 00:00:00
17216 2 022304 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012
lbl.pdf 2013-07-12 00:00:00
17217 2 022304 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012
lbl.pdf 2013-07-12 00:00:00
17218 2 022304 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf
2013-11-01 00:00:00
17219 2 022307 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022307s000lbl.pdf
2009-07-13 00:00:00
17220 2 022307 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf
2010-12-06 00:00:00
17221 2 022307 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022307s007lbl.pdf
2012-12-04 00:00:00
17222 2 022309 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf
2013-05-20 00:00:00
17223 2 022309 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf
2014-11-20 00:00:00
17224 2 022310 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022310lbl.pdf 2009-
01-06 00:00:00
17225 2 022311 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022311lbl.pdf 2009-
01-02 00:00:00
17226 2 022311 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022311s015lbl.pdf
2014-12-10 00:00:00
17227 2 022314 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022314lbl.pdf 2009-
05-11 00:00:00
17228 2 022314 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s005lbl.pdf
2011-06-27 00:00:00
17229 2 022314 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s009lbl.pdf
2012-02-17 00:00:00
17230 2 022314 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s011lbl.pdf
2011-10-31 00:00:00
17231 2 022314 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s013lbl.pdf
2012-10-01 00:00:00
17232 2 022314 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s014lbl.pdf
2012-12-10 00:00:00
17233 2 022314 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022314s020lbl.pdf
2015-07-30 00:00:00
17234 2 022315 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf 2009-
06-22 00:00:00
17235 2 022315 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf
2014-02-10 00:00:00
17236 2 022318 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.p
df 2016-03-14 00:00:00
17237 2 022321 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022321s007lbl.pdf
2012-07-12 00:00:00
17238 2 022321 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s012lbl.pdf
2013-06-03 00:00:00
17239 2 022321 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s013lbl.pdf
2013-11-05 00:00:00
17240 2 022321 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s016lbl.pdf
2014-10-17 00:00:00
17241 2 022321 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s017lbl.pdf
2014-04-16 00:00:00
17242 2 022325 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022325s001lbl.pdf
2010-11-18 00:00:00
17243 2 022327 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s017lbl.pdf
2013-11-26 00:00:00
17244 2 022327 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s018lbl.pdf
2013-11-26 00:00:00
17245 2 022327 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s019lbl.pdf
2013-11-19 00:00:00
17246 2 022328 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf
2015-09-14 00:00:00
17247 2 022331 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf
2010-10-07 00:00:00
17248 2 022331 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s005lbl.pdf
2010-10-07 00:00:00
17249 2 022331 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022331s012lbl.pdf
2013-02-14 00:00:00
17250 2 022331 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022331s014lbl.pdf
2014-12-16 00:00:00
17251 2 022332 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf 2009-
05-25 00:00:00
17252 2 022332 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf
2014-05-02 00:00:00
17253 2 022332 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf
2015-04-07 00:00:00
17254 2 022334 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf 2009-
04-03 00:00:00
17255 2 022334 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf
2010-05-17 00:00:00
17256 2 022334 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf
2010-07-12 00:00:00
17257 2 022334 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf
2010-11-01 00:00:00
17258 2 022334 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf
2011-05-06 00:00:00
17259 2 022334 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf
2012-04-02 00:00:00
17260 2 022334 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf
2012-08-31 00:00:00
17261 2 022334 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s
002s004s005lbl.pdf 2014-02-21 00:00:00
17262 2 022334 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf
2013-11-08 00:00:00
17263 2 022334 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s
002s004s005lbl.pdf 2014-02-21 00:00:00
17264 2 022334 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pd
f 2014-07-02 00:00:00
17265 2 022334 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf
2014-12-19 00:00:00
17266 2 022334 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s029lbl.pdf
2015-01-29 00:00:00
17267 2 022334 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s031lbl.pdf
2015-09-23 00:00:00
17268 2 022334 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.p
df 2016-02-02 00:00:00
17269 2 022334 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s038lbl.pdf
2016-06-17 00:00:00
17270 2 022341 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf 2010-
01-26 00:00:00
17271 2 022341 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf
2012-04-09 00:00:00
17272 2 022341 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf
2012-12-18 00:00:00
17273 2 022341 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf
2013-04-17 00:00:00
17274 2 022341 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf
2015-03-26 00:00:00
17275 2 022341 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf
2016-04-27 00:00:00
17276 2 022345 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf
2011-06-16 00:00:00
17277 2 022345 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf
2012-03-19 00:00:00
17278 2 022345 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s007lbl.pdf
2013-06-11 00:00:00
17279 2 022345 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf
2016-05-23 00:00:00
17280 2 022348 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022348s005lbl.pdf
2015-11-25 00:00:00
17281 2 022350 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf
2011-02-24 00:00:00
17282 2 022350 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004lbl.pdf
2011-12-23 00:00:00
17283 2 022350 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022350s011lbl.pdf
2013-06-04 00:00:00
17284 2 022351 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf 2009-
07-31 00:00:00
17285 2 022352 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf
2010-05-07 00:00:00
17286 2 022352 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf
2011-07-25 00:00:00
17287 2 022352 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf
2015-12-31 00:00:00
17288 2 022353 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf 2009-
10-21 00:00:00
17289 2 022360 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s006lbl.pdf
2013-09-24 00:00:00
17290 2 022360 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s007lbl.pdf
2013-11-07 00:00:00
17291 2 022362 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf 2009-
10-07 00:00:00
17292 2 022362 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022362s007lbl.pdf
2011-07-18 00:00:00
17293 2 022362 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.p
df 2012-01-06 00:00:00
17294 2 022362 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.p
df 2014-01-23 00:00:00
17295 2 022363 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s005lbl.pdf
2011-06-16 00:00:00
17296 2 022363 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s006lbl.pdf
2011-08-05 00:00:00
17297 2 022363 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf
2012-02-28 00:00:00
17298 2 022369 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022369s004lbl.pdf
2011-09-16 00:00:00
17299 2 022369 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022369s005lbl.pdf
2012-03-29 00:00:00
17300 2 022369 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf
2014-09-09 00:00:00
17301 2 022369 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf
2014-09-09 00:00:00
17302 2 022372 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf
2012-11-02 00:00:00
17303 2 022386 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf 2008-
06-26 00:00:00
17304 2 022386 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf
2012-03-06 00:00:00
17305 2 022387 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf
2016-06-13 00:00:00
17306 2 022393 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s004lbl.pdf
2011-06-16 00:00:00
17307 2 022393 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022393s011lbl.pdf
2013-06-18 00:00:00
17308 2 022393 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022393s013lbl.pdf
2014-10-16 00:00:00
17309 2 022395 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022395lbl.pdf 2009-
11-17 00:00:00
17310 2 022396 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022396s000lbledt.pdf
2015-01-08 00:00:00
17311 2 022399 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s003lbl.pdf
2012-06-11 00:00:00
17312 2 022399 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s004lbl.pdf
2012-04-20 00:00:00
17313 2 022399 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s008lbl.pdf
2013-05-09 00:00:00
17314 2 022401 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022401lbl.pdf 2009-
10-16 00:00:00
17315 2 022401 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s004lbl.pdf
2012-01-23 00:00:00
17316 2 022401 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf
2012-10-22 00:00:00
17317 2 022401 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf
2012-10-22 00:00:00
17318 2 022401 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s010lbl.pdf
2011-11-14 00:00:00
17319 2 022401 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s011lbl.pdf
2012-03-30 00:00:00
17320 2 022401 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022401s016lbl.pdf
2014-12-16 00:00:00
17321 2 022402 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf
2012-04-20 00:00:00
17322 2 022402 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf
2013-05-14 00:00:00
17323 2 022404 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022404lbl.pdf 2010-
05-03 00:00:00
17324 2 022404 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022404s003lbl.pdf
2013-03-08 00:00:00
17325 2 022405 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf
2011-04-15 00:00:00
17326 2 022405 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf
2013-07-05 00:00:00
17327 2 022405 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf
2014-04-01 00:00:00
17328 2 022406 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022406s000lbl.pdf
2011-07-07 00:00:00
17329 2 022406 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf
2012-11-06 00:00:00
17330 2 022406 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf
2012-11-06 00:00:00
17331 2 022406 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022406s004lbl.pdf
2013-03-05 00:00:00
17332 2 022406 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s007lbl.pdf
2014-01-10 00:00:00
17333 1 019221 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221s042ltr.pdf
2012-02-23 00:00:00
17334 1 019221 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221Orig1s043ltr.pdf
2012-09-17 00:00:00
17335 1 019221 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019221Orig1s045ltr.pdf
2015-08-27 00:00:00
17336 1 019257 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257
Orig1s012,020182Orig1s013ltr.pdf 2015-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019258s019ltr.pdf
2012-05-21 00:00:00
17338 1 019258 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019258Orig1s021ltr.pdf
2015-08-10 00:00:00
17339 1 019258 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019258Orig1s023ltr.pdf
2016-01-15 00:00:00
17340 1 019260 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19260slr007ltr.pdf
2003-05-29 00:00:00
17341 1 019268 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19268s037ltr.pdf
2002-04-17 00:00:00
17342 1 019268 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr039ltr.pdf
2003-08-14 00:00:00
17343 1 019268 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr040ltr.pdf
2003-08-14 00:00:00
17344 1 019268 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019268Orig1s047ltr.pdf
2012-11-21 00:00:00
17345 1 019280 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-
S008_Cyklokapron.pdf 1999-09-09 00:00:00
17346 1 019281 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019281s025ltr.pdf
2008-12-24 00:00:00
17347 1 019281 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019281s027ltr.pdf
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17348 1 019281 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019281s030ltr.pdf
2011-02-02 00:00:00
17349 1 019292 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019292Orig1s010ltr.pdf
2015-07-10 00:00:00
17350 1 019297 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr
.pdf 2003-01-13 00:00:00
17351 1 019297 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019297s030,s031ltr.pdf
2009-02-13 00:00:00
17352 1 019297 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019297s033,s034ltr.pdf
2010-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019297s035ltr.pdf
2012-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr05
9,19308slr017ltr.pdf 2003-05-29 00:00:00
17355 1 019308 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,
et al_ltr.pdf 2005-08-31 00:00:00
17356 1 019308 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037
Orig1s070,019308Orig1s027ltr.pdf 2013-09-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19221slr027,19309slr02
5ltr.pdf 2002-10-30 00:00:00
17358 1 019316 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019316s011ltr.pdf
2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019339s038ltr.pdf
2009-07-31 00:00:00
17360 1 019339 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019339s047ltr.pdf
2011-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019339Orig1s054ltr.pdf
2014-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19367slr015ltr.pdf
2003-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019367s021ltr.pdf
2005-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm05
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf
2001-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf
2001-04-23 00:00:00
17368 1 019384 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s045LTR.pdf
2006-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s046LTR.pdf
2006-09-27 00:00:00
17370 1 019384 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s049ltr.pdf
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17371 1 019384 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s053ltr.pdf
2009-02-13 00:00:00
17372 1 019384 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s054ltr.pdf
2009-05-04 00:00:00
17373 1 019384 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s056ltr.pdf
2011-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s059ltr.pdf
2011-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s060ltr.pdf
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17376 1 019384 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s061ltr.pdf
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17377 1 019384 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s063ltr.pdf
2012-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr
.pdf 2003-10-09 00:00:00
17379 1 019385 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr
.pdf 2003-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf
2003-01-27 00:00:00
17381 1 019386 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scm022ltr.pdf
2003-05-30 00:00:00
17382 1 019386 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019386s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019386Orig1s043ltr.pdf
2012-12-13 00:00:00
17384 1 019389 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr021ltr.pdf
2002-12-19 00:00:00
17385 1 019389 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr025ltr.pdf
2002-12-16 00:00:00
17386 1 019398 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm05
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17387 1 019407 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19407slr010ltr.pdf
2002-08-23 00:00:00
17388 1 019414 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019414s012ltr.pdf
2010-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19422se8-
032ltr.pdf 2003-12-23 00:00:00
17390 1 019425 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019425s021ltr.pdf
2010-11-30 00:00:00
17391 1 019429 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19429slr006ltr.pdf
2002-08-26 00:00:00
17392 1 019429 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019429s023ltr.pdf
2008-04-28 00:00:00
17393 1 019429 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019429Orig1s035ltr.pdf
2013-05-13 00:00:00
17394 1 019430 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19430slr025ltr.pdf
2003-12-22 00:00:00
17395 1 019430 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019430s044ltr.pdf
2008-10-01 00:00:00
17396 1 019430 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019430s047ltr.pdf
2009-05-26 00:00:00
17397 1 019430 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019430Orig1s053ltr.pdf
2012-08-22 00:00:00
17398 1 019430 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430Orig1s059ltr.pdf
2014-05-01 00:00:00
17399 1 019430 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019430Orig1s061ltr.pdf
2016-05-20 00:00:00
17400 1 019436 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19436slr019,20343slr01
4ltr.pdf 2003-04-18 00:00:00
17401 1 019436 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020l
tr.pdf 2007-05-07 00:00:00
17402 1 019436 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022,
020343s021ltr.pdf 2007-11-08 00:00:00
17403 1 019437 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19437slr014ltr.pdf
2003-07-06 00:00:00
17404 1 019437 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm05
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17405 1 019438 SUPPL 14 0

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2,etc,ltr.pdf 2004-05-27 00:00:00
17406 1 019445 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19445s4ltr.pdf
1998-11-23 00:00:00
17407 1 019452 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.
pdf 2005-11-18 00:00:00
17408 1 019453 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19453slr014ltr.pdf
2003-04-14 00:00:00
17409 1 019462 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf
2002-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034,
019510s031, 020249s013ltr.pdf 2007-11-08 00:00:00
17411 1 019462 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019462Orig1s038ltr.pdf
2014-02-10 00:00:00
17412 1 019463 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019463s028ltr.pdf
2011-10-03 00:00:00
17413 1 019465 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466
Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf 2016-06-14
00:00:00
17414 1 019481 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019481s007ltr.pdf
2007-05-09 00:00:00
17415 1 019481 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019481Orig1s013ltr.pdf
2015-11-04 00:00:00
17416 1 019482 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf
2002-02-04 00:00:00
17417 1 019487 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr02
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17418 1 019487 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019487Orig1s027ltr.pdf
2015-03-19 00:00:00
17419 1 019501 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19501scs024ltr.pdf
2004-06-30 00:00:00
17420 1 019507 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019507s007ltr.pdf
2009-05-14 00:00:00
17421 1 019508 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19508S30LTR.PDF
2001-03-02 00:00:00
17422 1 019510 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf
2002-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034,
019510s031, 020249s013ltr.pdf 2007-11-08 00:00:00
17424 1 019516 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516slr021ltr.pdf
2003-08-14 00:00:00
17425 1 019516 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s036ltr.pdf
2012-07-11 00:00:00
17426 1 019516 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019516Orig1s038ltr.pdf
2013-04-16 00:00:00
17427 1 019516 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s042ltr.pdf
2014-04-17 00:00:00
17428 1 019516 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019516Orig1s046ltr.pdf
2015-06-29 00:00:00
17429 1 019520 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19520S18LTR.PDF
2000-04-12 00:00:00
17430 1 019532 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr01
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17431 1 019537 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537s41ltr.pdf
2002-04-17 00:00:00
17432 1 019537 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537scp043ltr.pdf
2002-12-16 00:00:00
17433 1 019537 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20
780slr012,014,015ltr.pdf 2004-03-28 00:00:00
17434 1 019537 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19
857s035,20780s016ltr.pdf 2005-01-11 00:00:00
17435 1 019537 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s01
7,018ltr.pdf 2004-07-21 00:00:00
17436 1 019537 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s057,020780s019l
tr.pdf 2005-05-20 00:00:00
17437 1 019537 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,198
57s46,20780s24,21473s22ltr.pdf 2007-07-05 00:00:00
17439 1 019537 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s067,020780s025l
tr.pdf 2008-01-22 00:00:00
17440 1 019537 SUPPL 70 0

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tr.pdf 2009-05-07 00:00:00
17441 1 019537 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s073,020780s030l
tr.pdf 2009-04-10 00:00:00
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019857s054,020780s033,021473s028ltr.pdf 2011-03-02 00:00:00
17443 1 019537 SUPPL 78 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s078,020780s036l
tr.pdf 2011-06-14 00:00:00
17444 1 019537 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,
019857s059,020780s038,021473s033ltr.pdf 2011-10-20 00:00:00
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Orig1s039ltr.pdf 2013-01-31 00:00:00
17446 1 019537 SUPPL 86 0

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019857s065,020780s043,021473Orig1s037ltr.pdf 2016-07-26 00:00:00
17447 1 019543 SUPPL 11 0
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013ltr.pdf 2002-07-17 00:00:00
17448 1 019543 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19543slr014ltr.pdf
2004-06-03 00:00:00
17449 1 019555 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf
2001-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf
2001-10-03 00:00:00
17451 1 019555 SUPPL 26 0

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2006-09-18 00:00:00
17452 1 019555 SUPPL 33 0

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019716s030ltr.pdf 2014-08-14 00:00:00
17453 1 019557 SUPPL 28 0

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2004-05-07 00:00:00
17455 1 019558 SUPPL 44 0

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019778s037LTR.pdf 2006-06-20 00:00:00
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s052ltr.pdf 2008-10-14 00:00:00
17458 1 019558 SUPPL 54 0

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tr.pdf 2011-11-21 00:00:00
17459 1 019558 SUPPL 59 0

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2015-09-01 00:00:00
17461 1 019579 SUPPL 16 0

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lr016,018,19964slr011,014ltr.pdf 2003-03-25 00:00:00
17462 1 019579 SUPPL 25 0

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0ltr.pdf 2003-09-30 00:00:00
17463 1 019579 SUPPL 26 0

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2,19964slr021ltr.pdf 2004-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022442s000lbl.pdf
2011-06-10 00:00:00
17595 2 022450 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf
2013-10-22 00:00:00
17596 2 022453 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf
2016-02-25 00:00:00
17597 2 022456 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,0218
50s003,022456s002lbl.pdf 2010-09-10 00:00:00
17598 2 022456 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s006lbl.pdf
2012-05-29 00:00:00
17599 14 022458 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17600 2 022460 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022460s000lbl.pdf
2010-06-15 00:00:00
17601 2 022460 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022460s001lbl.pdf
2011-06-10 00:00:00
17602 2 022460 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022460s002lbl.pdf
2012-06-28 00:00:00
17603 2 022460 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf
2013-04-29 00:00:00
17604 2 022462 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf
2010-11-26 00:00:00
17605 2 022465 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf 2009-
10-20 00:00:00
17606 2 022465 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf
2011-10-25 00:00:00
17607 2 022465 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-
012lbl.pdf 2012-04-27 00:00:00
17608 2 022465 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011lbl.pdf
2012-03-23 00:00:00
17609 2 022465 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-
012lbl.pdf 2012-04-27 00:00:00
17610 2 022465 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf
2013-08-15 00:00:00
17611 2 022465 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf
2013-08-15 00:00:00
17612 2 022465 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s019lbl.pdf
2014-11-20 00:00:00
17613 2 022465 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf
2015-04-01 00:00:00
17614 2 022465 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s021lbl.pdf
2015-10-06 00:00:00
17615 2 022465 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s022lbl.pdf
2016-05-23 00:00:00
17616 2 022466 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022466lbl.pdf 2010-
03-02 00:00:00
17617 2 022468 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf 2009-
09-25 00:00:00
17618 2 022468 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
2011-01-10 00:00:00
17619 2 022468 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
2011-01-10 00:00:00
17620 2 022468 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf
2012-06-06 00:00:00
17621 2 022468 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf
2016-05-17 00:00:00
17622 14 022472 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17623 14 022472 SUPPL 3 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17624 14 022472 SUPPL 4 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17625 14 022472 SUPPL 5 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17626 14 022472 SUPPL 6 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17627 14 022472 SUPPL 8 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17628 2 022473 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.p
df 2010-11-26 00:00:00
17629 2 022473 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022473s003lbl.pdf
2012-09-06 00:00:00
17630 2 022473 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s
006,203109s003s004lbl.pdf 2014-02-03 00:00:00
17631 2 022473 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,2031
09s009lbl.pdf 2015-05-12 00:00:00
17632 2 022474 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s004lbl.pdf
2014-06-17 00:00:00
17633 2 022474 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022474s007lbl.pdf
2015-03-12 00:00:00
17634 2 022483 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf
2011-02-18 00:00:00
17635 2 022483 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.p
df 2011-03-28 00:00:00
17636 2 022483 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf
2011-07-18 00:00:00
17637 2 022483 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf
2012-02-17 00:00:00
17638 2 022485 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf 2011-
05-09 00:00:00
17639 2 022488 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf
2010-01-08 00:00:00
17640 2 022488 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s
002s003lbl.pdf 2011-04-29 00:00:00
17641 2 022488 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s
002s003lbl.pdf 2011-04-29 00:00:00
17642 2 022488 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.p
df 2013-12-24 00:00:00
17643 2 022488 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.p
df 2016-03-15 00:00:00
17644 2 022496 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf
2014-12-16 00:00:00
17645 2 022497 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022497s002lbl.pdf
2014-07-22 00:00:00
17646 2 022499 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022499lbl.pdf 2009-
12-10 00:00:00
17647 2 022500 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022500lbl.pdf 2009-
12-10 00:00:00
17648 2 022501 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf
2010-10-25 00:00:00
17649 2 022502 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022502s003lbl.pdf
2013-04-23 00:00:00
17650 2 022503 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022503s000lbl.pdf
2015-06-04 00:00:00
17651 2 022504 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s002lbl.pdf
2011-04-01 00:00:00
17652 2 022504 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s005lbl.pdf
2011-12-23 00:00:00
17653 2 022504 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf
2015-05-13 00:00:00
17654 14 022505 SUPPL 3 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17655 2 022510 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s000lbl.pdf
2011-01-10 00:00:00
17656 2 022510 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf
2012-01-06 00:00:00
17657 2 022510 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf
2012-06-11 00:00:00
17658 2 022510 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf
2014-11-07 00:00:00
17659 2 022511 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf
2011-06-29 00:00:00
17660 2 022511 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007lbl.pdf
2012-10-04 00:00:00
17661 2 022511 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008lbl.pdf
2012-10-12 00:00:00
17662 2 022511 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s012lbl.pdf
2014-02-27 00:00:00
17663 2 022511 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s018lbl.pdf
2016-05-11 00:00:00
17664 2 022512 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022512s000lbl.pdf
2010-10-20 00:00:00
17665 2 022512 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s010lbl.pdf
2012-05-01 00:00:00
17666 2 022512 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s011lbl.pdf
2012-06-11 00:00:00
17667 2 022512 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512Orig1s031lbl.pdf
2015-09-21 00:00:00
17668 2 022516 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516lbl.pdf 2010-
11-05 00:00:00
17669 2 022518 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s005lbl.pdf
2012-08-22 00:00:00
17670 2 022518 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s006lbl.pdf
2012-11-28 00:00:00
17671 2 022518 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf
2013-08-09 00:00:00
17672 2 022518 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s013lbl.pdf
2013-08-22 00:00:00
17673 2 022518 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.p
df 2016-07-13 00:00:00
17674 2 022519 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000lbl.pdf
2011-04-26 00:00:00
17675 2 022522 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022522s006lbl.pdf
2015-11-25 00:00:00
17676 14 022523 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17677 14 022523 SUPPL 4 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17678 14 022523 SUPPL 5 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17679 2 022524 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf
2013-10-31 00:00:00
17680 2 022525 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022525s000lbl.pdf
2010-06-02 00:00:00
17681 2 022527 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022527s000lbl.pdf
2010-09-23 00:00:00
17682 2 022527 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022527s009lbl.pdf
2014-05-02 00:00:00
17683 2 022527 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s016lbl.pdf
2015-07-06 00:00:00
17684 2 022527 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf
2016-02-23 00:00:00
17685 2 022527 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s019lbl.pdf
2015-08-06 00:00:00
17686 2 022532 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf
2012-02-14 00:00:00
17687 2 022532 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf
2012-04-10 00:00:00
17688 2 022532 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf
2015-06-04 00:00:00
17689 2 022534 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf
2011-05-24 00:00:00
17690 2 022535 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf
2014-10-16 00:00:00
17691 2 022536 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022536lbl.pdf 2010-
03-18 00:00:00
17692 2 022544 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf
2012-02-01 00:00:00
17693 2 022544 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf
2013-04-01 00:00:00
17694 2 022545 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf
2010-08-27 00:00:00
17695 2 022545 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s005lbl.pdf
2011-10-20 00:00:00
17696 2 022545 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s008lbl.pdf
2011-11-14 00:00:00
17697 2 022545 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s012lbl.pdf
2012-04-16 00:00:00
17698 2 022545 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf
2012-10-01 00:00:00
17699 2 022545 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022545s014lbl.pdf
2013-11-04 00:00:00
17700 2 022545 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022545s015lbl.pdf
2014-03-19 00:00:00
17701 2 022545 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf
2015-12-28 00:00:00
17702 2 022555 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf
2010-06-03 00:00:00
17703 2 022555 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022555s004lbl.pdf
2016-08-02 00:00:00
17704 2 022556 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022556s000lbl.pdf
2013-04-01 00:00:00
17705 2 022560 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022560s000lbl.pdf
2010-10-18 00:00:00
17706 2 022560 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf
2012-03-22 00:00:00
17707 2 022560 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf
2012-03-22 00:00:00
17708 2 022560 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022560s005lbl.pdf
2013-04-23 00:00:00
17709 2 022560 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf
2015-04-10 00:00:00
17710 2 022563 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf
2011-04-22 00:00:00
17711 2 022563 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf
2012-09-28 00:00:00
17712 2 022565 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf
2015-04-14 00:00:00
17713 2 022567 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s001lbl.pdf
2011-09-23 00:00:00
17714 2 022567 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022567s005lbl.pdf
2013-01-11 00:00:00
17715 2 022567 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022567s009lbl.pdf
2013-12-19 00:00:00
17716 2 022567 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s011lbl.pdf
2014-04-08 00:00:00
17717 2 022567 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022567s012lbl.pdf
2015-03-19 00:00:00
17718 2 022567 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s013lbl.pdf
2014-07-17 00:00:00
17719 2 022568 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,0225
68s006lbl.pdf 2012-09-26 00:00:00
17720 2 022569 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s000lbl.pdf
2011-07-06 00:00:00
17721 2 022569 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017l
bl.pdf 2013-11-19 00:00:00
17722 2 022569 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017l
bl.pdf 2013-11-19 00:00:00
17723 2 022569 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017l
bl.pdf 2013-11-19 00:00:00
17724 2 022571 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf
2010-07-31 00:00:00
17725 2 022571 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022571s004lbl.pdf
2015-11-12 00:00:00
17726 2 022572 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022572s000lbl.pdf
2012-02-09 00:00:00
17727 2 022573 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022573s000lbl.pdf
2010-12-26 00:00:00
17728 2 022574 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s001lbl.pdf
2012-02-14 00:00:00
17729 2 022574 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s004lbl.pdf
2012-04-10 00:00:00
17730 2 022574 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022574s006lbl.pdf
2015-06-04 00:00:00
17731 14 022575 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17732 14 022575 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17733 14 022575 SUPPL 12 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17734 14 022575 SUPPL 13 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
17735 2 022577 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022577lbl.pdf 2012-
01-31 00:00:00
17736 2 022577 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.p
df 2012-08-08 00:00:00
17737 2 022577 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.p
df 2012-08-17 00:00:00
17738 2 022577 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.p
df 2013-07-30 00:00:00
17739 2 022577 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.p
df 2013-10-25 00:00:00
17740 2 022577 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.p
df 2016-02-18 00:00:00
17741 2 022580 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s001lbl.pdf
2012-11-02 00:00:00
17742 2 022580 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf
2013-04-17 00:00:00
17743 2 022580 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf
2014-09-30 00:00:00
17744 2 022580 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf
2014-09-30 00:00:00
17745 2 022581 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022581s000lbl.pdf
2011-04-21 00:00:00
17746 2 040024 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf
2009-09-22 00:00:00
17747 2 040056 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf
2012-08-30 00:00:00
17748 2 040098 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40098_Acetaminophen
%20And%20Codeine%20Phosphate_Prntlbl.pdf 2003-12-23 00:00:00
17749 2 040136 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040136s005lbl.pdf
2014-02-28 00:00:00
17750 2 040148 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040148s053lbl.pdf
2015-11-04 00:00:00
17751 2 040168 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40168_Hydrocortisone
%20and%20Acetic%20Acid%20Otic_Prntlbl.pdf 2003-08-01 00:00:00
17752 2 040183 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40183_Methylprednisolone_Prnt
lbl.pdf 2004-06-09 00:00:00
17753 2 040191 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40191_Meperidine
%20Hydrochloride_Prntlbl.pdf 2004-06-09 00:00:00
17754 2 040226 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40226_Perphenazaine_Prntlbl.p
df 2004-06-14 00:00:00
17755 2 040254 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40254_Trihexyphenidyl
%20Hydrochloride_Prntlbl.pdf 2004-06-28 00:00:00
17756 2 040257 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40257_Oxycodone%20and
%20Acetaminophen_Prntlbl.pdf 2004-06-10 00:00:00
17757 2 040261 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40261_Butalbital,
%20Acetaminophen%20and%20Caffeine.pdf 1998-10-28 00:00:00
17758 2 040262 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40262_Leucovorin
%20Calcium_Prntlbl.pdf 2004-06-08 00:00:00
17759 2 040263 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40263_Methotrexate_Prntlbl.pd
f 2004-06-09 00:00:00
17760 2 040266 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40266_Methotrexate_Prntlbl.pd
f 2004-06-09 00:00:00
17761 2 040274 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-
274_Hydroxychloroquine%20Sulfate_Prntlbl.pdf 2004-06-07 00:00:00
17762 2 040277 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40277_Proparacaine
%20Hydrochloride%20Ophthalmic_Prntlbl.pdf 2004-06-14 00:00:00
17763 2 040279 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Prntlbl.pd
f 2004-06-04 00:00:00
17764 2 040298 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/40298lbl.pdf 1998-
12-28 00:00:00
17765 2 040300 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-300_Methylphenidate
%20Hydrochloride_Prntlbl.pdf 2004-06-09 00:00:00
17766 2 040303 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40303_Oxycodone%20and
%20Acetaminophen_Prntlbl.pdf 2004-06-10 00:00:00
17767 2 040306 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40306_Metadate_Prntlbl.pdf
2003-12-23 00:00:00
17768 2 040310 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40310_Hydrocortisone_Prntlb
l.pdf 2004-06-07 00:00:00
17769 2 040320 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040320s005lbl.pdf
2012-07-25 00:00:00
17770 2 040323 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/40323lbl.pdf 1999-
05-13 00:00:00
17771 2 040333 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40333_Fluorouracil_Prntlbl.
pdf 2003-12-23 00:00:00
17772 2 040334 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Prntlbl.
pdf 2004-06-04 00:00:00
17773 2 040341 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,0404
34s003lbl.pdf 2006-11-30 00:00:00
17774 2 040350 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040350s016lbl.pdf
2015-08-14 00:00:00
17775 2 040352 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40352_Meperidine
%20Hydrochloride_Prntlbl.pdf 2004-06-09 00:00:00
17776 2 040361 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-
361_Dextroamphetamine%20Sulfate_Prntlbl.pdf 2004-06-02 00:00:00
17777 2 040374 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40374_Triamcinolone
%20Acetonide_Prntlbl.pdf 2003-12-23 00:00:00
17778 2 040378 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40378_Niacor_Prntlbl.pdf
2004-06-10 00:00:00
17779 2 040391 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040391Orig1s007lbl.pdf
2014-06-24 00:00:00
17780 2 040422 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040422Orig1s030lbl.pdf
2014-01-09 00:00:00
17781 2 040422 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040422s036lbl.pdf
2014-06-20 00:00:00
17782 2 040432 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658
s006, 40846s005, 89699s044lbl.pdf 2015-10-27 00:00:00
17785 2 040572 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/40572s002lbledt.pdf
2015-08-17 00:00:00
17786 2 040745 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf
2014-10-27 00:00:00
17787 2 040770 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/040735s004,040770s003lbl.p
df 2011-08-26 00:00:00
17788 2 050006 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480
s42,050533s36lbl.pdf 2008-02-14 00:00:00
17789 2 050006 SUPPL 84 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,0504
80s050,050533s040lbl.pdf 2013-05-01 00:00:00
17790 2 050006 SUPPL 85 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,05048
0s051,050533s041lbl.pdf 2013-09-09 00:00:00
17791 2 050007 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480
s42,050533s36lbl.pdf 2008-02-14 00:00:00
17792 2 050007 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,0504
80s047,050533s038lbl.pdf 2011-05-16 00:00:00
17793 2 050007 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,0504
80s050,050533s040lbl.pdf 2013-05-01 00:00:00
17794 2 050007 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,05048
0s051,050533s041lbl.pdf 2013-09-09 00:00:00
17795 2 050065 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitro
l_lbl.pdf 2003-07-28 00:00:00
17796 2 050065 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf
2004-07-21 00:00:00
17797 2 050091 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50091s40lbl.pdf
2003-05-02 00:00:00
17798 2 050095 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf
2008-07-29 00:00:00
17799 2 050108 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050108s026lbl.pdf
2009-06-07 00:00:00
17800 2 050108 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050108s030lbl.pdf
2013-03-08 00:00:00
17801 2 050138 SUPPL 231 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050138s231lbl.pdf
2009-12-22 00:00:00
17802 2 050138 SUPPL 234 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050138s234lbl.pdf
2012-09-11 00:00:00
17803 2 050141 SUPPL 233 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050141s233lbl.pdf
2015-10-15 00:00:00
17804 2 050162 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s
013lbl.pdf 2004-10-04 00:00:00
17805 2 050162 SUPPL 85 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050162s085lbl.pdf
2009-11-23 00:00:00
17806 2 050162 SUPPL 95 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf
2016-03-29 00:00:00
17807 2 050162 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf
2016-03-29 00:00:00
17808 2 050168 SUPPL 78 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50168slr078_cotisporin_lbl
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17809 2 050207 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.p
df 2006-08-11 00:00:00
17810 2 050207 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050207s064lbl.pdf
2011-01-31 00:00:00
17811 2 050207 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.p
df 2009-01-02 00:00:00
17812 2 050207 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050207s071lbl.pdf
2012-02-06 00:00:00
17813 2 050261 SUPPL 100 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050261s100lbl.pdf
2008-06-05 00:00:00
17814 2 050261 SUPPL 101 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050261s101lbl.pdf
2012-09-06 00:00:00
17815 2 050278 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf
2015-05-12 00:00:00
17816 2 050297 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.p
df 2006-08-11 00:00:00
17817 2 050297 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.p
df 2009-01-02 00:00:00
17818 2 050317 SUPPL 177 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050317s177lbl.pdf
2014-10-16 00:00:00
17819 2 050356 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050356s050lbl.pdf
2009-06-04 00:00:00
17820 2 050405 SUPPL 97 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf
2006-05-16 00:00:00
17821 2 050420 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.p
df 2010-11-12 00:00:00
17822 2 050429 SUPPL 83 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50429s083lbl.pdf
2004-12-03 00:00:00
17823 2 050435 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050435s009lbl.pdf
2008-02-28 00:00:00
17824 2 050441 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.p
df 2008-02-25 00:00:00
17825 2 050441 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066,
s067, s068lbl.pdf 2014-06-25 00:00:00
17826 2 050441 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066,
s067, s068lbl.pdf 2014-06-25 00:00:00
17827 2 050441 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf
2016-03-29 00:00:00
17828 2 050442 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050442s016lbl.pdf
2013-09-17 00:00:00
17829 2 050442 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,0504
42s018,050480s054,050533s043lbledt.pdf 2016-04-07 00:00:00
17830 2 050443 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50443slr035_blenoxane_lbl.
pdf 2003-03-26 00:00:00
17831 2 050443 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050443s036lbl.pdf
2010-05-11 00:00:00
17832 2 050444 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.p
df 2007-01-18 00:00:00
17833 2 050444 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050444s048lbl.pdf
2014-11-18 00:00:00
17834 2 050444 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050444s049lbl.pdf
2015-04-22 00:00:00
17835 2 050445 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf
2005-09-30 00:00:00
17836 2 050445 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050445s028lbl.pdf
2010-09-20 00:00:00
17837 2 050461 SUPPL 135 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr135_ancef_lbl.pdf
2004-01-22 00:00:00
17838 2 050467 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl
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17839 2 050467 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-
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17840 2 050467 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050467s073lbl.pdf
2013-11-01 00:00:00
17841 2 050475 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-
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17842 2 050475 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf
2010-10-19 00:00:00
17843 2 050475 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf
2016-04-20 00:00:00
17844 2 050480 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,0504
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17845 2 050480 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,05048
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17846 2 050480 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,0504
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17847 2 050512 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,0505
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17849 2 050514 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050514s009lbl.pdf
2008-07-22 00:00:00
17850 2 050517 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50517slr046_mefoxin_lbl.pd
f 2004-06-07 00:00:00
17851 2 050517 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050517s051lbl.pdf
2013-05-14 00:00:00
17852 2 050526 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50526slr010_Staticin_lbl.p
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17853 2 050527 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50
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17854 2 050533 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,0504
80s050,050533s040lbl.pdf 2013-05-01 00:00:00
17855 2 050533 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,05048
0s051,050533s041lbl.pdf 2013-09-09 00:00:00
17856 2 050536 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050536s020lbl.pdf
2008-02-25 00:00:00
17857 2 050537 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf
2002-07-14 00:00:00
17858 2 050537 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50
615slr005_cleocin_lbl.pdf 2003-06-08 00:00:00
17859 2 050537 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,0506
15s012lbl.pdf 2014-04-08 00:00:00
17860 2 050537 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,0506
15s014lbl.pdf 2016-01-26 00:00:00
17861 2 050541 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050541s024lbl.pdf
2013-01-02 00:00:00
17862 2 050542 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760
s10,050761s10lbl.pdf 2008-06-12 00:00:00
17863 2 050542 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s
013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 2011-11-21 00:00:00
17864 2 050542 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s
013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 2011-11-21 00:00:00
17865 2 050542 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,0507
60s020,050761s017lbl.pdf 2015-12-08 00:00:00
17866 2 050547 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.p
df 2008-02-25 00:00:00
17867 2 050547 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.p
df 2011-09-16 00:00:00
17868 2 050547 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.p
df 2014-02-25 00:00:00
17869 2 050551 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50551slr042_Cefobid_lbl.pd
f 2003-04-09 00:00:00
17870 2 050555 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tob
rex_lbl.pdf 2003-03-26 00:00:00
17871 2 050557 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050557s025lbl.pdf
2003-03-06 00:00:00
17872 2 050558 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zi
nacef_lbl.pdf 2004-05-27 00:00:00
17873 2 050558 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.p
df 2014-09-30 00:00:00
17874 2 050564 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.p
df 2008-06-12 00:00:00
17875 2 050564 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.p
df 2011-09-30 00:00:00
17876 2 050564 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s
042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 2013-01-23
00:00:00
17878 2 050573 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf
2003-03-05 00:00:00
17879 2 050573 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,03
7,50625s039,040_sandimmune_lbl.pdf 2004-03-03 00:00:00
17880 2 050573 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,0506
25s043lbl.pdf 2005-07-26 00:00:00
17881 2 050573 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,0506
25s044lbl.pdf 2006-03-10 00:00:00
17882 2 050573 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,0506
25s047lbl.pdf 2009-10-14 00:00:00
17883 2 050573 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,0505
74s042lbl.pdf 2010-05-07 00:00:00
17884 2 050573 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,0506
25s049lbl.pdf 2012-08-31 00:00:00
17885 2 050573 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,0506
25s055lbl.pdf 2015-04-01 00:00:00
17886 2 050574 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,0506
25s043lbl.pdf 2005-07-26 00:00:00
17887 2 050574 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,0506
25s055lbl.pdf 2015-04-01 00:00:00
17888 2 050575 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725
s025050726s019lbl.pdf 2008-12-08 00:00:00
17889 2 050575 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726
s20,050725s26lbl.pdf 2008-03-27 00:00:00
17890 2 050575 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,0507
25s027,050726s021lbl.pdf 2011-09-30 00:00:00
17891 2 050575 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s
042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 2013-01-23
00:00:00
17892 2 050578 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf
2002-03-29 00:00:00
17893 2 050578 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.p
df 2007-07-10 00:00:00
17894 2 050578 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbled
t.pdf 2014-09-26 00:00:00
17895 2 050580 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.p
df 2008-01-24 00:00:00
17896 2 050585 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585slr054_rocephin_lbl.p
df 2004-04-05 00:00:00
17897 2 050585 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s058lbl.pdf
2007-07-24 00:00:00
17898 2 050585 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf
2008-08-26 00:00:00
17899 2 050585 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050585s061lbl.pdf
2009-04-03 00:00:00
17900 2 050585 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s062lbl.pdf
2010-11-17 00:00:00
17901 2 050585 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s064lbl.pdf
2010-03-03 00:00:00
17902 2 050585 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050585s065lbl.pdf
2013-04-16 00:00:00
17903 2 050585 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050585s066lbl.pdf
2015-03-23 00:00:00
17904 2 050586 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf
2006-01-05 00:00:00
17905 2 050587 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050587s076lbl.pdf
2014-12-17 00:00:00
17906 2 050588 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pd
f 2004-05-28 00:00:00
17907 2 050588 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pd
f 2003-07-08 00:00:00
17908 2 050590 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,0505
90s059lbl.pdf 2010-12-26 00:00:00
17909 2 050590 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf
2011-06-14 00:00:00
17910 2 050590 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf
2011-06-14 00:00:00
17911 2 050590 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.p
df 2013-10-01 00:00:00
17912 2 050590 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.p
df 2014-06-17 00:00:00
17913 2 050592 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50592slr032_tobradex_lbl.p
df 2003-07-08 00:00:00
17914 2 050596 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.p
df 2014-02-25 00:00:00
17915 2 050596 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.p
df 2015-04-14 00:00:00
17916 2 050597 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725
s025050726s019lbl.pdf 2008-12-08 00:00:00
17917 2 050600 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf
2002-07-14 00:00:00
17918 2 050605 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf
2002-03-29 00:00:00
17919 2 050605 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf
2002-04-11 00:00:00
17920 2 050605 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ce
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17921 2 050605 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf
2007-07-24 00:00:00
17922 2 050605 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.p
df 2015-08-27 00:00:00
17923 2 050608 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050608s029lbl.pdf
2008-04-23 00:00:00
17924 2 050608 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf
2014-11-20 00:00:00
17925 2 050608 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf
2014-11-20 00:00:00
17926 2 050609 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050609s025lbl.pdf
2008-02-28 00:00:00
17927 2 050609 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050609s032lbl.pdf
2011-06-16 00:00:00
17928 2 050609 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050609s034lbl.pdf
2013-08-21 00:00:00
17929 2 050611 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s032lbl.pdf
2009-01-02 00:00:00
17930 2 050611 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050611s035lbl.pdf
2012-02-06 00:00:00
17931 2 050615 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50
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17932 2 050615 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,0506
15s012lbl.pdf 2014-04-08 00:00:00
17933 2 050616 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tob
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17934 2 050616 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf
2004-07-21 00:00:00
17935 2 050621 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_su
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17936 2 050621 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_su
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17937 2 050622 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_su
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17938 2 050622 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_su
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17939 2 050624 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s057,50624s027lbl.pdf
2004-09-15 00:00:00
17940 2 050625 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf
2003-03-05 00:00:00
17941 2 050625 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,03
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17942 2 050625 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,0506
25s043lbl.pdf 2005-07-26 00:00:00
17943 2 050625 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,0506
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17944 2 050625 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,0506
25s047lbl.pdf 2009-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,0505
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17946 2 050625 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,0506
25s049lbl.pdf 2012-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,0506
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17948 2 050627 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.p
df 2013-03-01 00:00:00
17949 2 050629 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl
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17950 2 050629 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050467s068lbl.pdf
2003-05-13 00:00:00
17951 2 050629 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050629s017lbl.pdf
2010-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050629s019lbl.pdf
2011-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050629s022lbl.pdf
2013-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050630s027lbl.pdf
2007-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050632s015lbl.pdf
2013-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf
2002-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050638s016lbl.pdf
2012-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050638s019lbl.pdf
2016-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.p
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17961 2 050639 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.p
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17962 2 050639 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
2014-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
2014-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050640s010lbl.pdf
2008-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050640s011lbl.pdf
2011-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050640s015lbl.pdf
2012-11-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050641s014lbl.pdf
2008-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050641s026lbl.pdf
2011-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050641s027lbl.pdf
2013-10-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf
2003-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf
2002-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050649s019lbl.pdf
2007-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050649023lbl.pdf
2010-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050655s023lbl.pdf
2015-04-07 00:00:00
17975 2 050658 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.p
df 2007-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050658s022lbl.pdf
2008-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,0505
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050658s024lbl.pdf
2011-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.p
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17980 2 050658 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.p
df 2013-10-01 00:00:00
17981 2 050658 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.p
df 2014-06-17 00:00:00
17982 2 050661 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050661s014lbl.pdf
2014-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50662S29lbl.pdf
2000-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,0507
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17985 2 050662 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,0507
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17986 2 050662 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s0
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,0507
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s052lbl.pdf
2013-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s053lbl.pdf
2013-09-09 00:00:00
17991 2 050662 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf
2015-01-12 00:00:00
17992 2 050662 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,0507
75s025lbl.pdf 2015-10-29 00:00:00
17993 2 050664 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_ce
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17994 2 050665 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.p
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17995 2 050670 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50
730slr011_zithromax_lbl.pdf 2004-04-05 00:00:00
17996 2 050670 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,0507
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17997 2 050671 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50671slr006_vancocin_lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050671s018lbl.pdf
2012-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050671s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf
2002-03-29 00:00:00
18001 2 050672 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf
2002-04-11 00:00:00
18002 2 050672 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.p
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18004 2 050675 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.p
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18005 2 050679 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.p
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18006 2 050679 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf
2012-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50680slr004_cleocin_lbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf
2009-04-03 00:00:00
18010 2 050682 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf
2012-02-06 00:00:00
18011 2 050684 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050684s046lbl.pdf
2006-07-27 00:00:00
18013 2 050684 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf
2008-06-05 00:00:00
18014 2 050684 SUPPL 55 0

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18015 2 050684 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s
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18017 2 050684 SUPPL 74 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s
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18018 2 050684 SUPPL 83 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.p
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2000-02-10 00:00:00
18021 2 050687 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
2000-02-10 00:00:00
18022 2 050687 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
2000-02-10 00:00:00
18023 2 050687 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
2000-02-10 00:00:00
18025 2 050688 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
2000-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
2000-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050693s014,050730s021lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s023lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050706s028lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scp004_protopic_lbl.p
df 2003-05-29 00:00:00
18228 2 050778 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050778s019lbl.pdf
2013-02-21 00:00:00
18229 2 050778 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf
2014-12-16 00:00:00
18230 2 050779 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50779lbl.pdf 2000-
08-04 00:00:00
18231 2 050779 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s018lb.pdf
2012-01-26 00:00:00
18232 2 050780 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf
2001-02-21 00:00:00
18233 2 050780 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf
2007-09-11 00:00:00
18234 2 050781 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50781lbl.pdf 2003-
05-02 00:00:00
18235 2 050783 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50783LBL.pdf 2001-
02-02 00:00:00
18236 2 050784 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,0507
84s012lbl.pdf 2009-04-03 00:00:00
18237 2 050784 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,0507
84s017lbl.pdf 2010-08-19 00:00:00
18238 2 050784 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,0507
84s018,.pdf 2011-02-04 00:00:00
18239 2 050784 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,0507
11s032,050730s029,050784s019lbl.pdf 2012-11-06 00:00:00
18240 2 050784 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,0507
84s021lbl.pdf 2014-06-10 00:00:00
18241 2 050784 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,0507
11s035,050730s030,050733s034,050784s022lbl.pdf 2012-06-11 00:00:00
18242 2 050785 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50785lbl.pdf 2002-
09-25 00:00:00
18243 2 050785 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050785s006lbl.pdf
2005-06-21 00:00:00
18244 2 050785 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf
2009-01-02 00:00:00
18245 2 050785 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf
2010-09-10 00:00:00
18246 2 050785 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050785s014lbl.pdf
2013-12-03 00:00:00
18247 2 050785 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050785s015lbl.pdf
2014-04-08 00:00:00
18248 2 050786 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf
2007-05-29 00:00:00
18249 2 050788 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50788_Mupirocin_lbl.pdf
2002-12-04 00:00:00
18250 2 050788 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050788Orig1s005lbl.pdf
2015-06-22 00:00:00
18251 2 050790 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050790lbl.pdf 2003-
09-08 00:00:00
18252 2 050790 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50790slr001_restasis_lbl.p
df 2003-09-26 00:00:00
18253 2 050790 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050790s021lbl.pdf
2013-06-04 00:00:00
18254 2 050791 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s002lbl.pdf
2008-05-16 00:00:00
18255 2 050791 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s004lbl.pdf
2009-01-02 00:00:00
18256 2 050791 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s007lbl.pdf
2009-07-14 00:00:00
18257 2 050791 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s008lbl.pdf
2009-10-14 00:00:00
18258 2 050791 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050791s011lbl.pdf
2010-10-28 00:00:00
18259 2 050791 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050791s014lbl.pdf
2012-06-26 00:00:00
18260 2 050791 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s018lbl.pdf
2013-09-30 00:00:00
18261 2 050791 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s019lbl.pdf
2013-09-30 00:00:00
18262 2 050792 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50792lbl.pdf 2004-
08-02 00:00:00
18263 2 050792 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050792s002lbl.pdf
2007-09-11 00:00:00
18264 2 050793 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf 2004-
12-03 00:00:00
18265 2 050794 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050794lbl.pdf 2004-
05-19 00:00:00
18266 2 050794 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf
2011-08-24 00:00:00
18267 2 050794 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050794s026lbledt.pdf
2014-01-13 00:00:00
18268 2 050795 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050795s003lbl.pdf
2007-12-27 00:00:00
18269 2 050795 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050795s005lbl.pdf
2008-06-26 00:00:00
18270 2 050795 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050795s010lbl.pdf
2013-04-16 00:00:00
18271 2 050795 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s013lbl.pdf
2011-03-28 00:00:00
18272 2 050795 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s014lbl.pdf
2011-09-16 00:00:00
18273 2 050795 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050795Orig1s019lbl.pdf
2016-04-01 00:00:00
18274 2 050795 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795Orig1s020lbl.pdf
2015-03-12 00:00:00
18275 2 050796 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050796lbl.pdf 2005-
04-28 00:00:00
18276 2 050796 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s017lbl.pdf
2013-04-16 00:00:00
18277 2 050796 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050796Orig1s019lbl.pdf
2015-07-10 00:00:00
18278 2 050797 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050797lbl.pdf 2005-
06-14 00:00:00
18279 2 050797 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050797s008lbl.pdf
2008-10-09 00:00:00
18280 2 050797 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf
2011-09-20 00:00:00
18281 2 050797 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf
2011-09-20 00:00:00
18282 2 050797 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050797s016lbl.pdf
2012-03-06 00:00:00
18283 2 050797 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf
2013-02-21 00:00:00
18284 2 050801 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf
2010-12-20 00:00:00
18285 2 050802 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050802lbl.pdf 2006-
11-09 00:00:00
18286 2 050804 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050804lbl.pdf 2004-
12-30 00:00:00
18287 2 050804 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050804s017lbl.pdf
2012-10-04 00:00:00
18288 2 050804 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050804s018lbl.pdf
2013-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050807lbl.pdf 2006-
09-18 00:00:00
18290 2 050808 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf
2009-07-30 00:00:00
18291 2 050808 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf
2010-01-12 00:00:00
18292 2 050808 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf
2011-03-18 00:00:00
18293 2 050810 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s012lbl.pdf
2012-10-17 00:00:00
18294 2 050813 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050813s003lbl.pdf
2019-06-05 00:00:00
18295 2 050817 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf
2010-07-06 00:00:00
18296 2 050817 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf
2012-09-11 00:00:00
18297 2 050818 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050818s001lbl.pdf
2010-08-10 00:00:00
18298 2 050819 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf
2010-07-01 00:00:00
18299 2 050819 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf
2010-10-18 00:00:00
18300 2 050821 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050821s000lbl.pdf
2010-05-17 00:00:00
18301 2 050824 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050824s000lbl.pdf
2011-02-09 00:00:00
18302 2 060359 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/060359s028lbl.pdf
2014-01-31 00:00:00
18303 2 060704 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/060704s035lbl.pdf
2014-01-31 00:00:00
18304 2 060716 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716s018lbl.pdf
2012-07-30 00:00:00
18305 2 060716 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716Orig1s020Lbl.pdf
2015-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061904Orig1s021lbl.pdf
2014-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf
2014-04-10 00:00:00
18308 2 062475 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062475s038lbl.pdf
2014-01-31 00:00:00
18309 2 062638 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/062638s029lbl.pdf
2014-01-31 00:00:00
18310 2 062644 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/062644s015lbl.pdf
2012-11-27 00:00:00
18311 2 062774 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062774s016lbl.pdf
2012-07-30 00:00:00
18312 2 062912 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062912s040lbl.pdf
2012-07-30 00:00:00
18313 2 062921 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf
2012-12-12 00:00:00
18314 2 062933 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062933s021lbl.pdf
2012-07-30 00:00:00
18315 2 062933 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062933s032lbl.pdf
2014-02-03 00:00:00
18316 2 063009 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/063009s034lbl.pdf
2014-02-21 00:00:00
18317 2 063065 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline
%20Hydrochloride_Prntlbl.pdf 2004-06-09 00:00:00
18318 2 063111 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063111s014lbl.pdf
2014-02-06 00:00:00
18319 2 064071 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf
2014-02-06 00:00:00
18320 2 064142 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64142ap_appltr_prntlbl_chemr.
pdf 1998-06-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-
217_Rifampin_prntlbl.pdf 1999-10-29 00:00:00
18322 2 065010 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065010s002lbl.pdf
2012-07-30 00:00:00
18323 2 065013 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065013s007lbl.pdf
2012-07-30 00:00:00
18324 2 065055 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065055s012lbl.pdf
2014-02-06 00:00:00
18325 2 065055 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065055Orig1s013lbl.pdf
2014-07-30 00:00:00
18326 2 065056 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065056s017lbl.pdf
2014-02-06 00:00:00
18327 2 065059 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/65-
059_Amoxicillin_prntlbl.pdf 2000-11-24 00:00:00
18328 2 065068 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065068s013lbl.pdf
2014-02-06 00:00:00
18329 2 065119 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf
2014-02-06 00:00:00
18330 2 065131 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065131s017lbl.pdf
2014-03-04 00:00:00
18331 2 065162 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf
2010-10-26 00:00:00
18332 2 065168 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065168s019lbl.pdf
2014-02-04 00:00:00
18333 2 065214 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s002lbl.pdf
2010-02-16 00:00:00
18334 2 065214 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s008lbl.pdf
2010-03-03 00:00:00
18335 2 065214 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065214s013lbl.pdf
2013-06-11 00:00:00
18336 2 065382 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/065382s000lbl.pdf
2007-09-06 00:00:00
18337 2 065446 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065446s000lbl.pdf
2009-10-21 00:00:00
18338 2 065461 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf
2009-08-13 00:00:00
18339 2 065462 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf
2014-02-20 00:00:00
18340 2 070434 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/070434s032lbl.pdf
2013-09-06 00:00:00
18341 2 070791 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/070791s027lbl.pdf
2014-09-05 00:00:00
18342 2 071165 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071165s020lbl.pdf
2010-02-22 00:00:00
18343 2 071259 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/071259s027lbl.pdf
2012-07-30 00:00:00
18344 2 071297 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026lbl.pdf
2014-07-30 00:00:00
18345 2 071297 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071297s030lbl.pdf
2014-09-05 00:00:00
18346 2 071413 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071413s019lbl.pdf
2011-10-06 00:00:00
18347 2 071443 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071443s028lbl.pdf
2014-09-05 00:00:00
18348 2 071609 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071609s028lbl.pdf
2014-09-05 00:00:00
18349 2 072285 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072285s021lbl.pdf
2014-09-05 00:00:00
18350 2 072691 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072691s036lbl.pdf
2014-09-05 00:00:00
18351 2 073193 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073193SOrig1s33Lbl.pdf
2015-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf
2013-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/074286Orig1s017lbl.pdf
2015-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin
%20Hydrochloride_prntlbl.pdf 2004-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74446_Terazosin
%20Hydrochloride_Prntlbl.pdf 2004-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74489_Hydrocortisone
%20Valertate_prntlbl.pdf 2004-06-07 00:00:00
18357 2 074496 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74496_Lorazepam_Prntlbl.pdf
2004-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-
507_Nicotine_prntlbl.pdf 2004-06-10 00:00:00
18359 2 074538 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/074538s017lbl.pdf
2014-01-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074650s010lbl.pdf
2014-02-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74657_Terazosin
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74726_KLOR-
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/74752lbl.pdf 1998-
07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/074802s038lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pd
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18369 2 074862 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74862ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74931_Ibuprofen_Prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936ap_appltr_prntlbl_chemr.
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74943_Diltiazem
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74986_Doclofenec
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75014_Permethrin_Prntlbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Prntlbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75108_Nifedipine_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75140_Terazosin
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Prntlbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75213_Tretinoin_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256_Desogestrel%20and
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75264_Tretinoin_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75265_Tretinoin_prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75313_Ipratropium
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75611_Famotidine_Prntlbl.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75661_Ibuprofen_Prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75962lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75964lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75968lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75983lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75986lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76003lbl.pdf 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76005_Econazole
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076047lbl.pdf 2008-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76192lbl_Ribavarin_Sandoz.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76203LBL_Ribasphere.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76268_Digoxin_Prntlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076392s008lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076677lbl.pdf 2008-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/076761lbl.pdf 2006-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/076867lbl.pdf 2007-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076886s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077132s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077139Orig1s016lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077239s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077297s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077419lbl.pdf 2012-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077425Orig1s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077460s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077467s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077492Orig1s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077571s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077672s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078080Orig1s005lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078104lbl.pdf 2009-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078158s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/078458Orig1s010lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/078709Orig1s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078830Orig1s000lbl.pdf
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2011-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf
2016-07-05 00:00:00
18785 2 125104 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125104lbl.pdf 2004-
11-24 00:00:00
18786 2 125104 SUPPL 106 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf
2008-10-31 00:00:00
18787 2 125104 SUPPL 283 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125104s283lbl.pdf
2004-11-23 00:00:00
18788 2 125104 SUPPL 438 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf
2011-04-07 00:00:00
18789 2 125104 SUPPL 475 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf
2011-04-07 00:00:00
18790 2 125104 SUPPL 576 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf
2012-01-27 00:00:00
18791 2 125104 SUPPL 840 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf
2013-12-17 00:00:00
18792 2 125104 SUPPL 955 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf
2016-05-20 00:00:00
18793 2 125117 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf
2005-06-07 00:00:00
18794 2 125117 SUPPL 86 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.p
df 2011-04-29 00:00:00
18795 2 125118 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125118s0016lbl.pdf
2007-03-13 00:00:00
18796 2 125118 SUPPL 179 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125118s179lbl.pdf
2015-01-05 00:00:00
18797 2 125141 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf
2006-04-28 00:00:00
18798 2 125141 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf
2009-01-16 00:00:00
18799 2 125141 SUPPL 219 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf
2014-05-28 00:00:00
18800 2 125147 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125147s0000lbl.pdf
2006-09-28 00:00:00
18801 2 125147 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125147s026lbl.pdf
2008-07-14 00:00:00
18802 2 125147 SUPPL 148 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125147s0148lbl.pdf
2012-08-20 00:00:00
18803 2 125147 SUPPL 200 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125147s200lbl.pdf
2015-03-12 00:00:00
18804 2 125151 SUPPL 184 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0184lbl.pdf
2013-06-24 00:00:00
18805 2 125156 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125156lbl.pdf 2006-
07-13 00:00:00
18806 2 125156 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125156s053lbl.pdf
2010-07-06 00:00:00
18807 2 125156 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf
2012-08-15 00:00:00
18808 2 125156 SUPPL 76 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf
2012-08-15 00:00:00
18809 2 125156 SUPPL 81 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125156s081lbl.pdf
2013-02-08 00:00:00
18810 2 125156 SUPPL 105 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf
2014-11-26 00:00:00
18811 2 125156 SUPPL 106 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125156s106lbl.pdf
2015-02-09 00:00:00
18812 2 125160 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125160s000lbl.pdf
2008-05-08 00:00:00
18813 2 125160 SUPPL 92 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125160s092lbl.pdf
2009-12-12 00:00:00
18814 2 125160 SUPPL 111 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125160s111lbl.pdf
2010-08-10 00:00:00
18815 2 125160 SUPPL 174 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0174lbl.pdf
2012-04-20 00:00:00
18816 2 125160 SUPPL 189 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s189lbl.pdf
2012-11-16 00:00:00
18817 2 125160 SUPPL 213 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s213lbl.pdf
2013-10-01 00:00:00
18818 2 125160 SUPPL 215 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s215lbl.pdf
2013-10-22 00:00:00
18819 2 125160 SUPPL 268 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s268lbl.pdf
2016-02-11 00:00:00
18820 2 125164 SUPPL 70 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125164s070lbl.pdf
2015-08-25 00:00:00
18821 2 125164 SUPPL 71 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf
2016-04-29 00:00:00
18822 2 125164 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf
2016-04-29 00:00:00
18823 2 125166 SUPPL 172 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125166s172lbl.pdf
2011-09-23 00:00:00
18824 2 125166 SUPPL 368 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf
2014-05-02 00:00:00
18825 2 125166 SUPPL 413 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125166s413lbl.pdf
2015-12-08 00:00:00
18826 2 125261 SUPPL 99 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf
2013-05-01 00:00:00
18827 2 125268 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125268lbl.pdf 2008-
08-25 00:00:00
18828 2 125268 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125268s0026lbl.pdf
2009-09-18 00:00:00
18829 2 125268 SUPPL 77 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125268s077lbl.pdf
2011-12-06 00:00:00
18830 2 125268 SUPPL 141 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125268s141lbl.pdf
2014-02-11 00:00:00
18831 2 125268 SUPPL 155 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf
2016-04-20 00:00:00
18832 2 125274 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf
2009-06-04 00:00:00
18834 2 125274 SUPPL 105 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s105lbl.pdf
2016-08-02 00:00:00
18835 2 125276 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf 2010-
01-12 00:00:00
18836 2 125276 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf
2011-01-11 00:00:00
18837 2 125276 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf
2011-01-11 00:00:00
18838 2 125276 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf
2011-04-18 00:00:00
18839 2 125276 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf
2011-04-18 00:00:00
18840 2 125276 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0046lbl.pdf
2012-08-15 00:00:00
18841 2 125276 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s064lbl.pdf
2013-05-01 00:00:00
18842 2 125276 SUPPL 92 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s092lbl.pdf
2013-10-21 00:00:00
18843 2 125277 SUPPL 70 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf
2014-04-01 00:00:00
18844 2 125288 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125288s030lbl.pdf
2013-04-09 00:00:00
18845 2 125288 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s062lbl.pdf
2014-10-02 00:00:00
18846 2 125289 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s006lbl.pdf
2009-12-11 00:00:00
18847 2 125289 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s0029lbl.pdf
2011-01-05 00:00:00
18848 2 125289 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf
2013-05-21 00:00:00
18849 2 125289 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf
2013-05-21 00:00:00
18850 2 125289 SUPPL 86 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s086lbl.pdf
2013-05-06 00:00:00
18851 2 125289 SUPPL 103 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s103lbl.pdf
2013-12-30 00:00:00
18852 2 125289 SUPPL 127 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125289s127lbl.pdf
2016-01-12 00:00:00
18853 2 125290 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125290s063lbl.pdf
2015-12-28 00:00:00
18854 2 125291 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125291lbl.pdf 2010-
05-26 00:00:00
18855 2 125291 SUPPL 133 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s133lbl.pdf
2014-05-28 00:00:00
18856 2 125293 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf
2012-04-16 00:00:00
18857 2 125293 SUPPL 81 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125293s081lbl.pdf
2015-07-22 00:00:00
18858 2 125294 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf
2012-08-31 00:00:00
18859 2 125294 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
2014-12-22 00:00:00
18860 2 125319 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf
2009-06-29 00:00:00
18861 2 125319 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s047lbl.pdf
2012-04-02 00:00:00
18862 2 125320 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf
2010-06-02 00:00:00
18863 2 125320 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf
2011-09-20 00:00:00
18864 2 125320 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s007lbl.pdf
2010-11-19 00:00:00
18865 2 125320 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0051lbl.pdf
2012-09-25 00:00:00
18866 2 125320 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0054lbl.pdf
2012-05-01 00:00:00
18867 2 125320 SUPPL 80 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s080lbl.pdf
2013-02-20 00:00:00
18868 2 125320 SUPPL 85 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0085lbl.pdf
2012-09-18 00:00:00
18869 2 125320 SUPPL 155 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s155lbl.pdf
2014-06-04 00:00:00
18870 2 125320 SUPPL 168 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s168lbl.pdf
2015-06-10 00:00:00
18871 2 125320 SUPPL 177 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320Orig1s177lbl.pdf
2016-03-04 00:00:00
18872 2 125326 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf 2009-
10-27 00:00:00
18873 2 125326 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125326s059lbl.pdf
2013-09-27 00:00:00
18874 2 125326 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125326s060lbl.pdf
2014-04-17 00:00:00
18875 2 125327 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125327s020lbl.pdf
2013-04-01 00:00:00
18876 2 125338 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf
2013-12-12 00:00:00
18877 2 125338 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125338s084lbl.pdf
2014-10-21 00:00:00
18878 2 125338 SUPPL 85 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
2015-05-21 00:00:00
18879 2 125338 SUPPL 88 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
2015-05-21 00:00:00
18880 2 125349 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf
2012-12-27 00:00:00
18881 2 125359 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125359lbl.pdf 2011-
11-18 00:00:00
18882 2 125359 SUPPL 88 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125359s088lbl.pdf
2016-03-30 00:00:00
18883 2 125360 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf 2010-
08-06 00:00:00
18884 2 125360 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf 2010-
08-06 00:00:00
18885 2 125360 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125360s007lbl.pdf
2011-07-25 00:00:00
18886 2 125360 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125360s045lbl.pdf
2013-04-16 00:00:00
18887 2 125360 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s066lbl.pdf
2015-11-25 00:00:00
18888 2 125370 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf
2011-03-11 00:00:00
18889 2 125370 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf
2012-04-02 00:00:00
18890 2 125370 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf
2014-04-04 00:00:00
18891 2 125377 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf
2011-03-25 00:00:00
18892 2 125377 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf
2012-10-30 00:00:00
18893 2 125377 SUPPL 72 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf
2015-03-24 00:00:00
18894 2 125377 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf
2016-04-19 00:00:00
18895 2 125387 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s023lbl.pdf
2014-01-28 00:00:00
18896 2 125387 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s036lbl.pdf
2015-08-04 00:00:00
18897 2 125387 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s048lbl.pdf
2015-03-26 00:00:00
18898 2 125387 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s051lbl.pdf
2016-05-25 00:00:00
18899 2 125388 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf
2012-01-13 00:00:00
18900 2 125388 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
2014-11-25 00:00:00
18901 2 125388 SUPPL 78 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
2014-11-25 00:00:00
18902 2 125388 SUPPL 80 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf
2015-08-17 00:00:00
18903 2 125390 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf
2014-07-02 00:00:00
18904 2 125390 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
2015-08-28 00:00:00
18905 2 125390 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf
2015-10-06 00:00:00
18906 2 125399 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.p
df 2011-08-19 00:00:00
18907 2 125409 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s032lbl.pdf
2013-04-16 00:00:00
18908 2 125409 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf
2013-09-30 00:00:00
18909 2 125409 SUPPL 104 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s104lbl.pdf
2015-03-19 00:00:00
18910 2 125409 SUPPL 105 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s105lbl.pdf
2015-06-04 00:00:00
18911 2 125418 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf
2012-08-03 00:00:00
18912 2 125418 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s037lbl.pdf
2016-03-14 00:00:00
18913 2 125427 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf 2013-
02-22 00:00:00
18914 2 125427 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427Orig1s014Lbl.pdf
2013-08-30 00:00:00
18915 2 125433 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125433s000lbledt.pdf
2013-07-22 00:00:00
18916 2 125433 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s005lbl.pdf
2014-02-12 00:00:00
18917 2 125469 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf
2015-04-01 00:00:00
18918 2 125472 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125472s000lbl.pdf
2013-10-25 00:00:00
18919 2 125477 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf 2014-
04-21 00:00:00
18920 2 125477 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf
2015-04-24 00:00:00
18921 2 125486 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486s000lbl.pdf
2013-11-01 00:00:00
18922 2 125486 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125486s010lbledt.pdf
2015-10-06 00:00:00
18923 2 125496 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf
2014-04-23 00:00:00
18924 2 125499 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf
2015-12-28 00:00:00
18925 2 125504 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf
2015-01-22 00:00:00
18926 2 125504 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf
2016-01-26 00:00:00
18927 2 125504 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf
2016-01-26 00:00:00
18928 2 125511 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125511s000lbl.pdf
2015-01-29 00:00:00
18929 2 125514 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s003lbl.pdf
2019-06-05 00:00:00
18930 2 125514 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf
2015-12-18 00:00:00
18931 2 125514 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s005lbl.pdf
2015-10-02 00:00:00
18932 2 125527 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125527s000lbl.pdf
2015-03-04 00:00:00
18933 2 125544 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf
2016-04-05 00:00:00
18934 2 125553 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf
2016-03-04 00:00:00
18936 2 125554 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s019lbl.pdf
2016-05-17 00:00:00
18937 2 125559 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf
2015-07-24 00:00:00
18938 2 125561 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125561s000lbl.pdf
2015-12-08 00:00:00
18939 2 200045 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf
2010-12-26 00:00:00
18940 2 200045 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf
2011-10-20 00:00:00
18941 2 200045 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s009lbl.pdf
2011-11-04 00:00:00
18942 2 200045 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s010lbl.pdf
2012-02-06 00:00:00
18943 2 200045 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200045s014lbl.pdf
2013-11-04 00:00:00
18944 2 200045 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s016lbl.pdf
2015-04-02 00:00:00
18945 2 200045 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s017lbl.pdf
2015-12-28 00:00:00
18946 2 200153 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200153s000lbl.pdf
2013-05-09 00:00:00
18947 2 200175 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s001lbl.pdf
2011-04-11 00:00:00
18948 2 200175 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s003lbl.pdf
2011-06-29 00:00:00
18949 2 200175 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s008lbl.pdf
2012-01-23 00:00:00
18950 2 200175 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s011lbl.pdf
2012-10-02 00:00:00
18951 2 200175 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s019lbl.pdf
2014-07-01 00:00:00
18952 2 200179 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200179s002lbl.pdf
2014-05-02 00:00:00
18953 2 200271 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200271lbl.pdf 2015-
10-02 00:00:00
18954 2 200327 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s001lbl.pdf
2011-06-30 00:00:00
18955 2 200327 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s003lbl.pdf
2011-03-14 00:00:00
18956 2 200327 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s008lbl.pdf
2012-10-24 00:00:00
18957 2 200327 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s009lbl.pdf
2013-06-04 00:00:00
18958 2 200327 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s011lbl.pdf
2013-12-17 00:00:00
18959 2 200327 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s015lbl.pdf
2015-09-04 00:00:00
18960 2 200327 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200327s016s017lbl.pdf
2016-06-01 00:00:00
18961 2 200533 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf
2011-08-26 00:00:00
18962 2 200533 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s002lbl.pdf
2012-07-12 00:00:00
18963 2 200534 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200534s000lbl.pdf
2010-10-21 00:00:00
18964 2 200535 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf
2013-08-27 00:00:00
18965 2 200582 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200582s000lbl.pdf
2011-02-04 00:00:00
18966 2 200582 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200582s002lbl.pdf
2016-02-25 00:00:00
18967 2 200603 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s000lbl.pdf
2010-10-29 00:00:00
18968 2 200603 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf
2012-05-01 00:00:00
18969 2 200603 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf
2012-05-01 00:00:00
18970 2 200603 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf
2013-07-09 00:00:00
18971 2 200603 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603Org1s016lbl.pdf
2013-09-24 00:00:00
18972 2 200656 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200656s000lbl.pdf
2014-08-26 00:00:00
18973 2 200671 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s000lbl.pdf
2015-09-14 00:00:00
18974 2 200671 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s002lbl.pdf
2015-12-10 00:00:00
18975 2 200678 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf
2010-11-12 00:00:00
18976 2 200678 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf
2013-06-04 00:00:00
18977 2 200678 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf
2015-09-04 00:00:00
18978 2 200738 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200738s000lbl.pdf
2011-04-18 00:00:00
18979 2 200740 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200740s000lbl.pdf
2012-10-04 00:00:00
18980 2 200795 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200795s005lbl.pdf
2014-05-12 00:00:00
18981 2 200796 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s000lbl.pdf
2011-03-04 00:00:00
18982 2 200796 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s002lbl.pdf
2011-12-14 00:00:00
18983 2 200796 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200796s003lbl.pdf
2012-10-05 00:00:00
18984 2 200796 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200796s006lbl.pdf
2014-07-24 00:00:00
18985 2 200890 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s001lbl.pdf
2010-07-12 00:00:00
18986 2 200936 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200936Orig1s000lbl.pdf
2013-11-19 00:00:00
18987 2 201023 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf 2010-
06-17 00:00:00
18988 2 201023 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201023s003lbl.pdf
2012-10-05 00:00:00
18989 2 201023 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201023s015lbl.pdf
2015-06-19 00:00:00
18990 2 201152 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf
2011-03-29 00:00:00
18991 2 201152 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s004lbl.pdf
2012-11-08 00:00:00
18992 2 201152 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s005lbl.pdf
2012-10-04 00:00:00
18993 2 201152 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201152s007lbl.pdf
2014-01-28 00:00:00
18994 2 201153 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.p
df 2011-03-28 00:00:00
18995 2 201195 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201195s000lbl.pdf
2011-06-10 00:00:00
18996 2 201195 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201195s004lbl.pdf
2013-04-09 00:00:00
18997 2 201277 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201277s010lbl.pdf
2015-09-21 00:00:00
18998 2 201277 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201277s011lbl.pdf
2016-05-05 00:00:00
18999 2 201280 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201280lbl.pdf 2011-
05-06 00:00:00
19000 2 201280 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s002lbl.pdf
2012-05-23 00:00:00
19001 2 201280 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf
2012-08-15 00:00:00
19002 2 201280 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf
2012-10-01 00:00:00
19003 2 201280 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201280s006lbl.pdf
2013-06-25 00:00:00
19004 2 201280 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s011lbl.pdf
2015-07-30 00:00:00
19005 2 201281 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201281s000lbl.pdf
2012-02-01 00:00:00
19006 2 201281 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s004lbl.pdf
2013-09-09 00:00:00
19007 2 201281 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s006lbl.pdf
2014-07-31 00:00:00
19008 2 201281 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s008lbl.pdf
2015-07-30 00:00:00
19009 2 201292 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s000lbl.pdf
2013-07-12 00:00:00
19010 2 201292 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s006lbl.pdf
2015-11-12 00:00:00
19011 2 201292 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s007lbl.pdf
2016-04-19 00:00:00
19012 2 201292 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s008lbl.pdf
2015-12-31 00:00:00
19013 2 201292 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s009lbl.pdf
2016-04-27 00:00:00
19014 2 201361 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201361Orig1s000lbl.pdf
2016-07-21 00:00:00
19015 2 201367 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf
2011-03-07 00:00:00
19016 2 201373 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201373Orig1s006lbl.pdf
2016-06-17 00:00:00
19017 2 201444 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201444s000lbl.pdf
2011-01-20 00:00:00
19018 2 201517 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201517s000lbl.pdf
2011-06-28 00:00:00
19019 2 201525 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201525s000lbl.pdf
2011-06-30 00:00:00
19020 2 201525 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf
2012-03-16 00:00:00
19021 2 201525 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s003lbl.pdf
2014-04-25 00:00:00
19022 2 201525 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf
2014-11-07 00:00:00
19023 2 201525 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf
2014-11-07 00:00:00
19024 2 201532 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf
2015-11-04 00:00:00
19025 2 201532 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf
2016-01-28 00:00:00
19026 2 201573 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf
2013-09-19 00:00:00
19027 2 201635 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201635s000lbl.pdf
2013-08-21 00:00:00
19028 2 201655 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201655s004lbl.pdf
2013-01-14 00:00:00
19029 2 201657 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201657s000lbl.pdf
2014-10-23 00:00:00
19030 2 201688 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s002lbl.pdf
2014-04-28 00:00:00
19031 2 201688 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201688s006lbl.pdf
2015-10-08 00:00:00
19032 2 201699 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf
2013-04-09 00:00:00
19033 2 201739 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201739s000lbl.pdf
2012-08-15 00:00:00
19034 2 201743 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201743s001lbl.pdf
2016-06-01 00:00:00
19035 2 201811 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.pdf
2015-04-14 00:00:00
19036 2 201849 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf
2015-12-02 00:00:00
19037 2 201917 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf 2011-
05-23 00:00:00
19038 2 201917 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf
2012-06-26 00:00:00
19039 2 201917 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s007lbl.pdf
2012-12-17 00:00:00
19040 2 201917 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s008lbl.pdf
2013-04-29 00:00:00
19041 2 201917 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s010lbl.pdf
2013-10-28 00:00:00
19042 2 201922 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201922s000lbl.pdf
2012-07-13 00:00:00
19043 2 202008 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202008s000lbl.pdf
2012-04-09 00:00:00
19044 2 202008 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202008s020lbl.pdf
2013-12-17 00:00:00
19045 2 202020 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202020s000lbl.pdf
2012-07-30 00:00:00
19046 2 202022 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s002lbl.pdf
2012-12-10 00:00:00
19047 2 202022 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s008lbledt.pdf
2015-08-27 00:00:00
19048 2 202057 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202057S000lbl.pdf
2012-07-30 00:00:00
19049 2 202067 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf
2011-10-24 00:00:00
19050 2 202067 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.p
df 2015-05-12 00:00:00
19051 2 202080 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf
2011-06-27 00:00:00
19052 2 202080 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202080s002lbl.pdf
2014-01-17 00:00:00
19053 2 202088 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s000lbl.pdf
2011-06-16 00:00:00
19054 2 202088 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s001lbl.pdf
2011-10-20 00:00:00
19055 2 202088 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088s005lbl.pdf
2013-06-18 00:00:00
19056 2 202091 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202091s000lbl.pdf
2013-02-21 00:00:00
19057 2 202091 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202091Orig1s002lbl.pdf
2014-06-04 00:00:00
19058 2 202100 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s001lbl.pdf
2013-05-21 00:00:00
19059 2 202100 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100Orig1s005lbl.pdf
2015-07-22 00:00:00
19060 2 202102 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202102s000lbl.pdf
2015-04-29 00:00:00
19061 2 202107 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202107s000lbl.pdf
2012-02-22 00:00:00
19062 2 202123 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf
2011-08-11 00:00:00
19063 2 202123 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s003lbl.pdf
2013-01-30 00:00:00
19064 2 202123 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf
2013-06-25 00:00:00
19065 2 202123 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s012lbl.pdf
2013-12-17 00:00:00
19066 2 202123 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf
2014-06-10 00:00:00
19067 2 202123 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202123s020lbl.pdf
2015-05-12 00:00:00
19068 2 202123 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf
2016-02-19 00:00:00
19069 2 202129 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf
2014-11-18 00:00:00
19070 2 202145 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202145Orig1lbl.pdf
2013-10-02 00:00:00
19071 2 202155 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf
2012-12-31 00:00:00
19072 2 202155 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s002lbl.pdf
2014-01-31 00:00:00
19073 2 202155 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s003lbl.pdf
2014-03-19 00:00:00
19074 2 202155 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202155Orig1s004lbl.pdf
2013-11-19 00:00:00
19075 2 202155 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s006lbl.pdf
2014-09-09 00:00:00
19076 2 202155 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s010lbl.pdf
2015-06-19 00:00:00
19077 2 202155 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s011lbl.pdf
2015-09-11 00:00:00
19078 2 202192 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf 2011-
11-16 00:00:00
19079 2 202192 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf
2013-06-18 00:00:00
19080 2 202192 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf
2014-07-28 00:00:00
19081 1 019675 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,
020251s019ltr.pdf 2009-11-12 00:00:00
19082 14 019676 SUPPL 13 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19083 14 019676 SUPPL 20 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19084 14 019676 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19085 14 019676 SUPPL 42 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19086 1 019677 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019677s006ltr.pdf
2009-04-03 00:00:00
19087 1 019678 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019677s005,019678s005l
tr.pdf 2005-12-15 00:00:00
19088 1 019680 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019680Orig1s033ltr.pdf
2014-06-23 00:00:00
19092 1 019680 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,
018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf2013-03-01 00:00:00
19093 1 019680 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf
2004-05-27 00:00:00
19098 1 019681 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf
2004-05-27 00:00:00
19099 1 019684 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019684s024ltr.pdf
2011-10-03 00:00:00
19100 1 019684 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019684Orig1s027ltr.pdf
2014-05-08 00:00:00
19101 1 019684 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019684Orig1s029ltr.pdf
2015-01-12 00:00:00
19102 1 019697 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653s045,019697s041l
tr.pdf 2008-06-03 00:00:00
19103 1 019697 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697
Orig1s052,021690Orig1s001ltr.pdf 2015-05-04 00:00:00
19106 1 019699 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19699s013ltr.pdf
2004-09-29 00:00:00
19107 1 019700 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19700s019ltr.pdf
2002-02-08 00:00:00
19108 1 019700 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19700S023,024ltr.pdf
2005-03-11 00:00:00
19109 1 019708 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19708s013ltr.pdf
2004-09-29 00:00:00
19110 1 019708 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019630s026,019708s016l
tr.pdf 2005-09-08 00:00:00
19111 1 019710 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s032ltr.pdf
2008-04-28 00:00:00
19112 1 019716 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s022ltr.pdf
2006-09-18 00:00:00
19113 1 019716 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,
019716s030ltr.pdf 2014-08-14 00:00:00
19114 14 019717 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19115 14 019717 SUPPL 32 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19116 14 019717 SUPPL 52 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19117 14 019717 SUPPL 58 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19118 14 019717 SUPPL 123 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19119 14 019717 SUPPL 135 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19120 1 019726 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf
1998-07-27 00:00:00
19121 1 019726 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s34ltr.pdf
2002-02-05 00:00:00
19122 1 019726 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf
2002-02-28 00:00:00
19123 1 019726 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr02
0ltr.pdf 2004-06-25 00:00:00
19124 1 019726 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052lt
r.pdf 2010-01-07 00:00:00
19125 1 019726 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,0
20578Orig1s034,s035ltr.pdf 2013-06-20 00:00:00
19126 1 019732 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr02
3ltr.pdf 2003-09-25 00:00:00
19127 1 019732 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20
011s028,20517s016,20708s018ltr.pdf 2004-01-14 00:00:00
19128 1 019732 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
222420517181920708202120011tr.pdf 2005-10-20 00:00:00
19129 1 019732 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,
s035,s036,020517s024,s028,s029ltr.pdf 2010-05-04 00:00:00
19130 1 019732 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,
s035,s036,020517s024,s028,s029ltr.pdf 2010-05-04 00:00:00
19131 1 019732 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019732s038ltr.pdf
2012-02-23 00:00:00
19132 1 019734 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019734s009ltr.pdf
2007-07-05 00:00:00
19133 1 019734 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019734s015ltr.pdf
2010-01-15 00:00:00
19134 1 019735 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735slr051ltr.pdf
2004-03-10 00:00:00
19135 1 019735 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf
2004-09-17 00:00:00
19136 1 019735 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf
2004-09-17 00:00:00
19137 1 019735 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s054ltr.pdf
2006-01-30 00:00:00
19138 1 019735 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s057ltr.pdf
2007-07-05 00:00:00
19139 1 019737 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19737s007ltr.pdf
2002-06-03 00:00:00
19140 1 019758 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s45ltr.pdf
2002-01-14 00:00:00
19141 1 019758 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s048ltr.pdf
2002-07-05 00:00:00
19142 1 019758 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s053ltr.pdf
2008-11-06 00:00:00
19143 1 019758 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s057ltr.pdf
2005-12-13 00:00:00
19144 1 019758 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s058ltr.pdf
2008-07-01 00:00:00
19145 1 019758 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077lt
r.pdf 2015-09-16 00:00:00
19146 1 019758 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s062ltr.pdf
2010-01-26 00:00:00
19147 1 019758 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019758s063ltr.pdf
2011-10-24 00:00:00
19148 1 019758 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s065ltr.pdf
2010-12-06 00:00:00
19149 1 019758 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s
070ltr.pdf 2013-03-25 00:00:00
19150 1 019758 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s069ltr.pdf
2013-07-22 00:00:00
19151 1 019758 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s
070ltr.pdf 2013-03-25 00:00:00
19152 1 019758 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077lt
r.pdf 2015-09-16 00:00:00
19153 1 019758 SUPPL 78 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s078ltr.pdf
2015-10-13 00:00:00
19154 1 019763 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019763s016ltr.pdf
2011-03-25 00:00:00
19155 1 019763 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019763s017ltr.pdf
2012-03-05 00:00:00
19156 14 019764 SUPPL 20 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19157 14 019764 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19158 14 019764 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19159 14 019764 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19160 14 019764 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19161 14 019764 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19162 1 019766 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf
1998-07-10 00:00:00
19163 1 019766 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s27ltr.pdf
1998-03-31 00:00:00
19164 1 019766 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf
1998-07-10 00:00:00
19165 1 019766 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19766s32ltr.pdf
1999-08-05 00:00:00
19166 1 019766 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19766S40LTR.PDF
2000-04-27 00:00:00
19167 1 019766 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s51ltr.pdf
2002-05-06 00:00:00
19168 1 019766 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s52ltr.pdf
2002-03-21 00:00:00
19169 1 019766 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766se5-
056ltr.pdf 2002-10-18 00:00:00
19170 1 019766 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766se1-
058ltr.pdf 2003-05-29 00:00:00
19171 1 019766 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf
2003-09-29 00:00:00
19172 1 019766 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf
2004-02-25 00:00:00
19173 1 019766 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf
2004-02-25 00:00:00
19174 1 019766 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s070ltr.pdf
2005-05-20 00:00:00
19175 1 019766 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s075ltr.pdf
2007-12-03 00:00:00
19176 1 019766 SUPPL 76 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019766s076ltr.pdf
2008-06-13 00:00:00
19177 1 019766 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf
2011-06-08 00:00:00
19178 1 019766 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15others
ltr.pdf 2011-06-17 00:00:00
19179 1 019766 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s080ltr.pdf
2010-04-13 00:00:00
19180 1 019766 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf
2011-06-08 00:00:00
19181 1 019766 SUPPL 85 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766s085ltr.pdf
2012-02-29 00:00:00
19182 1 019766 SUPPL 87 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088lt
r.pdf 2012-11-05 00:00:00
19183 1 019771 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s026ltr.pdf
2006-04-20 00:00:00
19184 1 019771 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019771s031ltr.pdf
2008-06-23 00:00:00
19185 1 019771 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019771s036ltr.pdf
2010-09-07 00:00:00
19186 14 019774 SUPPL 9 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19187 14 019774 SUPPL 19 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19188 14 019774 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19189 14 019774 SUPPL 26 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19190 14 019774 SUPPL 28 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19191 14 019774 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19192 1 019777 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-
044,slr042ltr.pdf 2003-07-06 00:00:00
19193 1 019777 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19777slr043ltr.pdf
2004-04-07 00:00:00
19194 1 019777 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-
044,slr042ltr.pdf 2003-07-06 00:00:00
19195 1 019777 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019777s050,
019888s041LTR.pdf 2006-06-20 00:00:00
19196 1 019777 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s056ltr.pdf
2010-01-07 00:00:00
19197 1 019777 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s060ltr.pdf
2012-04-02 00:00:00
19198 1 019777 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s061ltr.pdf
2012-11-05 00:00:00
19199 1 019777 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019777Orig1s063ltr.pdf
2013-11-07 00:00:00
19200 1 019777 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s064ltr.pdf
2014-12-30 00:00:00
19201 1 019777 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019777Orig1s073ltr.pdf
2015-08-27 00:00:00
19202 1 019778 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_appltrs.pdf
1998-10-28 00:00:00
19203 1 019778 SUPPL 32 0

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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019778s047ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019785s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019805Orig1s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19810slr067,080ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810se5074ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s083ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s084LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019810s085ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s051ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s052ltr.pdf
2012-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019813Orig1s056ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s065ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821scp010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019821s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19822slr006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019826s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019829s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19830slr008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s007lbl.pdf
2015-03-03 00:00:00
19334 2 202344 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf
2015-04-10 00:00:00
19336 2 202379 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202379lbl.pdf 2011-
04-28 00:00:00
19337 2 202379 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s005lbl.pdf
2012-12-14 00:00:00
19338 2 202379 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202379s007lbl.pdf
2013-09-17 00:00:00
19339 2 202379 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202379s009lbl.pdf
2014-05-15 00:00:00
19340 2 202379 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s016lbl.pdf
2015-03-24 00:00:00
19341 2 202379 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s018lbl.pdf
2015-05-27 00:00:00
19342 2 202379 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s021lbl.pdf
2015-12-15 00:00:00
19343 2 202402 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202402Orig1s000lbl.pdf
2016-04-11 00:00:00
19344 2 202429 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf
2013-07-05 00:00:00
19345 2 202429 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s004lbl.pdf
2014-03-20 00:00:00
19346 2 202429 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s005lbl.pdf
2014-02-07 00:00:00
19347 2 202429 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s010lbl.pdf
2016-05-11 00:00:00
19348 2 202439 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s000lbl.pdf
2014-06-03 00:00:00
19349 2 202439 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202439s008lbl.pdf
2013-08-09 00:00:00
19350 2 202450 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202450s000lbl.pdf
2012-07-24 00:00:00
19351 2 202450 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202450s002lbl.pdf
2014-07-22 00:00:00
19352 2 202450 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202450s005lbl.pdf
2015-04-07 00:00:00
19353 2 202497 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf
2012-08-09 00:00:00
19354 2 202513 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202513s005lbl.pdf
2015-07-13 00:00:00
19355 2 202514 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202514s001lbl.pdf
2013-02-26 00:00:00
19356 2 202514 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf
2015-09-08 00:00:00
19357 2 202515 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515Orig1s000Lbl.pdf
2011-11-14 00:00:00
19358 2 202535 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202535lbl.pdf 2012-
07-18 00:00:00
19359 2 202570 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf
2011-08-26 00:00:00
19360 2 202570 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s013lbl.pdf
2015-03-24 00:00:00
19361 2 202570 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf
2016-03-11 00:00:00
19362 2 202573 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202573Orig1s000lbl.pdf
2015-02-17 00:00:00
19363 2 202611 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s005lbl.pdf
2015-11-04 00:00:00
19364 2 202611 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s006lbl.pdf
2015-08-11 00:00:00
19365 2 202620 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202620Orig1lbl.pdf
2014-07-31 00:00:00
19366 2 202667 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202667s000lbl.pdf
2012-02-06 00:00:00
19367 2 202688 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202688Orig1s000lbl.pdf
2015-10-15 00:00:00
19368 2 202714 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf 2012-
07-20 00:00:00
19369 2 202714 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s008lbl.pdf
2015-04-07 00:00:00
19370 2 202714 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf
2016-07-06 00:00:00
19371 2 202723 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202723Orig1s000lbl.pdf
2013-09-19 00:00:00
19372 2 202736 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202736Orig1s000lbl.pdf
2012-02-09 00:00:00
19373 2 202763 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000lbl.pdf
2012-02-17 00:00:00
19374 2 202784 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202784Orig1s000lbl.pdf
2015-11-25 00:00:00
19375 2 202788 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s002lbl.pdf
2012-08-31 00:00:00
19376 2 202788 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf
2015-01-09 00:00:00
19377 2 202788 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf
2015-01-09 00:00:00
19378 2 202806 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf
2014-01-10 00:00:00
19379 2 202806 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf
2015-11-20 00:00:00
19380 2 202806 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202806s005lbl.pdf
2016-06-21 00:00:00
19381 2 202810 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000lbl.pdf
2012-10-22 00:00:00
19382 2 202810 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202810s005lbl.pdf
2015-12-08 00:00:00
19383 2 202811 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202811s000lbl.pdf
2012-08-31 00:00:00
19384 2 202811 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf
2015-11-25 00:00:00
19385 2 202813 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202813s000lbl.pdf
2012-03-27 00:00:00
19386 2 202813 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf
2014-12-19 00:00:00
19387 2 202833 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202833lbl.pdf 2012-
01-25 00:00:00
19388 2 202833 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s005lbl.pdf
2015-10-08 00:00:00
19389 2 202834 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202834s001lbl.pdf
2013-07-11 00:00:00
19390 2 202834 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf
2014-02-19 00:00:00
19391 2 202834 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf
2015-06-23 00:00:00
19392 2 202834 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s006lbl.pdf
2014-11-20 00:00:00
19393 2 202872 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf 2012-
10-01 00:00:00
19394 2 202880 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880s000lbl.pdf
2013-10-25 00:00:00
19395 2 202880 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf
2014-08-20 00:00:00
19396 2 202895 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.p
df 2013-04-29 00:00:00
19397 2 202895 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.p
df 2013-02-06 00:00:00
19398 2 202895 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.p
df 2013-02-06 00:00:00
19399 2 202895 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.p
df 2013-11-08 00:00:00
19400 2 202895 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.p
df 2015-05-29 00:00:00
19401 2 202964 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202964Orig1s000lbl.pdf
2016-05-05 00:00:00
19402 2 202971 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202971s000lbl.pdf
2013-03-15 00:00:00
19403 2 202971 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s003lbl.pdf
2014-12-10 00:00:00
19404 2 202971 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s008lbl.pdf
2016-01-22 00:00:00
19405 2 202992 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf
2012-09-14 00:00:00
19406 2 202992 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202992s001lbl.pdf
2014-10-21 00:00:00
19407 2 203039 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203039Orig1s000lbl.pdf
2015-12-01 00:00:00
19408 2 203045 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/203045s000lbl.pdf
2011-12-23 00:00:00
19409 2 203045 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.p
df 2012-03-28 00:00:00
19410 2 203045 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.p
df 2012-04-20 00:00:00
19411 2 203045 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.p
df 2013-04-09 00:00:00
19412 2 203045 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s007lbl.pdf
2013-08-06 00:00:00
19413 2 203045 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s008lbl.pdf
2013-10-25 00:00:00
19414 2 203049 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s005lbl.pdf
2016-06-01 00:00:00
19415 2 203058 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203058Orig1s000lbl.pdf
2014-09-23 00:00:00
19416 2 203085 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203085lbl.pdf 2012-
09-27 00:00:00
19417 2 203085 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203085s001lbl.pdf
2013-06-04 00:00:00
19418 2 203093 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203093s000lbl.pdf
2014-09-26 00:00:00
19419 2 203094 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf
2014-10-03 00:00:00
19420 2 203098 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203098s000lbl.pdf
2013-02-01 00:00:00
19421 2 203098 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203098s002lbl.pdf
2014-06-23 00:00:00
19422 2 203100 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf
2012-08-28 00:00:00
19423 2 203100 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s004lbl.pdf
2013-10-08 00:00:00
19424 2 203100 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s011lbl.pdf
2014-12-19 00:00:00
19425 2 203100 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf
2016-02-23 00:00:00
19426 2 203108 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203108s003lbl.pdf
2016-06-13 00:00:00
19427 2 203109 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203109s000lbl.pdf
2012-08-31 00:00:00
19428 2 203109 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s
006,203109s003s004lbl.pdf 2014-02-03 00:00:00
19429 2 203109 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,2031
09s009lbl.pdf 2015-05-12 00:00:00
19430 2 203137 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203137s000lbl.pdf
2013-10-31 00:00:00
19431 2 203137 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203137s002lbl.pdf
2014-12-10 00:00:00
19432 2 203137 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf
2016-04-08 00:00:00
19434 2 203152 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203152Orig1s000lbl.pdf
2015-12-11 00:00:00
19435 2 203155 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf
2012-09-14 00:00:00
19436 2 203159 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s000lbl.pdf
2013-01-11 00:00:00
19437 2 203159 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s001lbledt1.pdf
2013-08-09 00:00:00
19438 2 203159 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s002lbledt1.pdf
2013-09-17 00:00:00
19439 2 203168 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203168s000lbl.pdf
2013-04-09 00:00:00
19440 2 203188 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188lbl.pdf 2012-
01-31 00:00:00
19441 2 203188 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188s001lbl.pdf
2012-08-29 00:00:00
19442 2 203188 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s007lbl.pdf
2014-06-17 00:00:00
19443 2 203188 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014s015lbl.pdf
2015-01-09 00:00:00
19444 2 203188 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203188s017lbl.pdf
2015-03-20 00:00:00
19445 2 203195 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203195s001lbl.pdf
2013-04-01 00:00:00
19446 2 203214 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.pdf
2014-02-25 00:00:00
19447 2 203214 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf
2014-04-01 00:00:00
19448 2 203214 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s007lbl.pdf
2014-05-12 00:00:00
19449 2 203231 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf
2013-08-06 00:00:00
19450 2 203231 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf
2014-12-11 00:00:00
19451 2 203231 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf
2016-03-29 00:00:00
19452 2 203260 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203260Orig1s000lbl.pdf
2014-01-13 00:00:00
19453 2 203313 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203313lbl.pdf 2020-
03-23 00:00:00
19454 2 203314 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf 2020-
03-23 00:00:00
19455 2 203324 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf
2016-04-19 00:00:00
19457 2 203340 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203340lbl.pdf 2013-
05-10 00:00:00
19458 2 203341 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf 2012-
09-04 00:00:00
19459 2 203341 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf
2015-10-06 00:00:00
19460 2 203341 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf
2016-04-05 00:00:00
19461 2 203388 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203388lbl.pdf 2012-
01-30 00:00:00
19462 2 203388 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.
pdf 2015-05-27 00:00:00
19463 2 203388 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.
pdf 2015-05-27 00:00:00
19464 2 203414 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203414s005lbl.pdf
2015-09-21 00:00:00
19465 2 203415 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf 2012-
08-31 00:00:00
19466 2 203415 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203415s001lbl.pdf
2013-03-26 00:00:00
19467 2 203415 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s006lbl.pdf
2015-09-21 00:00:00
19468 2 203415 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s007lbl.pdf
2015-10-08 00:00:00
19469 2 203441 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203441Orig1s000lbl.pdf
2012-12-27 00:00:00
19470 2 203441 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203441s002lbl.pdf
2014-06-30 00:00:00
19471 2 203469 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469lbl.pdf 2012-
12-14 00:00:00
19472 2 203469 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf
2013-12-20 00:00:00
19473 2 203469 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s021lbl.pdf
2016-06-06 00:00:00
19474 2 203479 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf
2014-01-13 00:00:00
19475 2 203479 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf
2013-08-27 00:00:00
19476 2 203479 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf
2015-09-16 00:00:00
19477 2 203491 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s000lbl.pdf
2012-10-17 00:00:00
19478 2 203496 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf
2013-12-23 00:00:00
19479 2 203510 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203510s000lbl.pdf
2013-03-26 00:00:00
19480 2 203551 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551s001lbl.pdf
2013-11-04 00:00:00
19481 2 203551 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203551s002lbl.pdf
2014-09-19 00:00:00
19482 2 203567 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203567s000lbl.pdf
2014-06-10 00:00:00
19483 2 203567 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf
2015-03-20 00:00:00
19484 2 203568 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203568s000lbl.pdf
2013-01-30 00:00:00
19485 2 203568 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203568s004lbl.pdf
2015-03-03 00:00:00
19486 2 203585 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s001lbl.pdf
2014-02-11 00:00:00
19487 2 203585 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203585s004lbl.pdf
2016-06-17 00:00:00
19488 2 203595 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203595s000lbl.pdf
2013-01-23 00:00:00
19489 2 203667 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s002lbl.pdf
2013-07-12 00:00:00
19490 2 203696 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203696s001lbl.pdf
2013-11-05 00:00:00
19491 2 203752 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203752lbl.pdf 2012-
10-29 00:00:00
19492 2 203794 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000lbl.pdf
2012-10-17 00:00:00
19493 2 203794 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf
2014-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203826s000lbl.pdf
2012-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203849Orig1s000MG.pdf
2015-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf
2012-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf
2013-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf
2014-02-19 00:00:00
19499 2 203858 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf
2014-08-12 00:00:00
19500 2 203858 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf
2015-04-24 00:00:00
19501 2 203858 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf
2016-05-25 00:00:00
19502 2 203922 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203922s000lbl.pdf
2012-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203923s000lbl.pdf
2012-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203971lbl.pdf 2013-
05-15 00:00:00
19505 2 203971 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203971s007lbl.pdf
2016-03-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf
2012-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s
002s004s005lbl.pdf 2014-02-21 00:00:00
19508 2 203985 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pd
f 2014-07-02 00:00:00
19509 2 203985 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203985s008lbl.pdf
2015-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203993s000lbl.pdf
2012-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.p
df 2015-05-12 00:00:00
19512 2 204026 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf 2013-
02-08 00:00:00
19513 2 204026 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf
2014-03-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf
2015-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204031s000lbl.pdf
2014-03-13 00:00:00
19516 2 204042 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s006lbl.pdf
2015-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s013lbl.pdf
2015-12-08 00:00:00
19518 2 204042 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf
2016-05-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204061s000lbl.pdf
2013-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf
2014-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf
2014-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s014lbl.pdf
2016-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204078s000lbl.pdf
2013-06-04 00:00:00
19524 2 204078 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204078s007lbl.pdf
2015-10-22 00:00:00
19526 2 204096 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096s000lbl.pdf
2013-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf
2015-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdf
2013-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204137Orig1s000lbl.pdf
2016-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf
2015-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204153s000lbl.pdf
2013-11-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204154Orig1s000lbl.pdf
2014-10-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204168s000lbl.pdf
2013-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204223s000lbl.pdf
2013-10-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf
2015-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf
2015-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204251s000lbl.pdf
2013-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204251s006lbl.pdf
2015-11-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf
2013-05-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s002lbl.pdf
2015-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204286s001lbl.pdf
2014-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204307s000lbl.pdf
2013-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf
2014-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf
2014-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204312Origs000lbl.pdf
2016-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204353s000lbl.pdf
2014-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s003lbl.pdf
2015-09-11 00:00:00
19549 2 204353 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s010lbl.pdf
2016-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204354Orig1s000lbl.pdf
2015-12-01 00:00:00
19551 2 204384 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204384s004lbl.pdf
2014-10-21 00:00:00
19552 2 204384 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s005lbl.pdf
2015-05-21 00:00:00
19553 2 204384 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s006lbl.pdf
2015-12-15 00:00:00
19554 2 204410 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s002lbl.pdf
2015-11-19 00:00:00
19555 2 204410 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s006lbl.pdf
2016-02-18 00:00:00
19556 2 204412 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204412s000lbl.pdf
2013-02-05 00:00:00
19557 2 204412 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s003lbl.pdf
2014-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204421Orig1s000lbl.pdf
2015-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204426s000lbl.pdf
2013-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204427s000lbl.pdf
2014-07-08 00:00:00
19561 2 204431 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204431Orig1s000lbl.pdf
2015-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204442Orig1s000lbl.pdf
2016-05-26 00:00:00
19563 2 204447 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204447s000lbl.pdf
2013-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s005lbl.pdf
2014-07-29 00:00:00
19565 2 204485 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s000lbl.pdf
2014-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s001lbl.pdf
2015-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204485Orig1s002lbl.pdf
2015-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf
2013-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf
2014-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf
2014-08-14 00:00:00
19571 2 204569 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf
2014-11-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204592s000lbl.pdf
2013-10-22 00:00:00
19573 2 204592 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf
2014-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf
2014-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s002lbl.pdf
2014-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf
2014-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf
2015-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf
2016-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf
2016-03-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf
2015-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204630s000lbl.pdf
2016-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204655Orig1s002lbl.pdf
2015-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf
2013-12-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf
2015-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s001lbl.pdf
2014-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s000lbl.pdf
2013-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204708lbl.pdf 2013-
08-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204708s005lbl.pdf
2016-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s003lbl.pdf
2016-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf
2014-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s001lbl.pdf
2016-07-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204767s000lbl.pdf
2015-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204768s000lbl.pdf
2014-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf
2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204781s000lbl.pdf
2013-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204790lbl.pdf 2013-
08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s002lbl.pdf
2015-01-08 00:00:00
19601 2 204790 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf
2015-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790Orig1s008lbl.pdf
2016-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf
2014-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204822s000lbl.pdf
2014-05-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000Lbl.pdf
2013-10-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204824s004lbl.pdf
2016-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204886s000lbl.pdf
2014-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204886s002lbl.pdf
2015-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s000lbl.pdf
2015-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s001lbl.pdf
2015-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf
2014-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf
2015-10-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205049Orig1lbl.pdf
2016-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205060s000lbl.pdf
2014-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf
2013-12-23 00:00:00
19620 2 205065 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf
2016-04-08 00:00:00
19621 2 205075 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205075Orig1s000lbl.pdf
2016-05-26 00:00:00
19622 2 205095 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf
2016-05-20 00:00:00
19623 2 205098 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205098s001lbl.pdf
2014-07-03 00:00:00
19624 2 205123 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s001lbl.pdf
2013-12-06 00:00:00
19625 2 205123 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s003lbl.pdf
2014-09-09 00:00:00
19626 2 205123 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s010lbl.pdf
2016-03-03 00:00:00
19627 2 205123 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s011lbl.pdf
2016-05-23 00:00:00
19628 2 205208 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205208s000lbl.pdf
2013-10-17 00:00:00
19629 2 205208 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205208Orig1s001lbl.pdf
2014-07-29 00:00:00
19630 2 205239 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205239Orig1s000lbl.pdf
2016-03-04 00:00:00
19631 2 205266 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf
2016-05-17 00:00:00
19632 2 205352 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s000lbl_correct
ed.pdf 2014-01-28 00:00:00
19633 2 205352 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s001lbl.pdf
2014-09-23 00:00:00
19634 2 205352 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s004lbl.pdf
2015-07-22 00:00:00
19635 2 205352 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s005lbl.pdf
2015-08-26 00:00:00
19636 2 205379 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205379Orig1s000lbl.pdf
2015-11-25 00:00:00
19637 2 205382 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205382s000lbl.pdf
2014-05-02 00:00:00
19638 2 205382 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205382s002lbl.pdf
2016-02-26 00:00:00
19639 2 205383 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205383Orig1s000lbl.pdf
2015-04-28 00:00:00
19640 2 205388 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205388s000lbl.pdf
2014-06-03 00:00:00
19641 2 205388 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205388s001lbl.pdf
2016-06-24 00:00:00
19642 2 205395 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s001lbl.pdf
2016-04-27 00:00:00
19643 2 205410 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205410s000lbl.pdf
2014-03-19 00:00:00
19644 2 205433 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf
2014-12-03 00:00:00
19645 2 205434 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434Orig1s001lbledt.pdf
2015-10-15 00:00:00
19646 2 205434 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434s003lbl.pdf
2015-12-09 00:00:00
19647 2 205436 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl
.pdf 2015-03-09 00:00:00
19648 2 205437 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf
2015-12-28 00:00:00
19649 2 205474 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205474s000lbl.pdf
2014-11-20 00:00:00
19650 2 205476 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205476Orig1s000lbl.pdf
2016-04-11 00:00:00
19651 2 205488 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205488s001lbl.pdf
2015-05-13 00:00:00
19652 2 205490 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205490Orig1s000lbl.pdf
2015-10-22 00:00:00
19653 2 205494 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205494Orig1s000lbl.pdf
2014-08-22 00:00:00
19655 2 205551 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf
2014-08-26 00:00:00
19656 2 205551 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf
2015-08-07 00:00:00
19657 2 205552 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf
2016-07-18 00:00:00
19658 2 205572 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205572s000lbl.pdf
2015-04-10 00:00:00
19659 2 205572 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205572s002lbl.pdf
2016-07-26 00:00:00
19660 2 205582 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205582s000lbl.pdf
2014-01-28 00:00:00
19661 2 205583 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s000lbl.pdf
2014-01-31 00:00:00
19662 2 205583 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf
2014-07-23 00:00:00
19663 2 205596 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205596s000lbl.pdf
2014-03-19 00:00:00
19664 2 205596 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002
s004,0205596s001s003lbl.pdf 2015-11-19 00:00:00
19665 2 205596 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002
s004,0205596s001s003lbl.pdf 2015-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205609Orig1s000lbl.pdf
2016-07-18 00:00:00
19667 2 205613 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf
2014-10-09 00:00:00
19668 2 205625 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205625s000lbl.pdf
2014-08-22 00:00:00
19669 2 205636 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s004lbl.pdf
2016-04-29 00:00:00
19670 2 205637 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf
2014-06-10 00:00:00
19671 2 205641 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205641s000lbl.pdf
2014-05-12 00:00:00
19672 2 205692 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf 2020-
03-23 00:00:00
19673 14 205692 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19674 14 205692 SUPPL 5 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19675 2 205718 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf
2014-10-14 00:00:00
19676 2 205718 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf
2015-05-06 00:00:00
19677 2 205718 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf
2015-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf
2016-05-23 00:00:00
19679 2 205750 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205750lbl.pdf 2015-
03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205755s000lbl.pdf
2014-04-29 00:00:00
19681 2 205755 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf
2015-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205776s000lbl.pdf
2014-07-11 00:00:00
19683 2 205776 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205776s001lbl.pdf
2015-08-25 00:00:00
19684 2 205777 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf 2014-
07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205787Orig1s000lbl.pdf
2014-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205831s000lbl.pdf
2015-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205832s000lbl.pdf
2014-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205832s001lbl.pdf
2016-03-04 00:00:00
19689 2 205834 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf
2015-11-19 00:00:00
19690 2 205834 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf
2016-02-25 00:00:00
19691 2 205836 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836s001,205837s001,2058
38s001lbl.pdf 2016-06-06 00:00:00
19692 2 205837 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836Orig1s000,205837Orig
1s000,205838Orig1s000lbl.pdf 2016-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836Orig1s000,205837Orig
1s000,205838Orig1s000lbl.pdf 2016-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s000lbl.pdf
2014-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s001lbl.pdf
2014-11-20 00:00:00
19696 2 205874 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205874s004lbl.pdf
2015-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205883Orig1s000lbl.pdf
2016-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205901Orig1s000lbl.pdf
2016-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf
2014-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.pdf
2015-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf
2015-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s001lbl.pdf
2015-09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s003lbl.pdf
2015-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206088s000lbl.pdf
2014-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206099s000lbl.pdf
2016-02-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206143Orig1s000lbl.pdf
2015-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf 2014-
12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf
2015-11-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206197Orig1s000lbl.pdf
2016-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206263Orig1s000lbl.pdf
2016-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206276s000lbl.pdf
2015-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf
2014-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf
2014-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206317s000lbl.pdf
2015-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf
2015-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206334s000lbl.pdf
2014-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s000lbl.pdf
2015-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206369Orig1s000lbl.pdf
2015-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206439s003lbl.pdf
2016-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206448Orig1s000lbl.pdf
2015-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206500s000lbl.pdf
2015-09-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lbl.pdf 2014-
07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206552Orig1s000lbl.pdf
2016-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206581Orig1s000lbl.pdf
2015-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s005lbl.pdf
2015-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s006lbl.pdf
2015-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206628s000lbl.pdf
2015-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206679s000lbl.pdf
2016-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf
2015-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756s001lbl.pdf
2015-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s002lbl.pdf
2016-03-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf
2016-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206769s000lbl.pdf
2014-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206814lbl.pdf 2014-
12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843s000lbl.pdf
2015-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf
2016-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s004lbl.pdf
2016-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf
2015-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019845s020ltr.pdf
2007-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019845s021ltr.pdf
2008-05-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,1985
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,1985
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019847s032,019857s038l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,198
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019847s041ltr.pdf
2008-01-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s046,019857s053l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s050,019857s057l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s054ltr.pdf
2013-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,
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19878 1 019950 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,
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19879 1 019950 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,
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19881 1 019951 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019951s030ltr.pdf
2012-06-05 00:00:00
19882 1 019951 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019952s026ltr.pdf
2011-12-29 00:00:00
19884 1 019952 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019952Orig1s031ltr.pdf
2013-09-04 00:00:00
19885 1 019952 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019952Orig1s033ltr.pdf
2016-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019953s025ltr.pdf
2011-12-29 00:00:00
19887 1 019953 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s029ltr.pdf
2013-01-14 00:00:00
19888 1 019953 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s030ltr.pdf
2013-09-04 00:00:00
19889 1 019953 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019953Orig1s032ltr.pdf
2016-05-16 00:00:00
19890 1 019955 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,
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19892 1 019955 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf
2015-02-19 00:00:00
19894 1 019958 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019958s017ltr.pdf
2010-09-08 00:00:00
19895 14 019959 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19896 14 019959 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
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event=faq.page#nda_bla 2020-03-23 00:00:00
19897 14 019959 SUPPL 77 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19961slr009ltr.pdf
2003-09-29 00:00:00
19899 1 019962 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-
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19900 1 019962 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962s22ltr.pdf
2002-03-05 00:00:00
19901 1 019962 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s028ltr.pdf
2005-04-12 00:00:00
19902 1 019962 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s031LTR.pdf
2006-05-05 00:00:00
19903 1 019962 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s032LTR.pdf
2006-08-04 00:00:00
19904 1 019962 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s034ltr.pdf
2007-03-23 00:00:00
19905 1 019962 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019962s036ltr.pdf
2008-02-19 00:00:00
19906 1 019962 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s041ltr.pdf
2010-03-24 00:00:00
19907 1 019962 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s042ltr.pdf
2010-01-26 00:00:00
19908 1 019962 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019962Orig1s044ltr.pdf
2014-05-08 00:00:00
19909 1 019964 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19967slr004ltr.pdf
2003-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011l
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19913 1 019968 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19968s007ltr.pdf
2004-09-17 00:00:00
19914 1 019976 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19976slr005ltr.pdf
2002-11-04 00:00:00
19915 1 019977 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf
2001-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf
2002-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20186slr015,19982slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019982s014,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019982s016ltr.pdf
2011-02-10 00:00:00
19920 14 019991 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19921 14 019991 SUPPL 68 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19922 14 019991 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19923 14 019991 SUPPL 77 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
19924 1 019998 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019998s017ltr.pdf
2010-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020001Orig1s012ltr.pdf
2015-12-18 00:00:00
19926 1 020007 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr
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19927 1 020007 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016l
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19928 1 020007 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019l
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19929 1 020007 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605
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19930 1 020007 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020007Orig1s046ltr.pdf
2014-09-23 00:00:00
19931 1 020010 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020010s011LTR.pdf
2006-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020010s021ltr.pdf
2009-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037l
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19937 1 020011 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031S26ltr.pdf
2001-04-13 00:00:00
19941 1 020031 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031s29ltr.pdf
2001-12-14 00:00:00
19942 1 020031 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20031se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf
2004-04-20 00:00:00
19944 1 020031 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf
2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20031s045,20936s020ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021703s017,207026s002lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207071s000lbl.pdf
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2015-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf
2016-02-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207155s000lbl.pdf
2016-03-15 00:00:00
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2016-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207533s000lbl.pdf
2015-10-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207589s000lbl.pdf
2015-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207589s001lbl.pdf
2016-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207620Orig1s000lbl.pdf
2015-07-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207768lbl.pdf 2015-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf 2015-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207916s000lbl.pdf
2016-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207923lbl.pdf 2015-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207925s000lbl.pdf
2015-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207926s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207946s000lbl.pdf
2015-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2015/207947s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s
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2015-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208079lbl.pdf 2016-
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2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208143s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208261Orig1s000lbl.pdf
2016-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf 2003-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/018936Orig1s093.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018936Orig1s097.pdf
2015-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19557S023_VePesid.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-
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event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019653_s030_ORTHO
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19658-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019898s062.pdf 2012-
03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019918ap.pdf 1997-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019928Orig1s001.pdf
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/20246Orig1s052.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020305_s010_Kytril
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306s005Fludeoxyglucose.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020337s001_temovate_toc.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020430_toc.cfm 2010-
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01-28 00:00:00
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,20641s120704s3_Claritin-DTOC.cfml 2007-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020471_s009_Zyflo_Filmtab.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020472_s001_ESTRING 2
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020472_s004_ESTRING 2
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020482a_s007_s008.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-484_Innohep.cfm
2000-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020489_S007_ANDRODERM_AP.pdf
2007-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20491s001.cfm 1999-
05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s002_Corvert.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf 2001-
04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm 1999-
02-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20503-S004_Proventil.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020505s000_Topamax.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020505Orig1s018.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20508S005_Lac-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020509_S033_GEMZAR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020511ap.pdf 1997-
11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020517_S000_Lupron_Depot.PD
F 2006-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020517_s002ap.pdf 1997-
05-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020517_S006_Lupron
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Revie
w.pdf 2015-01-20 00:00:00
20696 3 020518 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20520s1_Zantac.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020520_S015_ZANTAC.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20521ltr.pdf
2020-03-23 00:00:00
20700 14 020522 SUPPL 9 This Former NDA Was Deemed To Be a BLA on
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20701 14 020522 SUPPL 11 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-524S005_Mentax.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20527S004_Prempro.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20527S013_Prempro.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527s017_prempro_toc.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s026_prempro.pdf
2011-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020527Orig1s046.pdf
2013-01-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538S6.cfm 1999-01-08
00:00:00
20709 3 020545 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020545_procanbid_toc.cfm
2003-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20545s007_Procanbid.cfm
2004-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-547-S007_Accolate.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20547-s008_accolate.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020550ap.pdf 1997-
09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555S003_AxidAr.cfm
2004-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20560ap_s03_s06.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s028_FOSAMAX
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-574_GyneLotrimin.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20582_FOLLISTIM%2075IU
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2015-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020587_sclerosol_toc.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588.pdf 1997-10-17
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020588_s004_RISPERDAL
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020592_Original_Approval_Pkg .
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020592_S006_ZUPREXA_ORAL_TAB
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020592_s034_Zyprexa
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/Zyprexa_20592s39_toc.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592_s40s41_zyprexa_toc.cf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020592Orig1s049.pdf
2012-01-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020596_S010_Epivir.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-564s012_20-
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2016-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020599Orig1s008.pdf
2016-02-02 00:00:00
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2015-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-
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2006-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020729_S010_UNIRETIC.pdf
2007-09-26 00:00:00
20886 3 020738 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020738_tevetan_toc.cfm
2011-05-06 00:00:00
20887 3 020740 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S002_Baycol.cfm
2001-11-29 00:00:00
20888 3 020740 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S003_Baycol.pdf
2001-11-29 00:00:00
20889 3 020740 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740s007.pdf 2007-
09-24 00:00:00
20890 3 020740 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S014_Baycol.pdf
2001-12-03 00:00:00
20891 3 020740 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020740_S016_BAYCOL_TABLETS.p
df 2008-02-19 00:00:00
20892 3 020741 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020741_S009_PRANDIN_TABS_AP.
pdf 2007-07-06 00:00:00
20893 3 020741 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S015_PRANDIN_TABS_AP.
pdf 2007-07-06 00:00:00
20894 14 020744 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020747Orig1s003.pdf
2012-02-28 00:00:00
20896 3 020747 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020747_S019_ACTIQ.pdf
2008-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020748_differin.cfm
2003-05-08 00:00:00
20898 3 020752 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20752s000_PecidTOC.cfm
2005-06-23 00:00:00
20899 3 020752 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 &
019527_S024 & 020752_S005_Pepcid RPD_AP.pdf 2007-07-09 00:00:00
20900 3 020753 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-753_Aromasin.cfm
2004-05-27 00:00:00
20901 3 020755 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020755_caverject_toc.cfm
2003-08-07 00:00:00
20902 3 020757 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s009_Avapro.PDF
2005-04-27 00:00:00
20903 3 020757 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s011_Avapro.PDF
2005-04-27 00:00:00
20904 3 020757 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s012_Avapro.PDF
2005-04-27 00:00:00
20905 3 020757 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757S014_Avapro.pdf
2004-05-27 00:00:00
20906 3 020757 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s017_Avapro.PDF
2005-04-27 00:00:00
20907 3 020757 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s019_Avapro.PDF
2005-04-27 00:00:00
20908 3 020757 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s020_Avapro.PDF
2005-04-27 00:00:00
20909 3 020757 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
757s023_Avapro_P1.PDF 2005-05-05 00:00:00
20910 3 020757 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s026_Avapro.PDF
2005-07-29 00:00:00
20911 3 020757 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF
2005-05-03 00:00:00
20912 3 020757 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s033_Avapro.PDF
2005-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020757_020758_toc.cfm
2009-09-01 00:00:00
20914 3 020758 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20758S003.cfm 1998-
08-31 00:00:00
20915 3 020758 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20758-s016_avalide.pdf
2004-05-27 00:00:00
20916 3 020758 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF
2005-05-03 00:00:00
20917 3 020758 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-758s031_Avalide.pdf
2005-04-27 00:00:00
20918 3 020762 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020762Orig1s050.pdf
2016-07-27 00:00:00
20919 3 020762 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020762Orig1s051.pdf
2016-07-27 00:00:00
20920 3 020763 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20763_Amerge.cfm 2004-
05-27 00:00:00
20921 3 020764 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020764a.cfm 1999-05-20
00:00:00
20922 3 020764 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020241s003.cfm 1999-
06-30 00:00:00
20923 3 020766 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020766_S013_XENICAL_CAPS_AP.
pdf 2007-07-06 00:00:00
20924 3 020766 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020766_S018_XENICAL_CAPSULES
_AP.pdf 2007-07-06 00:00:00
20925 3 020766 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020766_S021_XENICAL_CAPS_AP.
pdf 2007-07-06 00:00:00
20926 3 020768 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020768_toc.cfm 2010-
01-29 00:00:00
20927 3 020768 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020768_S010_ZOMIG_TABLETS.pd
f 2008-02-19 00:00:00
20928 3 020771 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020771_S004_DetrolTOC2.cfm
2007-06-11 00:00:00
20929 3 020771 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020771_s011_DELTROL 1
& 2 MG.pdf 2008-07-31 00:00:00
20930 14 020772 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20774.cfm 1998-05-15
00:00:00
20932 3 020776 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-776_Daypro.cfm
2005-04-27 00:00:00
20933 3 020778 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020778ap.pdf 1997-
03-14 00:00:00
20934 3 020778 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020778_S010_VIRACEPT.pdf
2007-08-06 00:00:00
20935 3 020778 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020778_S022_VIRACEPT.pdf
2007-08-06 00:00:00
20936 3 020779 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020779ap.pdf 1997-
03-14 00:00:00
20937 3 020779 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20778S11_viracept.cfm
2003-04-30 00:00:00
20938 3 020779 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020779_S026_VIRACEPT.pdf
2007-08-06 00:00:00
20939 3 020779 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S035_VIRACEPT.pdf
2007-08-06 00:00:00
20940 3 020779 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S036_VIRACEPT.pdf
2007-08-06 00:00:00
20941 3 020779 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020779_S045_VIRACEPT.pdf
2007-08-06 00:00:00
20942 3 020780 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020780_S003_Cipro.pdf
2008-08-08 00:00:00
20943 3 020780 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020780_S011_CIPRO.pdf
2008-08-01 00:00:00
20944 3 020780 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S012_CIPRO.pdf
2007-11-19 00:00:00
20945 3 020780 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S015_CIPRO.pdf
2007-11-19 00:00:00
20946 3 020780 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S017_CIPRO.pdf
2008-07-31 00:00:00
20947 3 020780 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S018_CIPRO.pdf
2008-07-31 00:00:00
20948 3 020780 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020780_S020_CIPRO.pdf
2007-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020781_S001_ZOFRAN.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020782_s000_DepakoteTOC.cfm
2006-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020785s000_ThalidomideTOC.cfm
2006-09-06 00:00:00
20952 3 020785 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S020_THALOMID.pdf
2007-07-27 00:00:00
20953 3 020785 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S021_THALOMID.pdf
2007-07-27 00:00:00
20954 3 020786 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s002_ALLEGRA
D.pdf 2008-08-08 00:00:00
20955 3 020786 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020786_S012_ALLEGRA
D.pdf 2007-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020788_propecia_toc.cfm
2003-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s017.pdf
2014-07-02 00:00:00
20958 3 020788 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s018.pdf
2014-01-16 00:00:00
20959 3 020788 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s020.pdf
2014-07-02 00:00:00
20960 3 020788 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s021.pdf
2014-07-02 00:00:00
20961 3 020788 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s023.pdf
2014-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020791_testoderm_toc.cfm
2003-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020792ap.pdf 1997-
10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020793_000_CafcitTOC.cfm
2005-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20796_Comtan.cfm 1999-
12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-799_Floxin.cfm 2005-
01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020800Orig1s023.pdf
2013-10-21 00:00:00
20968 3 020801 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020801Orig1s012.pdf
2012-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020811ap.pdf 1997-
11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020812_PediatricTOC.cfm
2005-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020812Orig1s011.pdf
2013-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20815s2_Evista.pdf
1998-11-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020816_azopt.cfm 2003-
06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20819_Zemplar.cfm 1998-
04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020822a.cfm 1998-07-17
00:00:00
20977 3 020822 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020822_s019_CelexaTOC.cfm
2006-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Or
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020822Orig1s042.pdf
2013-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20823_Exelon.cfm
2000-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020823_S003_EXELON_AP.pdf
2007-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020823_016_exelon.pdf
2006-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020825_s021_GEODON.pdf
2008-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020825Orig1s034.pdf
2012-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020828_S006_FORTOVASE.pdf
2007-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020828_S015_FORTOVASE.pdf
2007-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S025_SINGULAIR_TABLET
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20830_Singulair.cfm
2001-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830s008_Singulair.cfm
2001-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 &
020830_S026 & 021409_S005_SINGULAR_AP.pdf 2007-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-832_CHLORAPREP.cfm
2000-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020832_S008_CHLORAPREP_WITH_
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020834_rogaine_toc.cfm
2003-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm
2001-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm
2001-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S010_ACTENOL.pdf
2008-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S011_ACTONEL.pdf
2008-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S012_ACTONEL.pdf
2008-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20837_Xenopex.cfm 1999-
03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20838_Atacand.cfm 2003-
05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20838-s008_atacand.pdf
2004-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020839_s000.pdf
2010-03-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-002.PDF 2005-
08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-004.PDF
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-005.PDF
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-013.PDF
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-014.PDF
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-015.PDF
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-016.PDF
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-017.PDF
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020839_s034_plavix.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020841_Lotemax.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020844s000_Topamax.cfm
2004-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax.cfm
2000-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-505s002_20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20845_INOmax.cfm 1999-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020845Orig1s014.pdf
2016-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020845Orig1s017.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020846.pdf 1999-02-04
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020849_s000_Prosol.cfm
2005-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020855_mesnex.cfm
2003-05-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S009_Combivar.pdf
2007-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S010_Combivar.pdf
2007-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20859_Sonata.cfm 2000-
07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020862_Hectorol.cfm
1999-06-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20863.cfm 1999-01-15
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf
2004-04-15 00:00:00
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df 2008-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-006.pdf 2004-
04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-007.pdf 2004-
04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020868a.pdf 1997-11-26
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf
2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf
2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.
pdf 2008-08-01 00:00:00
21037 3 020872 SUPPL 9 0

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pdf 2008-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20873_Angiomax.cfm
2004-04-08 00:00:00
21039 3 020882 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20882.cfm 1998-10-09
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-883_Acova.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020885a.pdf 1998-10-09
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020885Orig1s004.pdf
2011-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20886.cfm 1999-02-02
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20887.cfm 1998-09-14
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20892.cfm 1998-09-25
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/NDA/98/viagra/viagra_toc.cfm
2009-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S002_VIAGRA.pdf
2008-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897.cfm 1998-12-16
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20900_Pylori-Chek.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20901.cfm 1999-07-08
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
903S006S007_Rebetol.pdf 2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
903s008s011s012s016_Rebetol.cfm 2005-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060,
020936s037, 020710s024ltr.pdf 2008-11-03 00:00:00
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020710s025ltr.pdf 2009-02-03 00:00:00
21056 1 020031 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,
020936s046ltr.pdf 2012-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020032s026ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020032s036ltr.pdf
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020033s033ltr.pdf 2007-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20036slr020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20036s24ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20076S11LTR.PDF
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r.pdf 2009-03-10 00:00:00
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r.pdf 2009-03-10 00:00:00
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r.pdf 2012-04-23 00:00:00
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r.pdf 2012-04-23 00:00:00
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Orig1s033ltr.pdf 2015-04-17 00:00:00
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ov.pdf 2004-07-01 00:00:00
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lbl.pdf 2004-06-09 00:00:00
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020101s034, 020974s007, 021235s006ltr.pdf 2006-04-13 00:00:00
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020101s036ltr.pdf 2007-03-23 00:00:00
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20101s37,21235s9,21520s1314ltr.pdf 2007-08-07 00:00:00
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020101s038, 021235s010ltr.pdf 2008-03-12 00:00:00
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021235s014ltr.pdf 2009-02-03 00:00:00
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020605s008rev2.pdf 2006-01-06 00:00:00
21163 1 020103 SUPPL 27 0

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020781s010ltr.pdf 2006-09-18 00:00:00
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020781s014ltr.pdf 2011-09-16 00:00:00
21165 1 020103 SUPPL 34 0

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Orig1s018,020781Orig1s018ltr.pdf 2014-09-23 00:00:00
21166 1 020105 SUPPL 2 0
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21180 1 020121 SUPPL 44 0

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2015-01-26 00:00:00
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f 2002-09-30 00:00:00
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021489s001ltr.pdf 2007-09-06 00:00:00
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tr.pdf 2010-12-22 00:00:00
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022ltr.pdf 2010-08-16 00:00:00
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022ltr.pdf 2010-08-16 00:00:00
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Orig1s025ltr.pdf 2013-11-27 00:00:00
21200 1 020136 SUPPL 23 0

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2010-02-01 00:00:00
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002LTR.pdf 2002-06-20 00:00:00
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2014-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20147S06LTR.PDF
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699slr041,048,052ltr.pdf 2004-05-26 00:00:00
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.pdf 2005-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020151s052ltr.pdf
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lr030,031,20156slr031032ltr.pdf 2002-09-25 00:00:00
21223 1 020154 SUPPL 44 0

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020155s039, 020156s040, 021183s016ltr.pdf 2006-12-28 00:00:00
21226 1 020155 SUPPL 21 0

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1999-10-29 00:00:00
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lr030,031,20156slr031032ltr.pdf 2002-09-25 00:00:00
21228 1 020155 SUPPL 32 0

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21235 1 020163 SUPPL 20 0

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2014-05-01 00:00:00
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2016-05-06 00:00:00
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0ltr.pdf 2003-12-02 00:00:00
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2015-11-24 00:00:00
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2003-09-25 00:00:00
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2010-03-29 00:00:00
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ltr.pdf 2011-06-17 00:00:00
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r.pdf 2012-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042lt
r.pdf 2012-04-12 00:00:00
21265 3 020903 SUPPL 16 0
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903s008s011s012s016_Rebetol.cfm 2005-04-15 00:00:00
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RETETRON.pdf 2008-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020905_S007_ARAVA.pdf
2007-11-19 00:00:00
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12-08 00:00:00
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12-08 00:00:00
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s004_aggrasat.pdf 2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-922_Solage.cfm 2002-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020926.cfm 1999-07-04
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-929_Pulmicort.cfm
2004-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020929_S013_PULMICORT_RESPUL
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20932.cfm 1998-10-26
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020933_S014_VIRAMUNE.pdf
2007-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20934.cfm 1999-06-16
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020936Orig1s001.pdf
2011-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s004.pdf
2011-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s006.pdf
2011-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s007.pdf
2011-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020936_S012_PAXIL_AP.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-938_Mobic.cfm
2001-07-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-939_Diltiazem.cfm
2000-01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-941_Abreva.cfm
2001-08-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-943_VerelanPM.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil.cfm 2004-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf
2013-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947_pennsaid_toc.cfm
2010-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb.cfm
2001-03-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020951A_Tagament.cfm
2000-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20954.cfm 1999-06-14
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020955_S001_FERRLECIT_AP.pdf
2007-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20961_Vitravene.cfm
1998-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-965_Levulan.cfm
1999-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20969.cfm 1999-02-25
00:00:00
21308 3 020971 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020971_SeptocaineTOC.cfm
2002-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020971Orig1s013.pdf
2013-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020971Orig1s021.pdf
2015-01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/2010/020971Orig1s023.pdf 2015-
01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20972.cfm 1998-09-17
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
972_S001_Sustiva.cfm 2004-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020972_S027_SUSTIVA.pdf
2007-07-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20973_Aciphex.cfm 1999-
08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020973Orig1s009.pdf
2012-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm
2003-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20974_Prozac.cfm 1999-
03-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm
1999-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-
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21321 3 020977 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020977_S012_Ziagen.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-977_Ziagen.cfm 1998-
12-17 00:00:00
21323 3 020978 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020978_S009_ZIAGEN.pdf
2007-09-26 00:00:00
21324 3 020978 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020978_S016_ZIAGEN.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981_hycamtin_toc.cfm
2009-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-983_Ventolin-
HFA.cfm 2001-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20984_Raplon.cfm 2001-
07-02 00:00:00
21328 3 020986 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-986_NovoLog.cfm
2020-03-23 00:00:00
21329 14 020986 SUPPL 3 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
21330 14 020986 SUPPL 61 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20990_Zoloft.cfm 1999-
12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S35_Zoloft.cfm
2001-08-17 00:00:00
21334 3 020990 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019839s044,020990s010_Zoloft
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20992.cfm 1999-03-24
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020992_S016_CENESTINTOC.cfm
2007-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20997_Chirocaine.cfm
1999-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020998_S001_CELEBREX.pdf
2007-07-18 00:00:00
21339 3 020998 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S004_CELEBREX.pdf
2007-07-18 00:00:00
21340 3 020998 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21156-S007_Celebrex.cfm
2004-05-28 00:00:00
21341 3 020998 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S008_CELEBREX.pdf
2007-07-18 00:00:00
21342 3 020998 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
998s010_Celebrex.cfm 2005-02-02 00:00:00
21343 3 020998 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-
998s013_Celebrex.cfm 2005-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020998_S014_CELEBREXTOC.cfm
2009-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020998_s016_CelebrexTOC.cfm
2006-05-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir.cfm 1998-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21005_Solaraze.cfm
2003-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova.cfm
2001-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021008.cfm 1998-11-25
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-015_AndroGel.cfm
2004-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s008_AndrogelTOC.cfm
2006-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s010_AndrogelTOC.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019a.cfm 1999-10-06
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021024Orig1s008.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021025_s008_exelon_capsules.
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21027_Hectorol.cfm
2000-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021027Orig1s015.pdf
2012-05-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21036.cfm 1999-07-26
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-036-
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2014-01-16 00:00:00
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2013-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021038Orig1s020.pdf
2015-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21007&21039_Agenerase.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021040_s000_OrthoPrefestTOC.cf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-041_DepoCyt.cfm
2002-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021042_S004_VIOXX.pdf
2008-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021042_S011_VIOXX.pdf
2008-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S015_VIOXX.pdf
2008-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S016_VIOXX.pdf
2008-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s017_021052_s011_Viox
xTOC.cfm 2006-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s023_VioxxtmTOC.cfm
2006-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s024_021052_s017_Viox
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S026_VIOXX.pdf
2008-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S028_VIOXX.pdf
2008-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021045s11_planb.cfm
2006-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-046_Celexa.pdf 1999-
12-22 00:00:00
21389 3 021046 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Or
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm
2004-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021052_S010_VIOXX.pdf
2008-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s
014s015s016_VioxxTOC.cfm 2006-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021052_S021_VIOXX.pdf
2008-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-056_Targretin.cfm
2001-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21057_Antagon.cfm 2004-
05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-060_Prialt.cfm
2005-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011TOC.cfm
2012-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-066_Zaditor.cfm
1999-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021066Orig1s001.pdf
2011-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21071_Avandia.cfm 2004-
05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia.cfm
2004-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021071_S004_AVANDIA.pdf
2007-07-27 00:00:00
21407 3 021073 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S002_ACTOS.pdf
2007-09-13 00:00:00
21408 3 021073 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S004_ACTOS.pdf
2008-02-19 00:00:00
21409 3 021073 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S005_ACTOS.pdf
2007-09-13 00:00:00
21410 3 021073 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S006_ACTOS.pdf
2008-02-19 00:00:00
21411 3 021073 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S007_ACTOS.pdf
2008-02-19 00:00:00
21412 3 021073 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S008_ACTOS
TABLETS.pdf 2007-07-27 00:00:00
21413 3 021073 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S010_Actos
Tablets_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00
21414 3 021073 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S013_ACTOS_TABLETS.pd
f 2008-02-19 00:00:00
21415 3 021073 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S014_ACTOS.pdf
2007-11-19 00:00:00
21416 3 021073 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S016_ACTOS.pdf
2007-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard.cfm
2004-05-27 00:00:00
21419 3 021077 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21077_AdvairDiskus.cfm
2003-08-28 00:00:00
21420 3 021077 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_s019_ADVAIR
DISKUS.pdf 2008-08-01 00:00:00
21421 3 021077 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021077Orig1s050.pdf
2013-08-06 00:00:00
21422 3 021078 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021078_malarone.cfm
2003-06-16 00:00:00
21423 3 021078 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s001_MalaroneTOC.cfm
2006-07-10 00:00:00
21424 3 021078 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s004_MalaroneTOC.cfm
2006-07-10 00:00:00
21425 3 021079 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21079_Alamast.pdf 2004-
05-26 00:00:00
21426 14 021081 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
21427 3 021082 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-082_Tavist.cfm
2002-08-08 00:00:00
21428 3 021083 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21083A.cfm 1999-09-15
00:00:00
21429 3 021083 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021083_S006_RAPAMUNE.pdf
2009-09-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21084_SERPACWA.cfm
2001-10-11 00:00:00
21431 3 021085 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S10_Avelox.cfm
2004-05-27 00:00:00
21432 3 021085 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021085_S022_Avelox_Tablets.p
df 2008-02-19 00:00:00
21433 3 021086 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
086_ZyprexaZydis.cfm 2000-04-06 00:00:00
21434 3 021087 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S001_TamifluTOC.cfm
2007-06-18 00:00:00
21435 3 021087 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-087SE1-
002_review.pdf 2004-04-14 00:00:00
21436 3 021087 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S003_TamifluTOC.cfm
2007-06-18 00:00:00
21437 3 021087 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S004_TamifluTOC.cfm
2007-06-18 00:00:00
21438 3 021087 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_T
amifluTOC.cfm 2007-06-22 00:00:00
21439 3 021087 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004Tamifl
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21440 3 021087 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_Tamif
luTOC.cfm 2007-06-22 00:00:00
21441 3 021087 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S011_TamilfluTOC.cfm
2007-06-22 00:00:00
21442 3 021087 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021087Orig1s040.pdf
2013-06-03 00:00:00
21443 3 021087 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021087Orig1s056.pdf
2013-06-03 00:00:00
21444 3 021087 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s
062_tamiflu_toc.cfm 2013-04-08 00:00:00
21445 3 021088 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/02-1088_Vidaur.cfm
2000-03-03 00:00:00
21446 3 021093 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-093_AtacandHCT.cfm
2004-05-27 00:00:00
21447 3 021097 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021097Orig1s014.pdf
2011-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin.cfm
2001-05-11 00:00:00
21449 3 021098 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021098Orig1s022.pdf
2016-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021102_s000_21065_FemhrtTOC.cf
m 2006-01-03 00:00:00
21451 3 021103 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-103_Activella.cfm
2007-11-06 00:00:00
21452 14 021106 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21107a_Lotronex.cfm
2000-08-29 00:00:00
21454 3 021107 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S002_LOTRONEX_TABLET.
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S005_LOTRONEX_TABLETS
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21456 3 021107 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S006_LOTRONEX_TABLETS
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune.cfm
2001-10-11 00:00:00
21458 3 021116 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-116_Thyro-Tabs.cfm
2004-08-10 00:00:00
21459 3 021119 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
119S001_Visudyne.cfm 2001-08-22 00:00:00
21460 3 021120 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21120_Novantrone.cfm
2004-04-12 00:00:00
21461 3 021121 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-121_Concerta.cfm
2000-08-01 00:00:00
21462 3 021121 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021121s017.pdf 2011-
09-22 00:00:00
21463 3 021128 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
128_ChildrensMotrin.cfm 2004-03-10 00:00:00
21464 3 021129 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-129_Neurontin.cfm
2004-05-06 00:00:00
21465 3 021131 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm 2000-
04-18 00:00:00
21466 3 021131 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021131Orig1s012.pdf
2014-07-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
130s003_21131s003_21132s003_ZyvoxTOC.cfm 2005-07-11 00:00:00
21468 3 021134 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat.cfm
2000-05-01 00:00:00
21469 3 021135 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21135_Venofer.cfm
2004-06-29 00:00:00
21470 3 021140 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium.cfm
2000-01-29 00:00:00
21471 3 021140 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021140_S003_IMODIUM_ADVANCED
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-142_Olux.cfm 2004-
03-28 00:00:00
21473 3 021144 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021144Orig1s012Approv.pdf
2012-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21145_Vaniga.cfm
2003-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021145_S003_VANIQA
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine.cfm
2004-05-27 00:00:00
21477 14 021148 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021150s007TOC.cfm
2008-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021152s000TOC.cfm
2007-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s045.pdf
2014-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s047.pdf
2014-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21156-S007_Celebrex.cfm
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-163_Multi-12.cfm
2004-03-28 00:00:00
21484 3 021167 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-
323S23_Vivelle.cfm 2004-04-13 00:00:00
21485 3 021168 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-168_Depakote.cfm
2003-12-15 00:00:00
21486 3 021168 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021168_S004_DepakoteTOC.cfm
2006-07-10 00:00:00
21487 3 021168 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021168_S007_DepakoteTOC.cfm
2006-07-10 00:00:00
21488 2 021172 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_prntlbl.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-178_Glucovance.cfm
2003-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
178S004_Glucovance.cfm 2003-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_ORTHO.cfm
2001-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s001_ORTHO
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s003_OrthoTOC.cfm
2006-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-183_Videx.cfm
2004-03-11 00:00:00
21496 3 021183 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021183_S001_VIDEX_AP.pdf
2007-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-184s002_Avage.cfm
2004-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm
2015-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-190_Buspar.cfm
2004-03-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-191_Imagent.cfm
2002-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021192_s004_LESCOL_CAPSULES.
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021192s019.pdf 2012-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-196_Xyrem.cfm
2002-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-197_Cetrotide.cfm
2000-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-204_Stsrlix.cfm
2002-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021208_remeron.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021210_s002_Unithroid.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021210_S003_Unithroid.pdf
2005-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021210_s006_unithroid
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-212_Caverject.cfm
2002-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21214_Rescula.cfm
2004-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s006.pdf
2015-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s007.pdf
2015-11-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-222_Spectracef.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-223_Zometa.cfm
2001-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-224_Reminyl.cfm
2002-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-225_Mirena.cfm
2004-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021225Orig1s031.pdf
2016-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-226_Kaletra.cfm
2000-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra.cfm
2001-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021226_S006_KALETRA.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021226_S017_KALETRA.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021227_S014_CANCIDAS.pdf
2008-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-228_Detrol.cfm
2004-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021228_S002_DetrolTOC.cfm
2007-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-231_Zomig.cfm
2004-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021231_S003_ZOMIG_TABLETS.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-232_Orfadin.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-235_Prozac.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021235Orig1s016.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-238_Kytril.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21243_Azulfidine.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-246_Tamiflu.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_T
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2014-07-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021246Orig1s027.pdf
2013-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s035.pdf
2015-07-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021246Orig1s039.pdf
2013-06-03 00:00:00
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2000-09-15 00:00:00
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2004-08-09 00:00:00
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2001-02-21 00:00:00
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2002-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-292_Novothyrox.cfm
2004-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-301_Levoxyl.cfm
2002-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021301_s028_levoxyl
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021303_S001_AdderallTOC.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21304_Valcyte.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257_021304s007_valcyte_va
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021305_sodiumiodide.cfm
2003-06-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-307_Lotrimin.cfm
2002-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-308_Monistat.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021308_S009_MONISTAT
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21310.pdf 2005-07-15
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021312_s007_clarinex
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021314s000_IDKitTOC.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_altocor.cfm
2003-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm
2004-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm
2001-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXA
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort.cfm
2001-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-330_Commit.cfm
2004-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S10_Avelox.cfm
2004-05-27 00:00:00
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2001-11-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-343_Eligard.cfm
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2005-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread.cfm
2001-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021357_021358_Multihance.cfm
2005-03-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021358s000_021357s000_MultiH
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359_rectiv_toc.cfm
2012-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021360_S014_SUSTIVA.pdf
2007-07-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXA
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXA
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor.cfm
2004-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021366s024.pdf 2012-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021367TOC.cfm 2003-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021368Orig1s020.pdf
2014-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-371_Estrasorb.cfm
2005-01-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-372_Alox.cfm 2004-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm
2009-12-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021378s000_CombunoxTOC.cfm
2005-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-387_Pravagard.cfm
2004-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-392_CardizemTOC.cfm
2005-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021392_S002_CARDIZEM_LA_EXEN
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021393,021394_AdvilTOC.cfm
2006-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm
2004-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-396_Prempro.cfm
2005-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397_21-423_21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021399_iressa.cfm
2003-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-400_Levitra.cfm
2003-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021406s000TOC.cfm
2007-05-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-409_Singulair.cfm
2004-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 &
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021409_S007_SINGULAIR_TABLET
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021411_S001_STRATTERA_CAPSUL
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21643 3 021415 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021415s000_MetvixiaTOC.cfm
2006-03-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-417_Premarin.cfm
2003-09-25 00:00:00
21645 3 021425 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021425_ultravist.cfm
2003-06-26 00:00:00
21646 14 021426 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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21647 14 021426 SUPPL 4 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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21648 14 021426 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021427Orig1s039.pdf
2012-05-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021428_S004_PREVACID
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021433s000_FloventHFATOC.cfm
2005-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021436_S001_ABILIFY_TABLETS.
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021436Orig1s002.pdf
2013-05-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021436Orig1s007.pdf
2013-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018TOC.cfm
2009-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021436Orig1s038.pdf
2016-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021436Orig1s040.pdf
2016-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-437s002_Inspra.cfm
2004-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588O
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21445_Zetia.cfm 2003-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_LyricaTOC.cfm
2005-07-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028_lyrica_toc.c
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-447_Zanaflex.cfm
2004-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-449_Hepsera.cfm
2004-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-450_Zomig.cfm
2005-04-15 00:00:00
21670 3 021453 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021453_s000_ZeritTOC.cfm
2006-06-08 00:00:00
21671 3 021456 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm
2003-04-25 00:00:00
21672 3 021457 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021457s000TOC.cfm
2007-04-30 00:00:00
21673 3 021463 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463_fortesta_toc.cfm
2011-09-16 00:00:00
21674 3 021468 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-468_Fosrenol.cfm
2005-01-28 00:00:00
21675 3 021468 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s004_fosrenol.pdf
2011-01-04 00:00:00
21676 3 021470 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea.cfm
2004-03-24 00:00:00
21677 3 021471 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021471s000TOC.cfm
2008-07-09 00:00:00
21678 3 021473 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S005_CIPRO.pdf
2007-07-09 00:00:00
21679 3 021473 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S006_CIPRO.pdf
2007-07-09 00:00:00
21680 3 021473 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S007_CIPRO.pdf
2007-07-09 00:00:00
21681 3 021473 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S009_CIPRO.pdf
2007-07-09 00:00:00
21682 3 021475 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021475s000_MethylinTOC.cfm
2006-07-25 00:00:00
21683 3 021478 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021478_S003_Zovirax_APPROVAL
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21684 3 021479 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021479_zelapar_toc.cfm
2009-01-15 00:00:00
21685 14 021484 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
21686 3 021485 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_Stalevo.cfm
2004-03-24 00:00:00
21687 3 021486 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021486s000TOC.cfm
2007-06-04 00:00:00
21688 3 021488 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021488_eligard.cfm
2003-05-08 00:00:00
21689 3 021489 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021489s000_ProhanceTOC.cfm
2006-07-25 00:00:00
21690 3 021490 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-
490_NorethinOvcon.cfm 2005-02-02 00:00:00
21691 3 021492 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-492_Eloxatin.cfm
2002-08-09 00:00:00
21692 3 021492 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021492_s002_EloxatinTOC.cfm
2006-03-24 00:00:00
21693 3 021494 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021494s000_AxidTOC.cfm
2006-09-27 00:00:00
21694 3 021496 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21496_Duocaine.cfm
2003-11-06 00:00:00
21695 3 021498 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-498_Alinia.cfm
2003-04-25 00:00:00
21696 3 021498 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-
498s001_Alinia.cfm 2004-10-08 00:00:00
21697 3 021498 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021818s000_021498s003TOC.cfm
2007-10-02 00:00:00
21698 3 021501 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021501_capital_soleil_toc.cf
m 2009-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021502s001lbl.pdf
2006-12-26 00:00:00
21700 3 021503 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021503s000_ViraceptTOC.cfm
2005-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021503_S001_VIRACEPT.pdf
2007-08-06 00:00:00
21702 3 021503 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021503_S006_VIRACEPT.pdf
2007-08-06 00:00:00
21703 3 021504 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021504s000_LidositeTOC.cfm
2006-10-23 00:00:00
21704 3 021505 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/0221505_s000_Keppra.cfm
2004-11-01 00:00:00
21705 3 021506 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-506_Mycamine.cfm
2005-08-24 00:00:00
21706 3 021511 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-511_Copegus.cfm
2004-08-10 00:00:00
21707 3 021513 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-513_Enablex.cfm
2005-02-08 00:00:00
21708 3 021514 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021514_daytrana_toc.cfm
2008-11-14 00:00:00
21709 3 021515 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s03
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21710 3 021516 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021516s000_IstalolTOC.cfm
2006-01-31 00:00:00
21711 3 021519 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519_luvox_toc.cfm
2008-11-10 00:00:00
21712 3 021520 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021520Orig1s012.pdf
2013-05-10 00:00:00
21713 3 021524 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021524s000TOC.cfm
2007-07-18 00:00:00
21714 3 021525 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020415s012_021525_PhotofrinT
OC.cfm 2006-07-25 00:00:00
21715 3 021526 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa.cfm
2006-04-06 00:00:00
21716 3 021526 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021526Orig1s004TOC.cfm
2015-01-16 00:00:00
21717 3 021526 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021526Orig1s007.pdf
2014-08-05 00:00:00
21718 3 021527 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021527s000TOC.cfm
2007-01-23 00:00:00
21719 3 021530 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021530s000_MobicTOC.cfm
2006-03-21 00:00:00
21720 3 021532 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021532_benicar_toc.cfm
2003-09-10 00:00:00
21721 3 021535 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-535_Clobex.cfm
2004-06-14 00:00:00
21722 2 021536 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021536lbl.pdf 2020-
03-23 00:00:00
21723 14 021536 SUPPL 15 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
21724 14 021536 SUPPL 33 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
21725 3 021537 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021537Orig1s008.pdf
2015-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021540S000_Caduet.cfm
2004-08-05 00:00:00
21727 3 021544 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-544_Seasonale.cfm
2004-03-24 00:00:00
21728 3 021545 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021545s000TOC.cfm
2007-02-20 00:00:00
21729 3 021548 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-548_Lexiva.cfm
2004-10-26 00:00:00
21730 3 021549 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021549_S002_EMEND.pdf
2007-11-19 00:00:00
21731 3 021549 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021549Orig1S008.pdf
2012-03-02 00:00:00
21732 3 021554 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021554s000_CirpoXRTOC.cfm
2005-12-01 00:00:00
21734 3 021560 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000_zortress_toc.cfm
2010-06-16 00:00:00
21735 3 021563 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021563s000_ClarinexTOC.cfm
2006-07-10 00:00:00
21736 3 021567 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021567Orig1s019.pdf
2014-08-05 00:00:00
21737 3 021567 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s
035TOC.cfm 2015-04-07 00:00:00
21738 3 021569 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021569s000TOC.cfm
2007-09-11 00:00:00
21739 3 021571 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/NDA21-271_Iquix.cfm
2004-10-26 00:00:00
21740 3 021572 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-572_Cubicin.cfm
2003-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-575_Fosamax.cfm
2005-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_S042 &
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21744 3 021585 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021585s000_MucinexTOC.cfm
2005-12-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021586s000TOC.cfm
2008-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-587_Advil.cfm
2005-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021588_s005_GLEVAC.pdf
2015-05-26 00:00:00
21748 3 021588 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s011_gleevec.pdf
2006-10-19 00:00:00
21749 3 021588 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s017_gleevec.pdf
2006-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021589s000_KemstroTOC.cfm
2006-07-25 00:00:00
21751 3 021590 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021590s000_FazacloTOC.cfm
2005-10-06 00:00:00
21752 3 021592 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021592_foradil_certihaler_to
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-594_Amiodarone.cfm
2004-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021602_s010_velcade.pdf
2011-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021602Orig1s015.pdf
2011-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021604s000_Childrens_ElixSur
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021606s000TOC.cfm
2007-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-621_Zyrtec.cfm
2004-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.cfm
2008-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021624Orig1s001.pdf
2013-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21625s000_MVI_AdultTOC.cfm
2006-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021632_021948_EraxisTOC.cfm
2006-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021641s000_AzilectTOC.cfm
2006-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021648s000TOC.cfm
2007-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21660_AbraxaneTOC.cfm
2005-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021660Orig1s022.pdf
2012-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-663_MenopurTOC.cfm
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21669s000TOC.cfm
2007-01-22 00:00:00
21773 3 021669 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021669_s006_chlorhexidine
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-670_VisionBlue.cfm
2005-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-673_Clolar.cfm
2005-04-05 00:00:00
21776 3 021674 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021674_s000_MenostarTOC.cfm
2006-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin.cfm
2004-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm
2004-05-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021693s000TOC.cfm
2007-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021695s000_AntaraTOC.cfm
2006-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021698s000TOC.cfm
2007-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021710s000_EquetroTOC.cfm
2006-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021711s000TOC.cfm
2009-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021712s000_TOC.cfm
2007-03-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pd
f 2012-01-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021720_s000_AriceptTOC.cfm
2006-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021721s000TOC.cfm
2007-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061,
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf
2012-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021723s000_LyricaCapsTOC.cfm
2005-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021724s000TOC.cfm
2008-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021729Orig1s006_s007_s009.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021730s000TOC.cfm
2006-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021731s000_EligardTOC.cfm
2006-09-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021732s000_VantasTOC.cfm
2006-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021733s000_CymbaltaTOC.cfm
2005-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021735s000_TerconazoleTOC.cf
m 2006-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021745_ryzolt_toc.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075491_bupropion_toc.cfm
2003-07-30 00:00:00
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2000-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75523_Pentazocine_Naloxone.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226ppi.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251ppi.pdf 2000-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324PPIlbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829ppi.pdf 2007-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM349707.pdf2013-04-26
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM266314.pdf2011-08-02
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf2016-05-18
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http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088574.pdf2009-11-16
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188475.pdf2009-10-30
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf2012-06-29
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206668.pdf2010-03-31
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180714.pdf2020-03-23
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf
2013-07-12 00:00:00
23459 8 125277 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277MedGuide.pdf
2009-12-02 00:00:00
23462 8 125293 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227568.pdf2010-09-30
00:00:00
23469 8 125521 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM493178.pdf2016-03-30
00:00:00
23470 8 125544 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM497384.pdf2016-04-27
00:00:00
23473 8 200677 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM332633.pdf2012-12-18
00:00:00
23474 8 200678 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280360.pdf2013-06-12
00:00:00
23481 8 201917 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf2011-05-23
00:00:00
23486 8 202258 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255471.pdf2011-05-17
00:00:00
23491 8 202317 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM366908.pdf2013-08-30
00:00:00
23492 8 202343 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM275945.pdf2011-10-07
00:00:00
23496 8 202799 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf2012-03-27
00:00:00
23497 8 202810 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf
2012-10-22 00:00:00
23500 8 203441 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333533.pdf2013-01-03
00:00:00
23503 8 203568 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf2013-02-05
00:00:00
23505 8 203595 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337734.pdf2013-02-05
00:00:00
23515 8 204592 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372061.pdf2013-10-24
00:00:00
23518 8 204886 SUPPL 2 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447698.pdf2015-05-27
00:00:00
23519 8 205353 ORIG 1 0
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf2015-03-03
00:00:00
23527 10 007392 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2007-03-16 00:00:00
23528 10 010187 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm
2007-05-10 00:00:00
23529 10 010402 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103324.htm 2009-06-02 00:00:00
23530 10 011909 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23531 10 014715 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23532 10 016798 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23533 10 016832 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm126461.htm 2011-12-20 00:00:00
23534 10 016949 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23535 10 017090 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23536 10 017116 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142827.htm 2006-11-27 00:00:00
23537 10 017831 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23538 10 017892 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2007-03-16 00:00:00
23539 10 018013 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23540 10 018081 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm192645.htm 2008-02-01 00:00:00
23541 10 018207 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23542 10 018708 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2007-03-16 00:00:00
23543 10 018723 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm192645.htm 2008-02-01 00:00:00
23544 10 018936 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23545 10 018938 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107924.htm 2007-12-04 00:00:00
23546 10 019010 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23547 10 019084 ORIG 1 0
http://www.fda.gov/drugs/drugsafety/ucm362415.htm 2014-02-07 00:00:00
23548 10 019297 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm126445.htm 2008-07-29 00:00:00
23549 10 019627 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109357.htm 2007-06-18 00:00:00
23550 10 019680 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm192645.htm 2008-02-01 00:00:00
23551 10 019726 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23552 10 019732 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23553 10 019758 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23554 10 019777 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2006-06-09 00:00:00
23555 10 019794 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm192645.htm 2011-12-20 00:00:00
23556 10 019810 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23557 10 019813 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm114961.htm 2005-07-29 00:00:00
23558 10 019839 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm05
3351.htm 2005-07-29 00:00:00
23559 10 019906 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23560 10 019908 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2007-03-16 00:00:00
23561 10 019915 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2006-06-09 00:00:00
23562 10 019927 ORIG 1 0
http://www.fda.gov/drugs/drugsafety/ucm362415.htm 2014-02-07 00:00:00
23563 10 019955 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107924.htm 2007-12-04 00:00:00
23564 10 020036 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23565 10 020059 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm234178.htm 2013-12-27 00:00:00
23566 10 020103 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm271924.htm 2011-12-20 00:00:00
23567 10 020123 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142882.htm 2006-06-09 00:00:00
23568 10 020132 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101549.htm 2007-01-17 00:00:00
23569 10 020151 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm106481.htm 2005-04-15 00:00:00
23570 10 020154 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm201885.htm 2010-08-09 00:00:00
23571 10 020184 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2006-06-09 00:00:00
23572 10 020204 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103420.htm 2005-07-28 00:00:00
23574 10 020310 ORIG 1 0
http://www.fda.gov/drugs/drugsafety/ucm362415.htm 2014-02-07 00:00:00
23575 10 020312 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2006-06-09 00:00:00
23576 10 020313 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm388640.htm 2014-03-12 00:00:00
23577 10 020355 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107924.htm 2007-12-04 00:00:00
23578 10 020358 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23579 10 020377 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-29 00:00:00
23580 10 020406 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23581 10 020517 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23582 10 020527 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103324.htm 2009-06-02 00:00:00
23583 10 020528 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2006-06-09 00:00:00
23584 10 020578 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23585 10 020588 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-20 00:00:00
23586 10 020626 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101549.htm 2007-01-17 00:00:00
23587 10 020639 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23588 10 020648 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm115425.htm 2006-03-31 00:00:00
23589 10 020665 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm
2011-12-22 00:00:00
23590 10 020687 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111323.htm 2006-10-12 00:00:00
23591 10 020692 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm108111.htm 2005-11-30 00:00:00
23592 10 020699 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm106481.htm 2005-04-15 00:00:00
23593 10 020707 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23594 10 020711 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23595 10 020715 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23596 10 020733 ORIG 1 0
http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm 2006-
10-11 00:00:00
23597 10 020763 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101549.htm 2003-12-08 00:00:00
23598 10 020768 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101549.htm 2007-01-17 00:00:00
23599 10 020788 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm
2011-12-20 00:00:00
23600 10 020818 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm
2011-12-22 00:00:00
23601 10 020829 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm 2008-08-12
00:00:00
23602 10 020830 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm 2008-08-12
00:00:00
23603 10 020831 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm108111.htm 2003-12-09 00:00:00
23604 10 020835 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2009-04-24 00:00:00
23605 10 020839 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm190836.htm 2010-08-09 00:00:00
23606 10 020859 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103285.htm 2003-12-12 00:00:00
23607 10 020885 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm162833.htm 2007-10-30 00:00:00
23609 10 020899 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110260.htm 2008-07-11 00:00:00
23610 10 020919 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23611 10 020936 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142882.htm 2006-06-09 00:00:00
23613 10 020978 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094302.htm 2003-12-12 00:00:00
23614 10 020987 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23615 10 020988 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23616 10 020990 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101549.htm 2003-12-08 00:00:00
23618 10 021035 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2007-03-28 00:00:00
23619 10 021044 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm129288.htm 2005-04-15 00:00:00
23620 10 021052 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103420.htm 2004-09-30 00:00:00
23621 10 021064 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110260.htm 2003-11-20 00:00:00
23622 10 021076 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103420.htm 2005-07-28 00:00:00
23623 10 021077 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm108111.htm 2005-11-30 00:00:00
23624 1 021081 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21081ltr.pdf
2020-03-23 00:00:00
23625 10 021098 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm257168.htm 2011-11-16 00:00:00
23626 10 021113 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23627 10 021120 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm126445.htm 2008-07-29 00:00:00
23628 10 021144 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107824.htm 2004-07-13 00:00:00
23629 10 021156 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103420.htm 2003-12-09 00:00:00
23630 10 021162 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm
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23631 10 021168 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm192645.htm 2008-02-01 00:00:00
23632 10 021169 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109350.htm 2005-07-29 00:00:00
23633 10 021208 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109344.htm 2005-08-01 00:00:00
23634 10 021223 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2003-12-12 00:00:00
23635 10 021224 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109350.htm 2005-07-29 00:00:00
23636 10 021229 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2003-06-20 00:00:00
23637 10 021231 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101549.htm 2007-01-17 00:00:00
23638 10 021253 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23639 10 021254 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23640 10 021268 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm
2011-12-22 00:00:00
23641 10 021284 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm
2007-05-10 00:00:00
23642 10 021299 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23643 10 021303 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111441.htm 2005-04-15 00:00:00
23644 10 021323 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm05
3342.htm 2005-07-29 00:00:00
23645 10 021336 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23646 10 021341 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103420.htm 2003-12-09 00:00:00
23647 10 021343 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23648 10 021346 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-20 00:00:00
23649 10 021357 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142882.htm 2006-06-09 00:00:00
23650 10 021365 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109095.htm 2004-03-24 00:00:00
23652 10 021379 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23653 10 021395 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107272.htm 2004-07-13 00:00:00
23654 10 021409 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm 2008-08-12
00:00:00
23655 10 021410 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm143349.htm 2008-02-21 00:00:00
23656 10 021411 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107912.htm 2005-09-30 00:00:00
23657 10 021419 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm
2011-12-20 00:00:00
23658 10 021427 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm114966.htm 2005-07-29 00:00:00
23659 10 021428 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23660 10 021430 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107296.htm 2006-06-06 00:00:00
23661 10 021444 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-20 00:00:00
23662 10 021450 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101549.htm 2007-01-17 00:00:00
23663 10 021456 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23664 10 021462 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110261.htm 2005-04-15 00:00:00
23665 10 021475 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm
2011-12-20 00:00:00
23666 10 021483 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2006-04-05 00:00:00
23667 10 021488 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23668 10 021515 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23669 10 021575 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23670 10 021594 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23671 10 021677 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110261.htm 2005-04-15 00:00:00
23672 10 021711 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142882.htm 2011-12-21 00:00:00
23673 10 021729 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23674 10 021731 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm
2011-12-20 00:00:00
23675 10 021774 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2007-03-16 00:00:00
23676 10 021782 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109091.htm 2005-08-30 00:00:00
23677 10 021795 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107924.htm 2008-05-14 00:00:00
23678 10 021802 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm
2007-05-10 00:00:00
23679 10 021849 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23680 10 021850 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23681 10 021872 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2007-03-28 00:00:00
23682 10 021880 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109337.htm 2005-12-28 00:00:00
23683 10 021920 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110423.htm 2006-03-02 00:00:00
23684 10 021925 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109136.htm 2007-08-15 00:00:00
23685 10 021928 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm106540.htm 2006-09-01 00:00:00
23686 10 021929 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm108111.htm 2007-02-21 00:00:00
23687 10 021947 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm113690.htm 2007-09-26 00:00:00
23688 10 021999 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23689 10 022014 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm220264.htm 2010-08-09 00:00:00
23690 10 022020 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23691 10 022021 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2008-07-01 00:00:00
23692 10 022024 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109136.htm 2009-11-12 00:00:00
23693 10 022033 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm113425.htm 2012-02-13 00:00:00
23694 10 022043 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23695 10 022056 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23696 10 022066 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142882.htm 2007-09-24 00:00:00
23697 10 022090 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142882.htm 2011-12-21 00:00:00
23698 10 022101 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23699 10 022161 ORIG 1 0
http://www.fda.gov/drugs/drugsafety/ucm375654.htm 2014-02-07 00:00:00
23700 10 022172 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2007-12-03 00:00:00
23701 10 022192 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23702 10 022196 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2013-04-29 00:00:00
23703 10 022250 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm313009.htm 2012-07-23 00:00:00
23704 10 022267 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm192645.htm 2011-12-20 00:00:00
23705 10 022275 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm350203.htm 2013-12-27 00:00:00
23706 10 022281 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23707 10 022287 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23708 10 022328 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2013-04-29 00:00:00
23709 10 022345 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm350197.htm 2013-11-01 00:00:00
23710 10 022460 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm
2011-12-20 00:00:00
23711 10 022511 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
2011-12-20 00:00:00
23712 10 022532 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm257168.htm 2011-11-16 00:00:00
23713 10 022567 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283587.htm
2012-02-13 00:00:00
23714 10 022574 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm257168.htm 2011-11-16 00:00:00
23715 10 040050 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm142827.htm 2006-11-27 00:00:00
23716 10 040654 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109364.htm 2006-12-18 00:00:00
23717 10 040660 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109364.htm 2006-12-18 00:00:00
23719 10 040791 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109364.htm 2008-05-30 00:00:00
23720 10 050670 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm343281.htm 2013-03-15 00:00:00
23722 10 050710 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm343281.htm 2013-03-12 00:00:00
23723 10 050711 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm343281.htm 2013-03-12 00:00:00
23724 10 050722 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111294.htm 2009-07-15 00:00:00
23725 10 050730 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm343281.htm 2013-03-12 00:00:00
23726 10 050733 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm343281.htm 2013-03-12 00:00:00
23727 10 050758 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111294.htm 2009-07-15 00:00:00
23728 10 050777 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107845.htm 2005-04-15 00:00:00
23729 10 050817 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm070797.htm 2008-09-19
00:00:00
23730 10 062654 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2007-09-11 00:00:00
23731 10 063239 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23732 10 064216 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118080.htm 2007-06-29 00:00:00
23733 10 065137 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2006-03-03
00:00:00
23734 10 065144 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2006-03-03
00:00:00
23735 10 065145 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2006-03-03
00:00:00
23736 10 065155 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2006-03-03
00:00:00
23737 10 065178 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2006-03-03
00:00:00
23738 10 065204 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23739 10 065224 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23740 10 065230 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23741 10 065262 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23742 10 065266 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2006-06-06
00:00:00
23743 10 065268 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23744 10 065283 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2007-09-24
00:00:00
23745 10 065294 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23746 10 065382 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 2007-09-24
00:00:00
23747 10 065433 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111294.htm 2009-07-15 00:00:00
23748 10 065451 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111294.htm 2009-07-15 00:00:00
23749 10 065457 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111294.htm 2009-07-15 00:00:00
23750 10 065504 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23751 10 065505 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109103.htm 2008-09-19 00:00:00
23752 10 073644 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23753 10 073645 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23754 10 074739 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23755 10 074803 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23756 10 074895 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23757 10 075049 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23758 10 075135 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-08-01 00:00:00
23759 10 075207 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23760 10 075290 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23761 10 075356 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm
2005-08-01 00:00:00
23762 10 075389 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23763 10 075452 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23764 10 075506 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23765 10 075514 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23766 10 075584 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23767 10 075629 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm
2011-12-20 00:00:00
23768 10 075658 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23769 10 075662 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23770 10 075690 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23771 10 075710 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-02-28 00:00:00
23772 10 075719 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm
2006-07-05 00:00:00
23773 10 075755 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23774 10 075761 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23775 10 075763 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23776 10 075773 SUPPL 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23777 10 075807 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23778 10 075865 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23779 10 075877 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm243551.htm 2011-02-17 00:00:00
23780 10 075887 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23781 10 075889 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23782 10 075894 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23783 10 075897 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23784 10 075901 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23785 10 075913 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23786 10 075914 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23787 10 075920 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23788 10 075932 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23789 10 075955 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23790 10 076001 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23791 10 076006 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23792 10 076015 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23793 10 076018 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23794 10 076022 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23795 10 076041 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094305.htm 2003-12-17 00:00:00
23796 10 076052 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm203669.htm 2011-05-26 00:00:00
23797 10 076072 ORIG 1 0
http://www.fda.gov/cder/drug/antidepressants/default.htm 2007-05-09
00:00:00
23798 10 076073 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23799 10 076088 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23800 10 076094 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm143341.htm 2007-03-29 00:00:00
23801 10 076095 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm111315.htm 2005-07-29 00:00:00
23802 10 076119 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109344.htm 2005-08-01 00:00:00
23803 10 076129 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23804 10 076153 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-01-07 00:00:00
23805 10 076163 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23806 10 076165 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23807 10 076184 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-02-28 00:00:00
23808 10 076217 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23809 10 076232 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2006-07-17 00:00:00
23810 10 076241 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109344.htm 2005-08-01 00:00:00
23811 10 076251 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23812 10 076287 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2008-05-30 00:00:00
23813 10 076302 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23814 10 076306 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
23815 10 076307 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109344.htm 2005-08-01 00:00:00
23816 10 076308 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109344.htm 2005-08-01 00:00:00
23817 10 076309 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 2007-
05-09 00:00:00
23818 10 076314 ORIG 1 0
http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 2009-04-14
00:00:00
23819 10 076314 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2008-02-01 00:00:00
23820 10 076356 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094305.htm 2005-07-28 00:00:00
23821 10 076362 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23822 10 076394 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23823 10 076440 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2009-02-04 00:00:00
23824 10 076442 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm
2007-05-08 00:00:00
23825 10 076448 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2008-02-01 00:00:00
23826 10 076458 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23827 10 076465 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm
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23828 10 076503 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094305.htm 2003-12-17 00:00:00
23829 10 076540 ORIG 1 0
http://www.fda.gov/cder/drug/infopage/sertraline/default.htm 2005-08-01
00:00:00
23830 10 076540 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm
2007-03-29 00:00:00
23831 10 076541 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109344.htm 2005-08-01 00:00:00
23832 10 076549 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2008-07-01 00:00:00
23833 10 076685 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm203669.htm 2011-05-26 00:00:00
23834 10 076747 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm143349.htm 2009-11-12 00:00:00
23835 10 076765 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm
2006-06-06 00:00:00
23836 10 076770 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm243551.htm 2011-02-17 00:00:00
23837 10 076799 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109136.htm 2009-11-12 00:00:00
23838 10 076845 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103318.htm 2005-07-28 00:00:00
23839 10 076853 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm243551.htm 2011-02-17 00:00:00
23840 10 076887 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm243551.htm 2011-02-17 00:00:00
23841 10 076919 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2008-11-25 00:00:00
23842 10 076928 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110460.htm 2009-02-04 00:00:00
23843 10 076934 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm
2006-07-05 00:00:00
23844 10 076984 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-09-19 00:00:00
23845 10 076990 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2005-08-01 00:00:00
23846 10 077031 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23847 10 077032 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23848 10 077034 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23849 10 077035 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23850 10 077037 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23851 10 077041 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23852 10 077042 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23854 10 077044 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2005-07-29 00:00:00
23855 10 077069 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2005-07-28 00:00:00
23856 10 077082 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm
2007-07-05 00:00:00
23857 10 077084 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm218691.htm 2010-08-09 00:00:00
23858 10 077086 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm218691.htm 2010-08-09 00:00:00
23859 10 077087 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm218691.htm 2010-08-09 00:00:00
23860 10 077152 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm243551.htm 2011-02-17 00:00:00
23861 10 077166 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm106481.htm 2006-09-12 00:00:00
23862 10 077213 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2006-04-10 00:00:00
23863 10 077238 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103285.htm 2008-07-01 00:00:00
23864 10 077239 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103285.htm 2008-07-01 00:00:00
23865 10 077256 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2007-06-18 00:00:00
23866 10 077311 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm129288.htm 2005-11-21 00:00:00
23867 10 077319 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
23868 10 077381 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23869 10 077469 ORIG 1 0
http://www.fda.gov/cder/drug/infopage/fluoxetine/default.htm 2006-07-31
00:00:00
23870 10 077469 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2008-11-25 00:00:00
23871 10 077470 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2008-07-01 00:00:00
23872 10 077505 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103285.htm 2008-07-01 00:00:00
23873 10 077513 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2008-07-01 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2008-07-01 00:00:00
23875 10 077603 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109350.htm 2008-09-19 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm118073.htm 2008-11-25 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2009-03-19 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm
2007-08-16 00:00:00
23882 10 077690 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm203669.htm 2011-05-26 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2008-04-25 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm203669.htm 2011-05-26 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm203669.htm 2011-05-26 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm203669.htm 2011-05-26 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2008-12-18 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm
2007-07-05 00:00:00
23893 10 078115 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101557.htm 2008-05-14 00:00:00
23895 10 078143 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2008-01-30 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm103285.htm 2009-01-06 00:00:00
23897 10 078155 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm203669.htm 2008-02-28 00:00:00
23898 10 078156 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-09-19 00:00:00
23899 10 078216 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm
2007-04-10 00:00:00
23900 10 078269 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2008-11-25 00:00:00
23901 10 078314 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110423.htm 2007-05-08 00:00:00
23902 10 078320 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2007-06-18 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110510.htm 2009-03-03 00:00:00
23904 10 078346 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2008-05-02 00:00:00
23905 10 078406 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm
2007-08-16 00:00:00
23906 10 078432 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110423.htm 2007-05-08 00:00:00
23907 10 078450 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2007-09-24 00:00:00
23908 10 078457 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2007-09-24 00:00:00
23909 10 078462 ORIG 1 0
http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 2008-02-01
00:00:00
23910 10 078486 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm110423.htm 2007-08-16 00:00:00
23911 10 078493 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm102981.htm 2008-09-19 00:00:00
23912 10 078520 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm101551.htm 2008-11-25 00:00:00
23913 10 078619 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109352.htm 2008-02-28 00:00:00
23914 10 078630 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23915 10 078638 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23928 10 079088 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23932 10 086101 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23933 10 087266 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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00:00:00
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23938 10 090162 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
23939 10 090263 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
23940 10 090278 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm107834.htm 2009-04-14 00:00:00
23941 10 103691 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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00:00:00
23942 10 103705 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23944 10 103836 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109130.htm 2007-03-09 00:00:00
23945 10 103846 ORIG 1 0

http://wcms.fda.gov/FDAgov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatie
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23948 10 125103 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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23949 10 125160 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109340.htm 2008-09-04 00:00:00
23950 10 125289 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm109340.htm 2011-12-20 00:00:00
23951 10 125326 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm379961.htm 2013-12-27 00:00:00
23952 10 125399 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm287672.htm 2012-02-13 00:00:00
23953 10 125427 ORIG 1 0
http://www.fda.gov/drugs/drugsafety/ucm350733.htm 2014-02-07 00:00:00
23954 10 200603 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm094303.htm 2011-12-22 00:00:00
23955 10 201917 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm332743.htm 2012-12-27 00:00:00
23956 10 202100 ORIG 1 0
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm
2013-12-27 00:00:00
23957 10 203188 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm323671.htm 2012-10-12 00:00:00
23958 12 021457 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021457s003Exclultr.pdf
2006-02-08 00:00:00
23961 14 019384 ORIG 1 Medication Guide
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf2011-03-15
00:00:00
23962 14 019516 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2012-07-11 00:00:00
23963 14 019643 SUPPL 85 Tracked Changes Label
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085-
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23964 14 019676 SUPPL 20 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
23965 14 019813 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2012-07-11 00:00:00
23967 14 020007 ORIG 1 Other Important Information from FDA

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
oviders/ucm271924.htm 2011-12-20 00:00:00
23968 14 020007 ORIG 1 Pediatric Written Request

http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020007_Zofran_Pediatric_Wri
tten_Request.pdf 2007-07-09 00:00:00
23969 14 020272 SUPPL 7 Clinical Pharmacology & Biopharmaceutics
Review

http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588s002_20272s007_Risperdal.
htm 2004-11-03 00:00:00
23970 14 020394 SUPPL 4 Approval PAckage
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020394Orig1s004.pdf
2011-12-16 00:00:00
23971 14 020522 SUPPL 22 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
23972 14 020522 SUPPL 22 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
23974 14 020671 SUPPL 10 PEDIATRIC STUDIES

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671SE8010PEDS.pdf
2003-03-26 00:00:00
23975 14 020687 SUPPL 14 REMS approved 6/8/2011
http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-
08_Full.pdf 2016-03-30 00:00:00
23976 14 020687 SUPPL 20 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=35 2016-03-30 00:00:00
23978 14 020712 SUPPL 29 Clinical Review

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/016608s098,020712s029,021710
_ClinRev.pdf 2007-12-31 00:00:00
23979 14 020732 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=352 2012-01-05 00:00:00
23980 14 020757 SUPPL 18 Review Part 2
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
757s018_Avapro_P2.pdf 2005-04-27 00:00:00
23981 14 020757 SUPPL 25 Review Part 1
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
757s025_Avapro_P1.pdf 2005-07-29 00:00:00
23982 14 020757 SUPPL 25 Review Part 2
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
757s025_Avapro_P2.pdf 2005-07-29 00:00:00
23983 14 020757 SUPPL 28 Review Part 1
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
757s028_Avapro_P1.PDF 2005-07-29 00:00:00
23984 14 020785 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=58 2010-08-16 00:00:00
23987 14 021015 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=4 2011-04-04 00:00:00
23988 14 021107 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=29 2010-10-01 00:00:00
23989 14 021260 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2012-07-11 00:00:00
23990 14 021290 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=61 2013-02-04 00:00:00
23992 14 021306 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2010-08-05 00:00:00
23994 14 021321 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=18 2011-03-25 00:00:00
23996 14 021338 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=346 2015-07-02 00:00:00
23997 14 021366 SUPPL 10 Approval Package
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366Orig1s010.pdf
2011-12-16 00:00:00
23998 14 021366 SUPPL 10 NDA Review
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366Orig1s010.pdf
2011-11-01 00:00:00
23999 14 021430 ORIG 1 REMS

http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPat
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24000 14 021454 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=56 2015-07-07 00:00:00
24001 14 021473 ORIG 1 ReviewApproval
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021473Orig1s000Approv.pdf
2016-02-03 00:00:00
24002 14 021511 SUPPL 6 Release 2 Letter

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006_rerelease2_
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24003 14 021511 SUPPL 6 Release Letter

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006_rerelease_l
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24004 14 021590 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=351 2015-09-16 00:00:00
24005 14 021647 ORIG 1 FDA Public Health Advisory

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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24006 14 021674 ORIG 1 Approved Labeling 10/10/2013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021674-10-
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24007 14 021744 ORIG 1 Medication Guide
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239933.pdf2011-01-13
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24008 14 021749 ORIG 1 Questions and Answers

http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm1
30314.htm 2004-08-11 00:00:00
24010 14 021775 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=15 2008-05-28 00:00:00
24011 14 021880 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=46 2010-08-16 00:00:00
24012 14 021897 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24013 14 022006 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=48 2011-02-02 00:00:00
24016 14 022081 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24017 14 022110 SUPPL 13 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=65 2016-03-29 00:00:00
24018 14 022173 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=74 2010-03-01 00:00:00
24019 14 022219 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=313 2014-03-13 00:00:00
24020 14 022266 ORIG 1 Medication Guide
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM285397.pdf2011-12-30
00:00:00
24021 14 022266 ORIG 1 Prescriber Information

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000PrescriberInfo.p
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24022 14 022266 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=60 2009-07-17 00:00:00
24023 14 022272 ORIG 1 FDA has determined that this product has
abuse-deterrent properties
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm
2015-11-04 00:00:00
24024 14 022307 SUPPL 8 Priority 3 Approval Package
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022307Orig1s008.pdf
2016-07-29 00:00:00
24029 14 022405 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24032 14 022510 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=60 2011-01-14 00:00:00
24037 14 022580 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=45 2012-07-18 00:00:00
24039 14 050759 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=37 2012-09-27 00:00:00
24040 14 050791 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=37 2012-09-27 00:00:00
24041 14 065413 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=37 2015-07-06 00:00:00
24042 14 065416 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=37 2015-07-06 00:00:00
24043 14 065451 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24044 14 065457 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=37 2015-07-06 00:00:00
24045 14 065491 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24046 14 065520 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24048 14 074769 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24049 14 074862 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
24050 14 074949 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=351 2015-09-16 00:00:00
24051 14 075945 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=24 2015-07-02 00:00:00
24052 14 076135 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=24 2015-07-02 00:00:00
24053 14 076258 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=24 2015-07-02 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
24056 14 076485 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=24 2015-07-02 00:00:00
24057 14 076709 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
24058 14 076733 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
24059 14 076809 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=351 2015-09-16 00:00:00
24060 14 077154 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
24061 14 077312 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=60 2012-02-03 00:00:00
24062 14 077449 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24063 14 078761 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24064 14 079040 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24065 14 079075 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24066 14 087997 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24067 14 090279 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24068 14 090419 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088591.pdf2010-02-05
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http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088988.pdf2010-02-05
00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000ODMemo.pdf
2012-06-13 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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2012-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202121Orig1s000LBL.pdf
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM318435.pdf2012-08-30
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.fda.gov/downloads/Drugs/DrugSafety/UCM287863.pdf2012-06-15
00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=60 2012-02-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806Orig1s000ODMemo.pdf
2013-06-07 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=17 2015-06-30 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=RemsDetails.page&REMS=351 2013-02-08 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=27 2013-01-30 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=41 2013-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000ODMemo.pdf
2013-06-07 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=76 2013-11-01 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
event=IndvRemsDetails.page&REMS=344 2015-02-25 00:00:00
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http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm
2015-11-04 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm
2015-11-04 00:00:00
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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24132 14 208090 ORIG 1 REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692Orig1s000pkglbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s020pi.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020753s007PatientInfo.pdf
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http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPat
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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24171 16 078005 ORIG 1 0

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPr
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140s000SumR.pdf
2010-03-11 00:00:00
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020606se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020639se1-
037_SUMR.pdf 2008-07-16 00:00:00
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051SumR.pdf
2011-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866Orig1s000SumR.pdf
2011-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020883se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947s000sumr.pdf
2010-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020973se022_SUMR.
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf
2015-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021201s000_Sumr.pdf
2010-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021217s000SumR.pdf
2010-05-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s06202
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012SUMR.pdf
2009-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021319se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359Orig1s000SumR.pdf
2012-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021366s016SumR.pdf
2010-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010_SumR.pdf
2009-12-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000_SumR.pdf
2008-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018_SumR.pdf
2009-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,2
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,2
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http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,2
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028SumR.pdf
2012-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463Orig1s000SumR.pdf
2011-09-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519s000_SumR.pdf
2008-11-10 00:00:00
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000sumr.pdf
2010-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021641S008_SumR.pdf
2010-01-22 00:00:00
24208 21 021658 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000_SumR.pdf
2009-07-20 00:00:00
24209 21 021713 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,2
1713s14s15s017SUMR.pdf 2008-07-17 00:00:00
24210 21 021713 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,2
1713s14s15s017SUMR.pdf 2008-07-17 00:00:00
24211 21 021721 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-
047,020635se5-051,021721se5-015_SUMR.pdf 2008-07-16 00:00:00
24212 21 021721 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061,%20020635Ori
g1s067,%20021721Orig1s028SumR.pdf 2015-03-10 00:00:00
24213 21 021729 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,2186
6s6s7s9SUMR.pdf 2008-07-17 00:00:00
24214 21 021729 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,2186
6s6s7s9SUMR.pdf 2008-07-17 00:00:00
24215 21 021747 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747Orig1s000SumR.pdf
2012-08-16 00:00:00
24216 21 021795 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021795s000_SumR.pdf
2009-08-26 00:00:00
24217 21 021813 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813s000_SumR.pdf
2009-06-09 00:00:00
24218 21 021814 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005,%2022-
292s000sumr.pdf 2010-05-12 00:00:00
24219 21 021817 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021817se1-
001_SUMR.pdf 2008-07-17 00:00:00
24220 21 021830 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021830s000_SUMR.p
df 2008-07-17 00:00:00
24221 21 021856 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000_SumR.pdf
2009-04-07 00:00:00
24222 21 021866 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021866s000_SumR.pdf
2008-08-12 00:00:00
24223 21 021879 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000SumR.pdf
2011-06-09 00:00:00
24224 21 021883 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000SumR.pdf
2014-06-25 00:00:00
24225 21 021894 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021894s000_SumR.pdf
2008-10-09 00:00:00
24226 21 021908 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021908se1-
005_SUMR.pdf 2008-07-17 00:00:00
24227 21 021912 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912s000_SumR.pdf
2009-04-14 00:00:00
24228 21 021918 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021918s000_SumR_P1.pdf
2009-10-06 00:00:00
24229 21 021952 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021952s000_SUMR.p
df 2008-07-17 00:00:00
24230 21 021998 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998s000_SumR.pdf
2009-11-24 00:00:00
24231 21 022006 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000_SumR.pdf
2009-10-16 00:00:00
24232 21 022009 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009s000_SumR.pdf
2010-01-13 00:00:00
24233 21 022026 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022026s000_SumR.pdf
2009-02-02 00:00:00
24234 21 022033 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022033s000_SumR.pdf
2008-08-11 00:00:00
24235 21 022037 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022037s000sumr.pdf
2010-07-09 00:00:00
24236 21 022038 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022038s000_SUMR.pdf
2009-12-30 00:00:00
24237 21 022056 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056s000SumR.pdf
2010-03-16 00:00:00
24238 21 022058 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022058s000_SumR.pdf
2008-12-02 00:00:00
24240 21 022090 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022090s000_SumR.pdf
2008-08-19 00:00:00
24241 21 022106 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022106s000_SumR.pdf
2008-07-22 00:00:00
24242 21 022108 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022108s000_SumR.pdf
2009-04-07 00:00:00
24243 21 022115 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022115s000_SumR.pdf
2010-02-14 00:00:00
24244 21 022117 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000_SumR.pdf
2009-10-02 00:00:00
24245 21 022122 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022122_SumR.pdf 2008-
02-22 00:00:00
24246 21 022124 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022124s000_SumR.pdf
2009-11-12 00:00:00
24247 21 022127 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022127s000_SumR.pdf
2008-08-29 00:00:00
24248 21 022129 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000_SumR.pdf
2009-06-01 00:00:00
24249 21 022134 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000SumR.pdf
2011-02-17 00:00:00
24250 21 022145 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_SumR.pdf 2008-
02-22 00:00:00
24251 21 022160 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160s000SumR.pdf
2010-05-06 00:00:00
24252 21 022165 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000SumR.pdf
2010-05-27 00:00:00
24253 21 022181 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022181s000_SumR.pdf
2008-07-22 00:00:00
24254 21 022192 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000TOC.cfm
2009-06-12 00:00:00
24255 21 022193 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022193s000_SumR.pdf
2009-09-21 00:00:00
24256 21 022195 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.p
df 2009-04-01 00:00:00
24257 21 022196 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000_SumR.pdf
2009-07-22 00:00:00
24258 21 022201 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022201s000_SumR.pdf
2009-02-17 00:00:00
24259 21 022205 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022205Orig1s000SumR.pdf
2013-06-04 00:00:00
24260 21 022207 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.p
df 2009-04-01 00:00:00
24261 21 022211 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022211s000_SumR.pdf
2010-01-05 00:00:00
24262 21 022224 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022224s000_SumR.pdf
2009-05-28 00:00:00
24263 21 022225 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022225Orig1s000SumR.pdf
2016-02-04 00:00:00
24264 21 022233 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022233s000Sumr.pdf
2010-05-12 00:00:00
24265 21 022252 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1_SumR.pdf
2010-06-06 00:00:00
24266 21 022254 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000_SumR.p
df 2008-12-17 00:00:00
24267 21 022257 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-
1_021304s007sumr.pdf 2010-05-27 00:00:00
24268 21 022262 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022262s000_SumR.pdf
2009-08-27 00:00:00
24269 21 022267 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022267s000_SumR.pdf
2009-09-03 00:00:00
24270 21 022268 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000_SumR.pdf
2009-07-08 00:00:00
24271 21 022273 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273s000_SumR.pdf
2009-05-28 00:00:00
24272 21 022275 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000_SumR.pdf
2009-07-21 00:00:00
24273 21 022283 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000SumR.pdf
2014-12-09 00:00:00
24274 21 022285 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022285s000_SumR.pdf
2009-01-06 00:00:00
24275 21 022287 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000_SumR.pdf
2009-06-24 00:00:00
24276 21 022290 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022290s000_SumR.pdf
2008-10-23 00:00:00
24277 21 022303 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022303s000_SumR.pdf
2009-08-27 00:00:00
24278 21 022304 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_SumR.pdf
2009-01-25 00:00:00
24279 21 022311 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000_SumR.pdf
2009-03-24 00:00:00
24280 21 022314 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000_SumR.pdf
2009-09-02 00:00:00
24281 21 022318 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022318s000_SumR.pdf
2011-02-03 00:00:00
24282 21 022320 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320s000_SumR.pdf
2010-01-13 00:00:00
24283 21 022325 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325s000_SumR.pdf
2010-02-17 00:00:00
24284 21 022328 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000SumR.pdf
2012-09-05 00:00:00
24285 21 022334 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022334s000_SumR.pdf
2009-05-15 00:00:00
24286 21 022348 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022348s000SumR.pdf
2010-03-11 00:00:00
24287 21 022353 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022353s000_SumR.pdf
2010-02-18 00:00:00
24288 21 022360 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360s000_SumR.pdf
2009-12-30 00:00:00
24289 21 022362 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022362s000sumr.pdf
2010-03-31 00:00:00
24290 21 022369 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369s000_SumR.pdf
2009-08-27 00:00:00
24291 21 022372 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372Orig1s000SumR.pdf
2011-09-16 00:00:00
24292 21 022377 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377Orig1s000SumR.pdf
2011-05-11 00:00:00
24293 21 022382 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022382Orig1s000SumR.pdf
2011-05-03 00:00:00
24294 21 022383 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000SumR.pdf
2011-08-12 00:00:00
24295 21 022401 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/22401s000sumr.pdf
2010-03-31 00:00:00
24296 21 022402 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402s000_SumR.pdf
2009-12-30 00:00:00
24297 21 022404 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404Orig1s000SumR.pdf
2010-12-23 00:00:00
24298 21 022407 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022407Orig1s000SumR.pdf
2013-07-03 00:00:00
24299 21 022408 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408Orig1s000SumR.pdf
2011-02-17 00:00:00
24300 21 022410 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000SumR.pdf
2011-08-12 00:00:00
24301 21 022416 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm
2013-12-20 00:00:00
24302 21 022417 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022417s000_SumR.pdf
2010-06-06 00:00:00
24303 21 022421 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000SumR.pdf
2010-08-20 00:00:00
24304 21 022427 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022427s000_SumR.pdf
2010-01-21 00:00:00
24305 21 022428 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428Orig1s000SumR.pdf
2011-06-07 00:00:00
24306 21 022430 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430s000sumr.pdf
2010-05-06 00:00:00
24307 21 022433 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000SumR.pdf
2011-08-23 00:00:00
24308 21 022434 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434Orig1s000SumR.pdf
2011-11-22 00:00:00
24309 21 022436 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022436s000_SumR.pdf
2010-01-13 00:00:00
24310 21 022437 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022437Orig1s000sumr.pdf
2011-02-17 00:00:00
24311 21 022442 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022442Orig1s000SumR.pdf
2012-02-03 00:00:00
24312 21 022450 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450Orig1s000SumR.pdf
2011-04-04 00:00:00
24313 21 022456 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022456s000sumr.pdf
2010-03-25 00:00:00
24314 21 022462 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000SumR.pdf
2011-03-07 00:00:00
24315 21 022465 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000_SumR.pdf
2010-01-22 00:00:00
24316 21 022466 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022466Orig1s000SumR.pdf
2011-02-17 00:00:00
24317 21 022473 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022473s000_SumR.pdf
2010-02-18 00:00:00
24318 21 022474 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000SumR.pdf
2010-09-17 00:00:00
24319 21 022483 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000SumR.pdf
2011-02-17 00:00:00
24320 21 022484 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022484Orig1s000SumR.pdf
2011-02-17 00:00:00
24321 21 022488 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022488s000sumr.pdf
2010-06-22 00:00:00
24322 21 022494 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000SumR.pdf
2011-05-04 00:00:00
24323 21 022497 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497Orig1s000SumR.pdf
2012-07-06 00:00:00
24324 21 022499 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022499s000sumr.pdf
2010-05-12 00:00:00
24325 21 022502 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022502s000SumR.pdf
2010-08-30 00:00:00
24326 21 022503 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022503Orig1s000SumR.pdf
2015-12-09 00:00:00
24327 14 022505 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24328 21 022512 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000SumR.pdf
2011-02-17 00:00:00
24329 21 022518 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022518Orig1s000SumR.pdf
2011-05-25 00:00:00
24330 21 022519 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519Orig1s000SumR.pdf
2011-11-02 00:00:00
24331 14 022523 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24332 21 022525 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000SumR.pdf
2010-12-23 00:00:00
24333 21 022526 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000SumRedt.pdf
2015-08-24 00:00:00
24334 21 022534 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534Orig1s000SumR.pdf
2012-02-10 00:00:00
24335 14 022542 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24336 21 022548 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022548s000_zymaxid_toc.cfm
2011-02-17 00:00:00
24338 21 022555 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022555Orig1s000SumR.pdf
2011-07-20 00:00:00
24339 21 022556 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000SumR.pdf
2014-06-24 00:00:00
24340 21 022560 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000SumR.pdf
2011-03-21 00:00:00
24341 21 022563 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563Orig1s000SumR.pdf
2011-05-03 00:00:00
24342 21 022567 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000SumR.pdf
2011-03-01 00:00:00
24343 21 022568 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022568Orig1s000SumR.pdf
2011-02-17 00:00:00
24344 21 022572 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022572Orig1s000SumR.pdf
2013-01-02 00:00:00
24345 21 022580 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000SumR.pdf
2013-04-08 00:00:00
24346 21 050807 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050807s000_SumR.pdf
2008-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813s000sumr.pdf
2010-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818s000sumr.pdf
2010-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819s000_SumR_P1.pdf
2009-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821s000SumR.pdf
2010-08-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823Orig1s000SumR.pdf
2012-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050824Orig1s000SumR.pdf
2011-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166SumR.pdf
2012-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173SumR.pdf
2012-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110_SumR.pdf
2009-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104Orig1s015SumR.pdf
2014-01-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000_SumR.pdf
2010-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274Orig1s001SumR.pdf
2011-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000SumR.pdf
2010-03-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000SumR.pdf
2010-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293Orig1s000SumR.pdf
2011-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000SumR.pdf
2010-08-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125360s000SumR.pdf
2011-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf
2011-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387Orig1s000SumR.pdf
2012-01-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000SumR.pdf
2011-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000SumR.pdf
2014-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125399Orig1s000SumR.pdf
2011-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000SumR.pdf
2013-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000SumR.pdf
2014-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000SumR.pdf
2014-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000SumR.pdf
2014-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000SumR.pdf
2014-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486Orig1s000SumR.pdf
2013-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000SumR.pdf
2014-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000SumR.pdf
2015-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125521Orig1s000SumR.pdf
2016-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000SumR.pdf
2015-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000SumR.pdf
2015-01-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045Orig1s000SumR.pdf
2011-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200063Orig1s000SumR.pdf
2014-11-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175Orig1s000SumR.pdf
2011-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199Orig1s000SumR.pdf
2011-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582Orig1s000SumR.pdf
2011-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000SumR.pdf
2013-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200795Orig1s000SumR.pdf
2012-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195Orig1s000SumR.pdf
2012-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf
2011-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf
2013-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373Orig1s000SumR.pdf
2011-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201444Orig1s000SumR.pdf
2012-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201517Orig1s000SumR.pdf
2012-01-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525Orig1s000SumR.pdf
2012-01-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532Orig1s000SumR.pdf
2011-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000SumR.pdf
2014-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201655Orig1s000SumR.pdf
2012-08-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000SumR.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000SumR.pdf
2011-06-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743Orig1s000SumR.pdf
2012-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201820Orig1s000SumR.pdf
2013-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201917Orig1s000SumR.pdf
2011-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201922Orig1s000SumR.pdf
2013-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088Orig2s000SumR.pdf
2013-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000SumR.pdf
2014-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202100Orig1s000SumR.pdf
2013-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202133Orig1s000SumR.pdf
2012-04-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202207Orig1s000SumR.pdf
2013-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211Orig1s000SumR.pdf
2013-11-05 00:00:00
24411 21 202245 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202245Orig1s000SumR.pdf
2012-02-13 00:00:00
24412 21 202270 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf
2013-09-03 00:00:00
24413 21 202278 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000SumR.pdf
2013-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf
2014-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000SumR.pdf
2014-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000SumR.pdf
2012-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429Orig1s000SumR.pdf
2011-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202450Orig1s000SumR.pdf
2012-09-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535Orig1s000SumR.pdf
2012-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202667Orig1s000SumR.pdf
2012-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202736Orig1s000SumR.pdf
2013-01-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810Orig1s000SumR.pdf
2012-11-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895Orig1s000SumR.pdf
2012-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049Orig1s000SumR.pdf
2013-06-04 00:00:00
24425 21 203085 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000SumR.pdf
2012-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000SumR.pdf
2015-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000SumR.pdf
2013-06-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203108Orig1s000SumR.pdf
2014-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168Orig1s000SumR.pdf
2013-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000SumR.pdf
2016-03-02 00:00:00
24431 21 203340 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203340Orig1s000SumR.pdf
2014-03-06 00:00:00
24432 21 203341 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022090s000_SumR.pdf
2012-09-13 00:00:00
24433 21 203389 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203389Orig1s000SumR.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000SumR.pdf
2014-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203491Orig1s000SumR.pdf
2013-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000SumR.pdf
2014-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203510Orig1s000SumR.pdf
2013-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000SumR.pdf
2013-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000SumR.pdf
2014-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000SumR.pdf
2013-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203585Orig1s000SumR.pdf
2012-11-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203595Orig1s000SumR.pdf
2014-01-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634Orig1s000SumR.pdf
2013-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667Orig1s000SumR.pdf
2013-09-20 00:00:00
24445 21 203684 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000SumR.pdf
2014-12-05 00:00:00
24446 21 203696 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203696Orig1s000SumR.pdf
2013-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752Orig1s000SumR.pdf
2013-03-28 00:00:00
24448 21 203756 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203756Orig1s000SumR.pdf
2013-01-04 00:00:00
24449 21 203791 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203791Orig1s000SumR.pdf
2014-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794Orig1s000SumR.pdf
2012-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000SumR.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203923Orig1s000SumR.pdf
2012-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203971Orig1s000SumR.pdf
2013-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203975Orig1s000SumR.pdf
2014-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000SumR.pdf
2013-03-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000SumR.pdf
2013-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000SumR.pdf
2013-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150Orig1s000SumR.pdf
2013-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000SumR.pdf
2013-12-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000SumR.pdf
2014-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204223Orig1s000SumR.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204251Orig1s000SumR.pdf
2013-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204286Orig1s000SumR.pdf
2013-10-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204307Orig1s000SumR.pdf
2013-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204308Orig1s000SumR.pdf
2014-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000SumR.pdf
2014-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000SumR.pdf
2013-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000SumR.pdf
2013-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426Orig1s000SumR.pdf
2013-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000SumR.pdf
2015-01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204592Orig1s000SumR.pdf
2014-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000SumR.pdf
2014-10-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf
2014-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204640Orig1s000SumR.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000SumR.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204655Orig1s000SumR.pdf
2014-12-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000SumR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281
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24618 1 020234 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032l
tr.pdf 2009-05-01 00:00:00
24619 1 020234 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281
s049,s050,018927s041,s042,020234s031,s033ltr.pdf 2011-03-07 00:00:00
24620 1 020234 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,
018927s047,020234s039ltr.pdf 2011-11-10 00:00:00
24621 1 020235 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20235s11ltr.pdf
1998-09-29 00:00:00
24622 1 020235 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf
2000-10-12 00:00:00
24623 1 020235 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,
021129s022ltr.pdf 2011-03-07 00:00:00
24624 1 020235 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,
021129s029ltr.pdf 2010-10-13 00:00:00
24625 1 020235 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s
056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 2013-05-07
00:00:00
24626 1 020235 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s
056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 2013-05-07
00:00:00
24627 1 020235 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882
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24628 1 020236 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20236slr028ltr.pdf
2003-08-14 00:00:00
24629 1 020236 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20
692s026ltr.pdf 2004-10-04 00:00:00
24630 1 020237 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr
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24631 1 020237 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf
2002-06-10 00:00:00
24632 1 020237 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20237scs012ltr.pdf
2003-05-29 00:00:00
24633 1 020238 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020238s015LTR.pdf
2006-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20239se1-
008ltr.pdf 2002-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf
2004-09-21 00:00:00
24636 1 020239 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf
2004-09-21 00:00:00
24637 1 020241 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s2ltr.pdf
1998-08-24 00:00:00
24638 1 020241 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-
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24640 1 020241 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241slr018ltr.pdf
2003-04-18 00:00:00
24641 1 020241 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
24642 1 020241 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s
028s033,022115s004s014,022251s002s009ltr.pdf 2015-01-07 00:00:00
24643 1 020241 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s036,020764s029l
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24644 1 020241 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764
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24645 1 020241 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764
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24646 1 020241 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s
028s033,022115s004s014,022251s002s009ltr.pdf 2015-01-07 00:00:00
24647 1 020241 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764
s036,s037,022251s005,s006ltr.pdf 2010-11-03 00:00:00
24648 1 020241 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,
020764s040,022251s010ltr.pdf 2011-08-08 00:00:00
24649 1 020241 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,
022251s012,022115s016ltr.pdf 2011-12-02 00:00:00
24650 1 020241 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764
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24651 1 020241 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764
Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf 2014-06-12 00:00:00
24652 1 020241 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241
Orig1s053,020764Orig1s046ltr.pdf 2015-05-20 00:00:00
24653 1 020243 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20243S21ltr.pdf
2000-09-28 00:00:00
24654 1 020246 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020246s013ltr.pdf
2005-11-01 00:00:00
24655 1 020246 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020246s035ltr.pdf
2011-08-01 00:00:00
24656 1 020246 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583
Orig1s026ltr.pdf 2015-01-26 00:00:00
24657 1 020249 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf
2002-06-06 00:00:00
24658 1 020249 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034,
019510s031, 020249s013ltr.pdf 2007-11-08 00:00:00
24659 1 020250 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20250slr007,008ltr.pdf
2002-08-01 00:00:00
24660 1 020251 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantacefferdose_approv
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24661 1 020251 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf
2002-01-07 00:00:00
24662 1 020251 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,
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24663 1 020254 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020254s018ltr.pdf
2009-02-27 00:00:00
24664 1 020254 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf
2011-02-28 00:00:00
24665 1 020254 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020254Orig1s028ltr.pdf
2016-05-12 00:00:00
24666 1 020255 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf
2003-07-28 00:00:00
24667 1 020255 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020255Orig1s016ltr.pdf
2013-04-23 00:00:00
24668 1 020258 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20258slr019ltr.pdf
2004-06-08 00:00:00
24669 1 020261 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_che
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24670 1 020261 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-
192_Lescol_Approv.pdf 2004-06-08 00:00:00
24671 1 020261 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr
.pdf 2005-01-11 00:00:00
24672 1 020261 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035,
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24673 1 020261 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012l
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24674 1 020261 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019l
tr.pdf 2012-02-28 00:00:00
24675 1 020262 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262s24ltr.pdf
1998-06-30 00:00:00
24676 1 020262 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf
1998-04-09 00:00:00
24677 1 020262 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf
1998-04-09 00:00:00
24678 1 020262 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20262S33LTR.PDF
1999-10-25 00:00:00
24679 1 020262 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262slr035ltr.pdf
2002-08-29 00:00:00
24680 1 020262 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20262S36LTR.PDF
2000-06-20 00:00:00
24681 1 020262 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf
2002-03-04 00:00:00
24682 1 020262 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf
2002-03-04 00:00:00
24683 1 020262 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020262s048ltr.pdf
2010-09-07 00:00:00
24684 1 020262 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020262s049ltr.pdf
2011-05-04 00:00:00
24685 1 020262 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020262Orig1s051ltr.pdf
2015-03-04 00:00:00
24686 1 020263 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr022ltr.pdf
2003-10-31 00:00:00
24687 1 020263 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr023ltr.pdf
2003-12-24 00:00:00
24688 1 020263 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20263slr024ltr.pdf
2004-03-10 00:00:00
24689 1 020263 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020263s026ltr.pdf
2005-11-18 00:00:00
24690 1 020263 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020263s033ltr.pdf
2009-06-30 00:00:00
24691 1 020263 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020263s035ltr.pdf
2010-09-02 00:00:00
24692 1 020263 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s036ltr.pdf
2011-08-17 00:00:00
24693 1 020263 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s037ltr.pdf
2011-10-12 00:00:00
24694 1 020267 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20267s009ltr.pdf
2004-09-03 00:00:00
24695 1 020267 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020267s012ltr.pdf
2008-06-23 00:00:00
24696 1 020267 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020267s013ltr.pdf
2009-05-29 00:00:00
24697 1 020272 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf
2002-03-03 00:00:00
24698 1 020272 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr01
6,21444slr005ltr.pdf 2003-11-28 00:00:00
24699 1 020272 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-
26,27,20588se1-017,018,21444se1-002,003ltr.pdf 2003-12-11 00:00:00
24700 1 020272 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr02
1,20272slr033ltr.pdf 2004-06-16 00:00:00
24701 1 020272 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24
,s28,s29,21444s8,s15LTR.pdf 2006-10-18 00:00:00
24702 1 020272 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24
,s28,s29,21444s8,s15LTR.pdf 2006-10-18 00:00:00
24703 1 020272 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,
021444s016,021346s010ltr.pdf 2005-08-19 00:00:00
24704 1 020272 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s
37,21444s20s21ltr.pdf 2007-08-22 00:00:00
24705 1 020272 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062
,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 2010-09-07 00:00:00
24706 1 020272 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,
021444s034,021346s036ltr.pdf 2011-08-26 00:00:00
24707 1 020272 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444
s042,s035,020588s054,s048ltr.pdf 2011-09-28 00:00:00
24708 1 020272 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062
,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 2010-09-07 00:00:00
24709 1 020272 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,
021444s040,021346s042ltr.pdf 2011-06-17 00:00:00
24710 1 020272 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588
Orig1s053,021444Orig1s041ltr.pdf 2012-08-03 00:00:00
24711 1 020272 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444
s042,s035,020588s054,s048ltr.pdf 2011-09-28 00:00:00
24712 1 020272 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,
021444s043,021346s044ltr.pdf 2012-03-13 00:00:00
24713 1 020272 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588
Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf 2014-05-09 00:00:00
24714 1 020272 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020273s008ltr.pdf
2005-05-02 00:00:00
24716 14 020280 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24717 14 020280 SUPPL 38 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24718 14 020280 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24719 14 020280 SUPPL 55 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24720 14 020280 SUPPL 57 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24721 14 020280 SUPPL 61 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24722 14 020280 SUPPL 66 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24723 14 020280 SUPPL 68 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24724 14 020280 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24725 14 020280 SUPPL 77 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24726 14 020280 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
24727 1 020281 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-
S014_ULTRAM_APPROV.PDF 2004-06-29 00:00:00
24728 1 020281 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-
S015_ULTRAM_APPROV.PDF 2004-06-29 00:00:00
24729 1 020281 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20281S16LTR.PDF
1999-12-23 00:00:00
24730 1 020281 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf
2009-11-12 00:00:00
24731 1 020281 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf
2009-11-12 00:00:00
24732 1 020286 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915slr038,20286slr00
6ltr.pdf 2003-11-05 00:00:00
24733 1 020287 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_appltr.pdf
1999-05-25 00:00:00
24734 1 020287 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf
2002-04-04 00:00:00
24735 1 020287 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf
2002-04-04 00:00:00
24736 1 020287 SUPPL 29 0

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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020287s049ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020287s050ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s062ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s063ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020291s020LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020291s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020291s029ltr.pdf
2011-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s030ltr.pdf
2012-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297slr011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s030ltr.pdf
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24751 1 020297 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf
2011-01-07 00:00:00
24752 1 020297 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020l
tr.pdf 2011-07-07 00:00:00
24753 1 020297 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020297Orig1s037ltr.pdf
2015-10-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919
Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020304s004.cfm 2020-
03-23 00:00:00
24757 1 020305 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20103s4ltr.pdf
1999-07-27 00:00:00
24758 1 020306 SUPPL 5 0

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.PDF 2004-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020309Orig1s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020310s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020312s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020312s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312Orig1s035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020313s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020313Orig1s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20315S6LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S21LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf
2003-12-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020327Orig1s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020327Orig1s008ltr.pdf
2014-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020327Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20329s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20329slr015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020329Orig1s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020330s022,
s024LTR.pdf 2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020330s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020333s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020333s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020333Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020333Orig1s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20337slr005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020340Orig1s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19057s15ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351scp011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351scp016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020353s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020353s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20355slr004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020355s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020356s019ltr_CKD.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20357S20ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf
2002-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20358s19ltr.pdf
2001-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358s027ltr.pdf
2002-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358scm028ltr.pdf
2002-07-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20358slr030ltr.pdf
2004-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21
515s009,20711s021ltr.pdf 2005-01-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s035,
20358s042ltr.pdf 2007-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036,
020358s043, 021515s020, 020711s029ltr.pdf 2007-08-07 00:00:00
24826 1 020358 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s038,020358s045l
tr.pdf 2010-05-27 00:00:00
24827 1 020358 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,
020358s046,020358s047ltr.pdf 2009-07-07 00:00:00
24828 1 020358 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,
s049ltr.pdf 2011-05-19 00:00:00
24829 1 020358 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050l
tr.pdf 2011-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;0
20358Orig1s053,s054ltr.pdf 2013-12-26 00:00:00
24831 1 020358 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s048,020358
Orig1s055ltr.pdf 2014-12-17 00:00:00
24832 1 020358 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018644Orig1s050,020358
Orig1s057ltr.pdf 2016-04-27 00:00:00
24833 1 020363 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf
1998-06-12 00:00:00
24834 1 020363 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20363S19LTR.PDF
2001-03-29 00:00:00
24835 1 020363 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s026ltr.pdf
2006-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027,
020363s028LTR.pdf 2006-08-04 00:00:00
24837 1 020363 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020363s034ltr.pdf
2008-12-24 00:00:00
24838 1 020363 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020363s036ltr.pdf
2009-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020363s037ltr.pdf
2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf
2012-02-13 00:00:00
24841 1 020364 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-
S008_Lotrel_Approv.pdf 1999-06-16 00:00:00
24842 1 020364 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20364s016LTR.pdf
2002-06-20 00:00:00
24843 1 020364 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020364s023ltr.pdf
2006-04-13 00:00:00
24844 1 020364 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364slr024ltr.pdf
2004-07-06 00:00:00
24845 1 020364 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s039ltr.pdf
2007-09-06 00:00:00
24846 1 020364 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s046ltr.pdf
2009-11-19 00:00:00
24847 1 020364 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020364s047ltr.pdf
2010-04-02 00:00:00
24848 1 020364 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s050ltr.pdf
2011-01-07 00:00:00
24849 1 020364 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s052ltr.pdf
2011-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364s055ltr.pdf
2012-01-23 00:00:00
24851 1 020364 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057lt
r.pdf 2012-10-10 00:00:00
24852 1 020364 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020364Orig1s058ltr.pdf
2014-12-30 00:00:00
24853 1 020364 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s060ltr.pdf
2015-04-23 00:00:00
24854 1 020364 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s061ltr.pdf
2015-05-19 00:00:00
24855 1 020369 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.
pdf 2003-08-28 00:00:00
24856 1 020369 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf
2004-07-21 00:00:00
24857 1 020372 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20372scm011ltr.pdf
2002-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020372s019ltr.pdf
2005-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020372s022ltr.pdf
2009-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020375s023ltr.pdf
2006-01-06 00:00:00
24861 1 020375 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s028ltr.pdf
2013-10-31 00:00:00
24862 1 020377 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20377s4s5ltr.pdf
2001-07-11 00:00:00
24863 1 020377 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.p
df 2004-11-08 00:00:00
24864 1 020377 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr010,012ltr.pdf
2003-05-30 00:00:00
24865 1 020377 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr013ltr.pdf
2003-05-30 00:00:00
24866 1 020377 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020397Orig1s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020403s014rev2.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020405Orig1s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020405Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20406S33ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20406S38ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406se5-
047LTR.pdf 2002-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076ltr,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428
Orig1s027ltr.pdf 2015-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20408se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020408Orig1s050ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020411s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020412s036,020413s028l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415s9ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020415Orig1s031,021208
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020427s002,022006s002l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020427Orig1s013,022006
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020427Orig1s014,022006
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020427Orig1s015,022006
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/020438-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20438s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20439s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20441s2.ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020441s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20444S03LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020448s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20449S11LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020449s045ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s069ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020449Orig1s075ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020450Orig1s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20451s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020452s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457s3s4ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020457s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20458s2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20463s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020468Orig1s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20471slr009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020471s014,022052s005l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020471s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020472s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020472Orig1s012,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020474s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20478slr007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20478slr012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020478s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020478s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20482s7-8ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20482slr011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020482s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20484s2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020484s006LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020484s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020484s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20485s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20485scm006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020485Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20487s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020487s007rel2_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020487s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020487s016ltr.pdf
2010-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020488Orig1s019ltr.pdf
2013-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489s7ltr.pdf
2002-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489slr010ltr.pdf
2002-08-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020489s025ltr.pdf
2011-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020489Orig1s027ltr.pdf
2012-05-02 00:00:00
25041 1 020489 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020489Orig1s033ltr.pdf
2015-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine
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25043 1 020496 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf
2004-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf
2005-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018,
s019ltr.pdf 2009-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf
2009-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf
2012-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf
2013-08-05 00:00:00
25049 1 020496 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf
2013-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020498s016ltr.pdf
2005-05-17 00:00:00
25051 1 020498 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020498s018ltr.pdf
2006-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf
2009-03-16 00:00:00
25053 1 020498 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020498Orig1s025ltr.pdf
2015-03-02 00:00:00
25054 1 020500 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20500s5ltr.pdf
2004-06-09 00:00:00
25055 1 020500 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020500Orig1s014ltr.pdf
2013-03-04 00:00:00
25056 1 020503 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20503s4ltr.pdf
1998-09-23 00:00:00
25057 1 020503 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20503slr022ltr.pdf
2004-02-03 00:00:00
25058 1 020504 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020504s018ltr.pdf
2011-03-21 00:00:00
25059 1 020505 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl
.pdf 1999-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20505S002ltr.pdf
2001-08-28 00:00:00
25061 1 020505 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl
.pdf 1999-10-01 00:00:00
25062 1 020505 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr015,20844slr01
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25063 1 020505 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20505slr013,20844slr01
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25064 1 020505 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s
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25065 1 020505 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020505s029,
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25067 1 020505 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s
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25068 1 020505 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844
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25070 1 020505 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844
s035,s037ltr.pdf 2011-03-08 00:00:00
25071 1 020505 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s052,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s053,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20508S5ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20508s006ltr.pdf
2004-12-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20509slr013ltr.pdf
2005-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s032ltr.pdf
2005-04-28 00:00:00
25078 1 020509 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s039_ltr.pdf
2006-07-21 00:00:00
25079 1 020509 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020509s064ltr.pdf
2010-03-24 00:00:00
25080 1 020509 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s077ltr.pdf
2014-05-12 00:00:00
25081 1 020516 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020516s022ltr.pdf
2010-10-22 00:00:00
25082 1 020516 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020516s024ltr.pdf
2011-12-08 00:00:00
25083 1 020516 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020516Orig1s033ltr.pdf
2016-06-21 00:00:00
25084 1 020517 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr02
3ltr.pdf 2003-09-25 00:00:00
25085 1 020517 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
222420517181920708202120011tr.pdf 2005-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,
s035,s036,020517s024,s028,s029ltr.pdf 2010-05-04 00:00:00
25087 1 020517 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032lt
r.pdf 2011-06-29 00:00:00
25088 1 020517 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,
s035,s036,020517s024,s028,s029ltr.pdf 2010-05-04 00:00:00
25089 1 020517 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,
020517Orig1s031ltr_C.pdf 2011-01-20 00:00:00
25090 1 020517 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517
Orig1s036ltr.pdf 2014-07-01 00:00:00
25091 1 020517 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517
Orig1s038ltr.pdf 2016-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF
2001-03-30 00:00:00
25093 1 020518 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr02
7,20518slr011ltr.pdf 2004-03-11 00:00:00
25094 1 020518 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019655s048,020518s018l
tr.pdf 2010-01-06 00:00:00
25095 1 020518 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,
020518s019ltr.pdf 2010-05-21 00:00:00
25096 1 020518 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,
020518s022ltr.pdf 2011-12-01 00:00:00
25097 1 020518 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,
020518s023ltr.pdf 2012-06-04 00:00:00
25098 1 020518 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910
Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf 2014-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s028ltr.pdf
2015-02-03 00:00:00
25100 1 020520 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s030ltr.pdf
2015-11-23 00:00:00
25101 1 020520 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020520Orig1s032ltr.pdf
2016-02-17 00:00:00
25102 1 020520 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520
Orig1s033ltr.pdf 2016-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf 2020-
03-23 00:00:00
25104 1 020521 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020521s024ltr.pdf
2020-03-23 00:00:00
25105 14 020522 SUPPL 9 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25106 14 020522 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25107 14 020522 SUPPL 22 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25108 14 020522 SUPPL 26 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25109 14 020522 SUPPL 27 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25110 14 020522 SUPPL 33 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25111 14 020522 SUPPL 36 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25112 14 020522 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25113 1 020527 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20527r.pdf
1998-01-09 00:00:00
25114 1 020527 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527s018ltr.pdf
2002-02-11 00:00:00
25115 1 020527 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-
024,slr026,slr031ltr.pdf 2003-06-08 00:00:00
25116 1 020527 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527slr029ltr.pdf
2002-11-27 00:00:00
25117 1 020527 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf
2004-04-29 00:00:00
25118 1 020527 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020527s036ltr.pdf
2005-07-08 00:00:00
25119 1 020527 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s045ltr.pdf
2010-01-06 00:00:00
25120 1 020527 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s046ltr.pdf
2009-05-26 00:00:00
25121 1 020527 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s
056ltr.pdf 2012-02-07 00:00:00
25122 1 020528 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020528s016ltr.pdf
2009-04-16 00:00:00
25123 1 020528 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s019ltr.pdf
2011-09-16 00:00:00
25124 1 020528 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020l
tr.pdf 2012-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020528Orig1s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020528Orig1s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020533s014LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020541s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20544se2-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20545scm007.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20547slr017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020547s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020547s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020547s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020547Orig1s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr016,015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20549slr014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550slr021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20551se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020551s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020554s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560s12ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S23ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s061,021575s021l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s082ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20596S13LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s015ltrand20596s0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s022,20564s021ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s025,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020564s031,020596s030l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s035,020596
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020570s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20571s8ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20571s9ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20571s016ltr.pdf
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021ltr.pdf 2004-06-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20571s023ltr.pdf
2004-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s
036,s037ltr.pdf 2010-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020571Orig1s042ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020572s016,020573s015l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020572s016,020573s015l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20574ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20582_FOLLISTIM%2075IU
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020582s001_follistim_toc.cfm
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20582-
S002_FOLLISTIM_APPROV.PDF 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20583ltr.pdf
1998-03-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-
584S003_Lodine_Approv.pdf 1999-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
584S005_Lodine_Approv.pdf 2000-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.
pdf 2005-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018922s022_020584s009l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf
2002-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24
,s28,s29,21444s8,s15LTR.pdf 2006-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24
,s28,s29,21444s8,s15LTR.pdf 2006-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,
021444s016,021346s010ltr.pdf 2005-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,
021346s027,021444s029ltr.pdf 2008-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444
s042,s035,020588s054,s048ltr.pdf 2011-09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062
,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 2010-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,
021346s040,021444s039ltr.pdf 2010-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,
021444s040,021346s042ltr.pdf 2011-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,
021444s043,021346s044ltr.pdf 2012-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020589s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020589s024ltr.pdf
2009-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020589s026ltr.pdf
2010-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020589Orig1s029ltr.pdf
2013-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020591s016ltr.pdf
2009-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s018ltr.pdf
2011-09-16 00:00:00
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2Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf
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Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf
2014-06-11 00:00:00
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Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf
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5ltr.pdf 2002-10-08 00:00:00
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.pdf 2004-12-02 00:00:00
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.pdf 2004-10-04 00:00:00
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020564s024LTR.pdf 2006-06-20 00:00:00
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Orig1s032ltr.pdf 2015-03-26 00:00:00
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Orig1s033ltr.pdf 2015-02-24 00:00:00
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Orig1s034ltr.pdf 2015-10-02 00:00:00
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Orig1s035ltr.pdf 2016-07-22 00:00:00
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010ltr.pdf 2003-04-04 00:00:00
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.pdf 2003-06-08 00:00:00
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603S002_Ibuprofen_Approv.pdf 1999-09-13 00:00:00
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event=faq.page#nda_bla 2020-03-23 00:00:00
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event=faq.page#nda_bla 2020-03-23 00:00:00
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020605s008rev2.pdf 2006-01-06 00:00:00
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020781s010ltr.pdf 2006-09-18 00:00:00
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020781s014ltr.pdf 2011-09-16 00:00:00
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Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf 2013-12-13 00:00:00
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021140se8-011ltr.pdf 2008-05-05 00:00:00
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Orig1s031ltr.pdf 2015-07-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s061ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s065ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s066ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020685s075ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020687s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020687s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20688S12LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20690slr011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020690s026,021720s003L
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021720Orig1s007,020690
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20692slr024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,
020692s038ltr.pdf 2011-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254
Orig1s019,020692Orig1s042ltr.pdf 2012-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020692Orig1s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20696s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020697s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s013,020697s015l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20698ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698scp004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20699slr029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr03
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s059ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s083ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s091ltr.pdf
2014-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s104ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001//20701S7ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20702ltrs003s005.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20702S18LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20702S25ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20702slr027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20702scs037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20702s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s047ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s049ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s050ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020702s057ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702s060ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020702Orig1s064ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020704s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20705s03ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20707slr004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020707s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-
S014_LUPRON_APPROV.PDF 1998-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020708s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020
710s026s029s033,020936s040s043ltr.pdf 2011-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-711SE8-
012_Zyban_Approv.pdf 2001-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20711s15ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s024LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s042ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020711Orig1s044ltr.pdf
2016-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020712s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20385slr006,20714slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20385s007,20714s012ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020714s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20715ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20715s3ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021288s002,020715s006l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s025,021288s022,
022437s003ltr.pdf 2011-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020715Orig1s032,021288
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20717ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020717s020ltr.pdf
2007-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036lt
r.pdf 2010-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036lt
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25626 1 020717 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038lt
r.pdf 2015-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20718s02ltr.pdf
1999-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf
2001-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020718s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay_appltr.pdf
1999-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20720s12.ltr.pdf
1999-06-16 00:00:00
25632 1 020720 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20720s12.ltr.pdf
1999-06-16 00:00:00
25633 1 020723 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf
2004-05-26 00:00:00
25634 1 020723 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf
2004-05-26 00:00:00
25635 1 020723 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020723s018ltr.pdf
2005-08-11 00:00:00
25636 1 020723 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020723s020LTR.pdf
2007-03-31 00:00:00
25637 14 020725 SUPPL 14 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25638 1 020726 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726se8-
005ltr.pdf 2003-03-10 00:00:00
25639 1 020726 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20726S006LTR.PDF
2001-01-10 00:00:00
25640 1 020726 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20726s011ltr.pdf
2005-01-26 00:00:00
25641 1 020726 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020726s013LTR.pdf
2006-06-27 00:00:00
25642 1 020726 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf
2010-03-08 00:00:00
25643 1 020726 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020726s017ltr.pdf
2008-08-13 00:00:00
25644 1 020726 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020726s018ltr.pdf
2009-07-17 00:00:00
25645 1 020726 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s019ltr.pdf
2010-06-29 00:00:00
25646 1 020726 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020726s024ltr.pdf
2012-01-03 00:00:00
25647 1 020726 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020726Orig1s027ltr.pdf
2014-01-17 00:00:00
25648 1 020727 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020727Orig1s004ltr.pdf
2013-03-29 00:00:00
25649 1 020729 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr02
4ltr.pdf 2003-11-25 00:00:00
25650 1 020729 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020729s021ltr.pdf
2010-01-15 00:00:00
25651 1 020729 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020729s024ltr.pdf
2011-08-26 00:00:00
25652 1 020729 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020729Orig1s026ltr.pdf
2012-09-17 00:00:00
25653 1 020732 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf
2012-01-03 00:00:00
25654 1 020732 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020732Orig1s010ltr.pdf
2014-12-12 00:00:00
25655 1 020732 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733
Orig1s016ltr.pdf 2015-09-24 00:00:00
25656 1 020733 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020733s007,s008ltr.pdf
2012-01-03 00:00:00
25657 1 020733 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020733s007,s008ltr.pdf
2012-01-03 00:00:00
25658 1 020733 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733
Orig1s017,022410Orig1s025ltr.pdf 2016-07-12 00:00:00
25659 1 020734 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and2073
4slr010,011ltr.pdf 2002-07-25 00:00:00
25660 1 020738 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_APPROV.PDF
2004-06-18 00:00:00
25661 1 020738 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020738s026ltr.pdf
2011-05-06 00:00:00
25662 1 020738 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017l
tr.pdf 2012-01-23 00:00:00
25663 1 020738 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738Orig1s028ltr.pdf
2012-09-14 00:00:00
25664 1 020738 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020738Orig1s029ltr.pdf
2014-07-24 00:00:00
25665 1 020740 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20740s02ltr.pdf
1999-05-24 00:00:00
25666 1 020740 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20740S6ltr.pdf
2001-03-30 00:00:00
25667 1 020741 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741se1-
013ltr.pdf 2002-10-21 00:00:00
25668 1 020741 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741slr018ltr.pdf
2003-08-29 00:00:00
25669 1 020742 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742slr003ltr.pdf
2003-07-10 00:00:00
25670 1 020742 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.
pdf 2004-05-26 00:00:00
25671 1 020742 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742s008ltr.pdf
2004-10-04 00:00:00
25672 1 020742 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020742s020ltr.pdf
2009-04-29 00:00:00
25673 1 020742 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr
.pdf 2015-12-22 00:00:00
25674 1 020742 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr
.pdf 2015-12-22 00:00:00
25675 14 020744 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25676 14 020744 SUPPL 4 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25677 14 020744 SUPPL 19 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25678 14 020744 SUPPL 28 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
25679 1 020746 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20746ltr.pdf
1999-10-01 00:00:00
25680 1 020746 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20746s4ltr.pdf
2001-10-26 00:00:00
25681 1 020746 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr01
1,20929slr015ltr.pdf 2003-09-26 00:00:00
25682 1 020746 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s015ltr.pdf
2004-08-31 00:00:00
25683 1 020746 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020746s026ltr.pdf
2011-01-04 00:00:00
25684 1 020746 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020746Orig1s032ltr.pdf
2015-03-25 00:00:00
25685 1 020746 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s034ltr.pdf
2016-04-25 00:00:00
25686 1 020747 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20747S6ltr.pdf
2001-04-11 00:00:00
25687 1 020747 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747slr009ltr.pdf
2003-01-29 00:00:00
25688 1 020747 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s018ltr.pdf
2005-01-26 00:00:00
25689 1 020747 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s019ltr.pdf
2005-09-15 00:00:00
25690 1 020747 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020747s023_ltr.pdf
2007-04-11 00:00:00
25691 1 020747 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020747s027ltr.pdf
2007-02-12 00:00:00
25692 1 020747 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747Orig1s029ltr.pdf
2011-07-21 00:00:00
25693 1 020747 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747s033ltr.pdf
2012-01-03 00:00:00
25694 1 020747 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020747s034ltr.pdf
2012-06-07 00:00:00
25695 1 020747 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020747Orig1s037ltr.pdf
2013-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020747Orig1s041ltr.pdf
2014-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20748ltr.pdf
2000-05-26 00:00:00
25698 1 020749 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20749slr004ltr.pdf
2003-04-15 00:00:00
25699 1 020752 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf
2002-06-06 00:00:00
25700 1 020753 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20753s005ltr.pdf
2004-09-29 00:00:00
25701 1 020753 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020753s007ltr.pdf
2008-12-30 00:00:00
25702 1 020753 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr
.pdf 2011-03-28 00:00:00
25703 1 020753 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr
.pdf 2011-03-28 00:00:00
25704 1 020753 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016lt
r.pdf 2014-05-06 00:00:00
25705 1 020753 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020753Orig1s018ltr.pdf
2016-07-26 00:00:00
25706 1 020756 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S10ltr.pdf
2001-04-23 00:00:00
25707 1 020756 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr011,20756slr01
2ltr.pdf 2003-09-29 00:00:00
25708 1 020757 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020757s037ltr.pdf
2005-11-30 00:00:00
25709 1 020757 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s039ltr.pdf
2006-03-23 00:00:00
25710 1 020757 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s055ltr.pdf
2011-08-02 00:00:00
25711 1 020757 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067lt
r.pdf 2016-02-09 00:00:00
25712 1 020757 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s060ltr.pdf
2012-09-14 00:00:00
25713 1 020757 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020757Orig1s064ltr.pdf
2014-06-02 00:00:00
25714 1 020757 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067lt
r.pdf 2016-02-09 00:00:00
25715 1 020758 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020758s035ltr.pdf
2005-11-30 00:00:00
25716 1 020758 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020758s037ltr.pdf
2007-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020758s050ltr.pdf
2010-09-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf
2011-06-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s060ltr.pdf
2012-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s062ltr.pdf
2012-01-23 00:00:00
25721 1 020758 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020758Orig1s070ltr.pdf
2016-02-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20762s1ltr.pdf
1998-11-18 00:00:00
25723 1 020762 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20762se5011ltr.pdf
2002-07-17 00:00:00
25724 1 020762 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20762slr021ltr.pdf
2003-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20762s023ltr.pdf
2004-12-30 00:00:00
25726 1 020762 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020762s044ltr.pdf
2011-01-25 00:00:00
25727 1 020763 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20763ltr.pdf
1998-02-10 00:00:00
25728 1 020763 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s
010ltr.pdf 2013-10-18 00:00:00
25729 1 020763 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20763slr005ltr.pdf
2003-11-05 00:00:00
25730 1 020763 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020763s006ltr.pdf
2010-08-16 00:00:00
25731 1 020763 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf
2012-03-05 00:00:00
25732 1 020763 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s
010ltr.pdf 2013-10-18 00:00:00
25733 1 020764 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-
017,20764se1-011ltr.pdf 2003-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
25736 1 020764 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,
020764s3,s14,s18,s19,s20LTR.pdf 2013-09-06 00:00:00
25737 1 020764 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764
s030,s031ltr.pdf 2009-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764
s036,s037,022251s005,s006ltr.pdf 2010-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764
s036,s037,022251s005,s006ltr.pdf 2010-11-03 00:00:00
25740 1 020764 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,
020764s040,022251s010ltr.pdf 2011-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,
022251s011ltr.pdf 2011-06-02 00:00:00
25742 1 020764 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,
022251s012,022115s016ltr.pdf 2011-12-02 00:00:00
25743 1 020764 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764
Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf 2012-08-02 00:00:00
25744 1 020764 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,02
0764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 2015-03-25
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764
Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf 2014-06-12 00:00:00
25746 1 020764 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241
Orig1s053,020764Orig1s046ltr.pdf 2015-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20766ltr.pdf
1999-04-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766s019ltr.pdf
2004-10-29 00:00:00
25749 1 020766 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766slr020ltr.pdf
2004-07-14 00:00:00
25750 1 020766 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020766s021ltr.pdf
2005-09-08 00:00:00
25751 1 020766 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020766s022_ltr.pdf
2007-01-12 00:00:00
25752 1 020766 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s030ltr.pdf
2010-12-22 00:00:00
25753 1 020766 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020766Orig1s033ltr.pdf
2013-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768s6ltr.pdf
2002-01-29 00:00:00
25755 1 020768 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr00
3ltr.pdf 2002-10-09 00:00:00
25756 1 020768 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,0
21231Orig1s010,s011ltr.pdf 2012-09-18 00:00:00
25757 1 020769 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020769s011ltr.pdf
2009-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020769Orig1s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20771slr010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20771slr011ltr.pdf
2004-01-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020771s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020771s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020776s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020776s002_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20778S14ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020812Orig1s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20819se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020819s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919O
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020827s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020827s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20828se2-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20829ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830S008_Singulair_Approv.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s032,20830s034,21
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020831s021,021592s003l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832slr006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Origs030,021555O
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020832Orig1s031,021555
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020832Orig1s034,021555
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020833s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020833Orig1s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20834scs007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020834s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029,
s030ltr.pdf 2008-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s035ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20837ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20837scs010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020837Orig1s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20838ltr.pdf
1998-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20838se4-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr017ltr.pdf
2004-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20838s024ltr.pdf
2005-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020838s031ltr.pdf
2009-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020838s033ltr.pdf
2011-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020838Orig1s036ltr.pdf
2015-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020838Orig1s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s19ltr.pdf
2002-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf
2005-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s034LTR.pdf
2006-08-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s035LTR.pdf
2006-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s040ltr.pdf
2009-08-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s042ltr.pdf
2010-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s058ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20841ltr.pdf
1998-03-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20843ltr.pdf
1998-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781slr008,20843slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019781s017,020843s011l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20505S002ltr.pdf
2001-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020505s029,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s052,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s055,020844
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20845ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020845s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20846ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20847ltr.pdf
1998-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20849ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20849scs008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20850slr005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20850slr011ltr.pdf
2004-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020850s013ltr.pdf
2005-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s022,s023ltr.pdf
2009-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s025ltr.pdf
2009-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850Orig1s033ltr.pdf
2012-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850s035ltr.pdf
2012-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020850Orig1s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020855Orig1s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr009,010ltr.pdf
2002-08-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020857s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020857Orig1s030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf
2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20860LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20862ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020862s019ltr.pdf
2006-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020862s030ltr.pdf
2011-02-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020863s011ltr.pdf
2005-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s019ltr.pdf
2007-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s022ltr.pdf
2015-01-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020865s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20868slr006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020868Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020868Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20869s012.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020869s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020869s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20870ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20870s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020870s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020870Orig1s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020870Orig1s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20872ltr.pdf
2000-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020872s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20873ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s006ltr.pdf
2005-06-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20873slr009ltr.pdf
2004-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020873Orig1s029ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020873Orig1s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20882ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20882scs017ltr.pdf
2004-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020235s041,020882s028l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20883s4ltr.pdf
2002-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s009ltr.pdf
2005-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020883se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020883Orig1s018ltr.pdf
2016-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_APPROV.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020884Orig1s035ltr.pdf
2015-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020892Orig1s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020895s021ltr.pdf
2005-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020895s023ltr.pdf
2006-10-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020895Orig1s039,s042lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020895Orig1s044ltr.pdf
2015-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf
2001-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020896Orig1s034ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20897ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20897se8-
013ltr.pdf 2004-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020897s024ltr.pdf
2009-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s029ltr.pdf
2011-12-20 00:00:00
26139 1 020897 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897Orig1s031ltr.pdf
2012-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020897Orig1s032ltr.pdf
2013-08-05 00:00:00
26141 14 020898 SUPPL 29 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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event=faq.page#nda_bla 2020-03-23 00:00:00
26143 14 020898 SUPPL 51 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020899Orig1s015ltr.pdf
2012-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20901ltr.pdf
1998-11-24 00:00:00
26146 1 020902 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_appltr.pdf
1999-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf
1998-12-09 00:00:00
26148 1 020903 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pd
f 2001-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s15ltr.pdf
2002-02-21 00:00:00
26150 1 020903 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s20ltr.pdf
2002-03-06 00:00:00
26151 1 020903 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr025ltr.pdf
2003-07-31 00:00:00
26152 1 020903 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr029ltr.pdf
2003-06-08 00:00:00
26153 1 020903 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr032ltr.pdf
2003-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr033ltr.pdf
2004-06-10 00:00:00
26155 1 020903 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020903s038ltr.pdf
2006-09-18 00:00:00
26156 1 020903 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s040ltr.pdf
2008-01-09 00:00:00
26157 1 020903 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020903s046,021546s002l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020903s048,021546s004l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s051,021546
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020903Orig1s053,021546
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20905ltr.pdf
1998-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20905slr007,20905se1-
006ltr.pdf 2003-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905se5-
012ltr.pdf 2004-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905s014ltr.pdf
2004-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020905s022ltr.pdf
2011-07-12 00:00:00
26167 1 020905 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020905Orig1s025ltr.pdf
2012-11-06 00:00:00
26168 1 020905 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020905Orig1s027ltr.pdf
2015-09-01 00:00:00
26169 1 020906 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20906_Etopophos_appltr_chemr.p
df 1998-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20907ltr.pdf
1998-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020907s005ltr.pdf
2005-07-08 00:00:00
26172 1 020907 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009,
s011ltr.pdf 2007-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009,
s011ltr.pdf 2007-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020907Orig1s013ltr.pdf
2013-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20908ltr.pdf
1999-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020908s017ltr.pdf
2012-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20911slr008ltr.pdf
2003-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf
2001-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf
2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020lt
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF
1999-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s010ltr.pdf
2002-05-17 00:00:00
26186 1 020913 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20918_ltr.pdf
1998-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918slr008ltr.pdf
2004-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020918s017ltr.pdf
2005-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020918s034ltr.pdf
2012-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20919ltr.pdf
2002-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s021,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s024,020919s014l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s027,020919s019l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020919s022ltr.pdf
2008-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s035,020919s023l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919O
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s049,020919
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20920slr003ltr.pdf
2004-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020920s006ltr.pdf
2005-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020922s003ltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20926ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20926S2LTR.PDF
2000-05-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20926se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20928ltr.pdf
1998-09-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20928slr010ltr.pdf
2004-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20929ltr.pdf
2000-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020929s032ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020929s044ltr.pdf
2010-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s010ltr.pdf
2015-11-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s036,020933s027l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s039,020933s030l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020636Orig1s042,020933
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020636Orig1s044,020933
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20934ltr.pdf
1999-02-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20934slr011ltr.pdf
2003-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20934scs012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20936ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20982ltr.pdf
2002-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20936se2-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s021,020031s046l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020936s039ltr.pdf
2009-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf
1999-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s021,020975
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20938ltr.pdf
2000-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20938slr007ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020938s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020938s021,021530s009l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s026ltr.pdf
2016-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20941ltr.pdf
2000-07-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020941Orig1s011ltr.pdf
2015-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20942_Versed_approv.pdf
2004-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20943ltr.pdf
1998-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20943slr013ltr.pdf
2004-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020943s021ltr.pdf
2009-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf
2010-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020943s028ltr.pdf
2011-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020944s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020659s034,020945s017l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020945s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020945Orig1s036ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020947s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020947s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020947Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020949s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020950s012LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020950s032ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20954se2-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954scp005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020954s008_LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020954Orig1s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20955s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020955s010LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020958Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020958Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20961ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20963slr007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966s5ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020969Orig1s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020971s017LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr018,21360slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr021,21360slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s022,21360s006ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020972s026,021360s013l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s031,021360s018l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s033,021360s021l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s035,021360s023l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972Orig1s042,021360
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020972Orig1s046,021360
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021360Orig1s037,020972
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020972Orig1s049,021360
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20973ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21456,20973se8-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973slr014ltr.pdf
2002-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020973s020ltr.pdf
2005-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020973s028ltr.pdf
2011-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973Orig1s029ltr.pdf
2012-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20974ltr.pdf
1999-03-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf
1999-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020975s007ltr.pdf
2005-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022,%20020
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf
1999-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-
937S003_OptiMark_Approv.pdf 2004-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020976s007ltr.pdf
2005-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975
Origs025,020976Orig1s026ltr.pdf 2014-11-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf
2002-01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,
020978s013,020978s014ltr.pdf 2009-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr
.pdf 2004-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014,
020978s016LTR.pdf 2006-08-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016,
020978s019ltr.pdf 2007-05-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019,
020978s022ltr.pdf 2008-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,
021205s024,021652s011ltr.pdf 2010-08-10 00:00:00
26358 1 020977 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,
021205s028,021652s013ltr.pdf 2011-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027l
tr.pdf 2011-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf
1998-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf
2002-01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,
020978s013,020978s014ltr.pdf 2009-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr
.pdf 2004-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20980_appltr.pdf 2004-
06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020980s005ltr.pdf
2007-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020981s000ltr.pdf
2007-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020981Orig1s006ltr.pdf
2014-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020983s016ltr.pdf
2008-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020984s003ltr.pdf
2010-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20985ltr.pdf
2000-10-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20985slr004ltr.pdf
2003-12-19 00:00:00
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event=faq.page#nda_bla 2020-03-23 00:00:00
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event=faq.page#nda_bla 2020-03-23 00:00:00
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event=faq.page#nda_bla 2020-03-23 00:00:00
26381 14 020986 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
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event=faq.page#nda_bla 2020-03-23 00:00:00
26382 14 020986 SUPPL 53 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26383 14 020986 SUPPL 59 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26384 14 020986 SUPPL 60 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26385 14 020986 SUPPL 61 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26386 14 020986 SUPPL 62 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26387 14 020986 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26388 14 020986 SUPPL 75 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf
2001-06-12 00:00:00
26390 1 020987 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr017ltr.pdf
2004-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr023ltr.pdf
2004-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987s026ltr.pdf
2004-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020987s032LTR.pdf
2006-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,
s037ltr.pdf 2009-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020987Orig1s043,022020
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020987Orig1s048,022020
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_Approv.pdf
2001-03-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr007ltr.pdf
2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr015ltr.pdf
2004-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr016ltr.pdf
2003-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr019ltr.pdf
2004-05-07 00:00:00
26402 1 020988 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988scf024ltr.pdf
2004-04-07 00:00:00
26403 1 020988 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr025ltr.pdf
2004-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s029ltr.pdf
2004-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s041ltr.pdf
2011-06-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s042ltr.pdf
2011-12-13 00:00:00
26407 1 020988 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s043ltr.pdf
2011-05-25 00:00:00
26408 1 020988 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988Orig1s044ltr.pdf
2012-10-02 00:00:00
26409 1 020988 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988s045ltr.pdf
2012-05-14 00:00:00
26410 1 020988 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020988Orig1s052ltr.pdf
2014-12-23 00:00:00
26411 1 020989 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020989s008ltr.pdf
2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20990ltr.pdf
1999-12-07 00:00:00
26413 1 020990 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s35ltr.pdf
2001-08-17 00:00:00
26415 1 020990 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-
839s039ltr.pdf 2002-05-16 00:00:00
26416 1 020990 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se5-se5-
044,20990se5-010ltr.pdf 2003-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019839s055,020990s022l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s54175
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058,
019839s060, 020990s024, 020990s026ltr.pdf 2006-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019839s065,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019839s068,
20990s031ltr.pdf 2008-03-07 00:00:00
26426 1 020990 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,0
20990s033,s036,s037ltr.pdf 2011-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,0
20990s033,s036,s037ltr.pdf 2011-08-22 00:00:00
26428 1 020990 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,0
20990Orig1s034,s040ltr.pdf 2012-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20992ltr.htm
1999-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s016LTR.pdf
2002-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992se2-
021ltr.pdf 2004-03-03 00:00:00
26432 1 020992 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992slr024ltr.pdf
2004-02-02 00:00:00
26433 1 020992 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020992Orig1s034ltr.pdf
2015-03-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20998ltr.pdf
1998-12-31 00:00:00
26436 1 020998 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21156ltr.pdf
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998s009ltr.pdf
2002-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20998s10ltr.pdf
2001-10-18 00:00:00
26439 1 020998 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998scs013ltr.pdf
2002-08-29 00:00:00
26440 1 020998 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf
2005-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf
2005-08-03 00:00:00
26442 1 020998 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020998s021ltr.pdf
2006-12-28 00:00:00
26443 1 020998 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s022ltr.pdf
2007-06-07 00:00:00
26444 1 020998 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s023ltr.pdf
2007-11-08 00:00:00
26445 1 020998 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s026ltr.pdf
2008-01-18 00:00:00
26446 1 020998 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s027ltr.pdf
2009-01-06 00:00:00
26447 1 020998 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020998s033,021156s003l
tr.pdf 2011-02-09 00:00:00
26448 1 020998 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048lt
r.pdf 2016-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_Approv.pdf
2001-05-07 00:00:00
26450 1 021001 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21001slr002ltr.pdf
2004-06-07 00:00:00
26451 1 021001 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf
2009-04-01 00:00:00
26452 1 021003 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21004s2ltr.pdf
2001-08-16 00:00:00
26453 1 021003 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21003slr004,21004slr00
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26454 1 021003 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021003s010,
021004s010ltr.pdf 2007-10-04 00:00:00
26455 1 021004 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21003slr004,21004slr00
5ltr.pdf 2003-11-25 00:00:00
26456 1 021004 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021003s013,021004s013l
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26457 1 021004 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021003Orig1s015.021004
Orig1s015ltr.pdf 2013-12-24 00:00:00
26458 1 021005 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21005slr006ltr.pdf
2003-05-29 00:00:00
26459 1 021005 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005scs007ltr.pdf
2004-03-24 00:00:00
26460 1 021005 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021005s010ltr.pdf
2007-06-07 00:00:00
26461 1 021005 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021005s013ltr.pdf
2011-12-14 00:00:00
26462 1 021006 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010lt
r.pdf 2009-03-05 00:00:00
26463 1 021006 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010lt
r.pdf 2009-03-05 00:00:00
26464 1 021007 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf
2002-02-05 00:00:00
26465 1 021007 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr011and21039slr
010ltr.pdf 2002-08-02 00:00:00
26466 1 021007 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf
2002-02-05 00:00:00
26467 1 021007 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039s
lr013,014ltr.pdf 2002-10-02 00:00:00
26468 1 021008 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21008ltr.pdf
1998-11-25 00:00:00
26469 1 021008 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21008scs007ltr.pdf
2003-12-23 00:00:00
26470 1 021008 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008scs010ltr.pdf
2004-04-29 00:00:00
26471 1 021008 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf
2006-05-16 00:00:00
26472 1 021008 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf
2006-05-16 00:00:00
26473 1 021008 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021008s021ltr.pdf
2008-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023l
tr.pdf 2010-02-05 00:00:00
26475 1 021008 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021008Orig1s028ltr.pdf
2014-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21009ltr.pdf
1999-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003,
021009s004ltr.pdf 2007-08-22 00:00:00
26478 1 021009 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf
2004-10-22 00:00:00
26479 1 021009 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021009s010ltr.pdf
2008-07-08 00:00:00
26480 1 021011 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s002ltr.pdf
2009-02-24 00:00:00
26481 1 021011 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s003ltr.pdf
2009-05-20 00:00:00
26482 1 021012 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21012_Neotect_appltrs.pdf
1999-08-03 00:00:00
26483 1 021014 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21014ltr.pdf
1999-01-10 00:00:00
26484 1 021014 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s013,021285s008r
el2_ltr.pdf 2005-11-01 00:00:00
26485 1 021014 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s014ltr.pdf
2005-11-18 00:00:00
26486 1 021014 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s
024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 2011-03-08
00:00:00
26487 1 021014 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s
024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 2011-03-08
00:00:00
26488 1 021014 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021014s026,021285s021l
tr.pdf 2009-05-04 00:00:00
26489 1 021014 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s
024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 2011-03-08
00:00:00
26490 1 021014 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s031,021285s025l
tr.pdf 2011-11-14 00:00:00
26491 1 021015 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015slr008ltr.pdf
2003-09-29 00:00:00
26492 1 021015 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015scp010ltr.pdf
2003-09-30 00:00:00
26493 1 021015 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s019,s020ltr.pdf
2008-01-09 00:00:00
26494 1 021015 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s032ltr.pdf
2011-12-05 00:00:00
26495 1 021015 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021015Orig1s034ltr.pdf
2012-09-24 00:00:00
26496 1 021015 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021015Orig1s036ltr.pdf
2013-05-22 00:00:00
26497 1 021015 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s038ltr.pdf
2014-11-14 00:00:00
26498 1 021015 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021015Orig1s040ltr.pdf
2015-05-13 00:00:00
26499 1 021016 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21016ltr.pdf
2003-01-29 00:00:00
26500 1 021016 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21016slr003ltr.pdf
2004-05-07 00:00:00
26501 1 021016 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf
2010-07-23 00:00:00
26502 1 021016 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s
024,s027ltr.pdf 2013-10-08 00:00:00
26503 1 021016 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s
024,s027ltr.pdf 2013-10-08 00:00:00
26504 1 021017 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,
021018s041ltr.pdf 2020-03-23 00:00:00
26505 1 021017 SUPPL 108 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021017Orig1s108ltr.pdf
2020-03-23 00:00:00
26506 14 021018 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26507 14 021018 SUPPL 11 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26508 14 021018 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26509 14 021018 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26510 14 021018 SUPPL 35 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26511 14 021018 SUPPL 41 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26512 14 021018 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26513 14 021018 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26514 1 021019 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntl
bl.pdf 1999-10-06 00:00:00
26515 1 021022 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr002ltr.pdf
2003-06-22 00:00:00
26516 1 021022 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr003ltr.pdf
2003-12-24 00:00:00
26517 1 021022 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21022s004ltr.pdf
2004-12-08 00:00:00
26518 1 021024 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21024ltr.pdf
1998-06-22 00:00:00
26519 1 021024 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_Approv.pdf
2000-10-20 00:00:00
26520 1 021024 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s010ltr.pdf
2014-11-24 00:00:00
26521 1 021025 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr00
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26522 1 021025 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020823s016,
021025s008ltr.pdf 2006-07-03 00:00:00
26523 1 021025 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s
028,s029,021025Orig1s018,s019,s0020ltr.pdf 2013-10-04 00:00:00
26524 1 021027 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21027ltr.pdf
2000-04-06 00:00:00
26525 1 021027 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021027s012ltr.pdf
2005-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021027Orig1s026ltr.pdf
2016-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21029ltr.pdf
1999-08-11 00:00:00
26528 1 021029 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21029s4ltr.pdf
2002-01-18 00:00:00
26529 1 021029 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21029se8-
005ltr.pdf 2003-03-26 00:00:00
26530 1 021029 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029s006ltr.pdf
2004-07-21 00:00:00
26531 1 021029 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s009ltr.pdf
2005-03-31 00:00:00
26532 1 021029 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001l
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26533 1 021029 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021029Orig1s026ltr.pdf
2014-05-06 00:00:00
26534 1 021029 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s028ltr.pdf
2015-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021029Orig1s031ltr.pdf
2016-02-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s048ltr.pdf
2006-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s
083,s085,021505s019,s020,s025,s026ltr.pdf 2011-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054,
21505s009LTR.pdf 2006-08-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021035s057,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s
083,s085,021505s019,s020,s025,s026ltr.pdf 2011-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21036S1LTR.PDF
2000-04-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr005ltr.pdf
2004-06-15 00:00:00
26547 1 021036 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr006ltr.pdf
2003-08-15 00:00:00
26548 1 021036 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021036s007ltr.pdf
2009-10-16 00:00:00
26549 1 021036 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s008ltr.pdf
2006-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s012ltr.pdf
2007-09-11 00:00:00
26551 1 021036 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s014ltr.pdf
2009-10-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021036s018ltr.pdf
2009-10-16 00:00:00
26553 1 021036 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s019ltr.pdf
2010-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021036s027ltr.pdf
2011-12-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021037s014ltr.pdf
2006-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019596s045,021037s019l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019596s051,021037s025l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019596Orig1s056,021037
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021037Orig1s031ltr.pdf
2015-08-03 00:00:00
26560 1 021038 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021038s010ltr.pdf
2008-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s
026ltr.pdf 2014-12-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-
007SE7006_Agenerase_Approv.pdf 2001-05-11 00:00:00
26564 1 021039 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf
2002-02-05 00:00:00
26565 1 021039 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr011and21039slr
010ltr.pdf 2002-08-02 00:00:00
26566 1 021039 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021039s017ltr.pdf
2005-11-18 00:00:00
26568 1 021040 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21040s012ltr.pdf
2004-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21041ltr.pdf
1999-04-01 00:00:00
26572 1 021041 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21041scp008,010ltr.pdf
2003-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021041s018_LTR.pdf
2007-04-25 00:00:00
26574 1 021041 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021041s023ltr.pdf
2011-08-16 00:00:00
26575 1 021042 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14l
tr.pdf 2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14l
tr.pdf 2002-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21
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26579 1 021042 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21
042slr020,021,022ltr.pdf 2003-07-06 00:00:00
26580 1 021042 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042slr023ltr.pdf
2003-12-19 00:00:00
26581 1 021042 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr017,21042slr02
4ltr.pdf 2003-12-19 00:00:00
26582 1 021042 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21042s028,21052s021ltr
.pdf 2004-09-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21043ltr.pdf
2000-03-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21043s005ltr.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21044ltr.pdf
2004-09-27 00:00:00
26586 1 021044 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021044Orig1s013ltr.pdf
2014-04-17 00:00:00
26587 1 021045 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-045_Plan
%20B_Approv.pdf 1999-07-28 00:00:00
26588 1 021046 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21046ltr.pdf
1999-12-22 00:00:00
26589 1 021046 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034,
021046s013, 021323s025, 021365s016ltr.pdf 2007-08-07 00:00:00
26590 1 021046 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,
ltr.pdf 2008-09-19 00:00:00
26591 1 021046 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,
021323s032,021365s023ltr.pdf 2009-02-03 00:00:00
26592 14 021047 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26593 1 021048 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21048ltr.pdf
1999-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_vioxx_appltr.pdf
1999-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21
042slr020,021,022ltr.pdf 2003-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr017,21042slr02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21052s019,026ltr.pdf
2004-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21055slr002,003ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021055s008ltr.pdf
2012-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021055Orig1s010ltr.pdf
2015-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021060s001ltr.pdf
2005-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021060s003_LTR.pdf
2007-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021060s006ltr.pdf
2011-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
064_Definity_Approv.pdf 2001-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064s1ltr.pdf
2002-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021064s011ltr.pdf
2011-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021064Orig1s017ltr.pdf
2015-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21065slr009ltr.pdf
2004-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21065s012ltr.pdf
2005-01-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21066ltr.pdf
1999-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021066s011ltr.pdf
2006-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021066s013ltr.pdf
2008-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021066s018ltr.pdf
2012-05-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21067ltr.pdf
2005-03-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s003ltr.pdf
2010-09-02 00:00:00
26619 1 021067 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021067s013ltr.pdf
2010-09-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21068ltr.pdf
1998-11-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf
2002-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21071ltr.pdf
1999-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21071S1LTR.PDF
2000-04-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21071se1-
004ltr.pdf 2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s012ltr.pdf
2005-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s015ltr.pdf
2005-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s023ltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s026ltr.pdf
2008-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s028LTR.pdf
2007-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s032ltr.pdf
2008-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s034ltr.pdf
2008-10-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,
021700s011ltr.pdf 2011-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s
049ltr.pdf 2014-05-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s
049ltr.pdf 2014-05-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21073ltr.pdf
1999-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-
017ltr.pdf 2003-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073slr071ltr.pdf
2003-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s026ltr.pdf
2007-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s030_ltr.pdf
2007-09-11 00:00:00
26644 1 021073 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s034ltr.pdf
2008-12-18 00:00:00
26645 1 021073 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-
021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 2011-08-05
00:00:00
26646 1 021073 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,
022024s009,021925s012ltr.pdf 2012-05-22 00:00:00
26647 1 021074 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021074Orig1s010ltr.pdf
2015-11-16 00:00:00
26648 1 021076 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021076s011ltr.pdf
2006-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021076s013ltr.pdf
2008-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021076s014ltr.pdf
2009-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077se5-
017ltr.pdf 2004-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077slr019ltr.pdf
2003-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20
692s026ltr.pdf 2004-10-04 00:00:00
26655 1 021077 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028,
021077s027ltr.pdf 2007-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029l
tr.pdf 2006-03-23 00:00:00
26657 1 021077 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021077029ltr.pdf
2008-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,
020692s038ltr.pdf 2011-05-12 00:00:00
26659 1 021077 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254
Orig1s019,020692Orig1s042ltr.pdf 2012-08-13 00:00:00
26660 1 021077 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s051ltr.pdf
2014-04-16 00:00:00
26661 1 021078 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078s001ltr.pdf
2002-02-28 00:00:00
26662 1 021078 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s002ltr.pdf
2004-09-07 00:00:00
26663 1 021078 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078se8-
003ltr.pdf 2002-08-02 00:00:00
26664 1 021078 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21078se5-
006ltr.pdf 2003-12-08 00:00:00
26665 1 021078 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s007ltr.pdf
2004-12-02 00:00:00
26666 1 021078 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf
2005-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s014ltr.pdf
2008-05-09 00:00:00
26668 1 021078 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021078s017ltr.pdf
2009-11-09 00:00:00
26669 1 021079 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf
2005-05-17 00:00:00
26670 1 021079 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf 2020-
03-23 00:00:00
26672 14 021081 SUPPL 5 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26673 14 021081 SUPPL 11 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26674 14 021081 SUPPL 14 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26675 14 021081 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26676 14 021081 SUPPL 55 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26677 14 021081 SUPPL 57 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26678 14 021081 SUPPL 62 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26679 14 021081 SUPPL 63 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26680 1 021083 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21083A_Rapamune_appltr.pdf
1999-09-15 00:00:00
26681 1 021083 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,211
10slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00
26682 1 021083 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,211
10slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00
26683 1 021083 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,211
10slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00
26684 1 021083 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,211
10slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00
26685 1 021083 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr015,21110slr01
5ltr.pdf 2003-10-09 00:00:00
26686 1 021083 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21083s017,21110s020ltr
.pdf 2004-07-21 00:00:00
26687 1 021083 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21083s019,21110s024ltr
.pdf 2005-03-14 00:00:00
26688 1 021083 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s
027,028ltr.pdf 2005-07-08 00:00:00
26689 1 021083 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s
030,031ltr.pdf 2005-10-14 00:00:00
26690 1 021083 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024,
s025, 021110s032, s034LTR.pdf 2006-06-06 00:00:00
26691 1 021083 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s033,021110s043_
CKD.pdf 2008-01-18 00:00:00
26692 1 021083 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036,
s037, 021110s047, s048ltr.pdf 2008-03-10 00:00:00
26693 1 021083 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s040,021110s050l
tr.pdf 2009-11-10 00:00:00
26694 1 021083 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s
053,s054ltr.pdf 2010-04-28 00:00:00
26695 1 021083 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s
053,s054ltr.pdf 2010-04-28 00:00:00
26696 1 021083 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s045,021110s052l
tr.pdf 2010-02-01 00:00:00
26697 1 021083 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s048,021110s058l
tr.pdf 2010-11-08 00:00:00
26698 1 021083 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021083Orig1s051,021110
Orig1s065ltr.pdf 2012-12-11 00:00:00
26699 1 021084 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21084ltr.pdf
2000-02-17 00:00:00
26700 1 021085 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21085ltr.pdf
1999-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf
2002-06-12 00:00:00
26702 1 021085 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
085S010_Avelox_Approv.pdf 2001-04-27 00:00:00
26703 1 021085 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-
085s012ltr.pdf 2002-05-16 00:00:00
26704 1 021085 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-
015slr017,21277slr006se1-007slr009ltr.pdf 2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-
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26706 1 021085 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21277slr011,21085slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s039,
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26708 1 021085 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s042,021277s036l
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26709 1 021085 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s045,021277s039l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s052,021277s049l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s056,021277
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021277Orig1s054,021085
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021085Orig1s059,021277
Orig1s055ltr.pdf 2014-11-24 00:00:00
26715 1 021085 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021085Origs060,021277O
rig1s056ltr.pdf 2015-05-13 00:00:00
26716 1 021085 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021277Orig1s059,21085O
rig1s063ltr.pdf 2016-07-26 00:00:00
26717 1 021086 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,
021253s015ltr.pdf 2005-09-15 00:00:00
26718 1 021086 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038,
021086s020, 021253s021ltr.pdf 2006-12-28 00:00:00
26719 1 021086 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s
022s023_021253s026_ltr.pdf 2007-07-10 00:00:00
26720 1 021086 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086
Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf 2014-12-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21087LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf
2002-04-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s015ltr.pdf
2009-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr01
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s017ltr.pdf
2009-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s034ltr.pdf
2009-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s036ltr.pdf
2009-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s043ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21088ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21088slr015ltr.pdf
2003-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s022ltr.pdf
2005-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021088s025ltr.pdf
2011-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21090slr003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21093ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021093s006LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21097s005ltr.pdf
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2005-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021097s010ltr.pdf
2006-04-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s014,021892s004l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021140s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021140s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21142s3ltr.pdf
2002-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142slr009ltr.pdf
2003-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142scs010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021142s012ltr.pdf
2006-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf
2005-02-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021144s004ltr.pdf
2005-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s005ltr.pdf
2005-04-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf
2010-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21145ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine
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March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26901 14 021148 SUPPL 18 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26902 14 021148 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26903 14 021148 SUPPL 25 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26904 14 021148 SUPPL 39 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26905 14 021148 SUPPL 41 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26906 14 021148 SUPPL 44 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21149slr006ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21150ltr.pdf
2001-08-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/21150s007ltr.pdf
2007-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs004ltr.pdf
2003-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021152ltr.pdf
2005-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium_Approv.pdf
2001-02-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21153slr004ltr.pdf
2003-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153s019ltr.pdf
2004-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s021ltr.pdf
2006-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s022LTR.pdf
2006-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21156scf001scp002ltr.p
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021158s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21159ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021159s009LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21162ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21162scm005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021162s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021162Orig1s032ltr.pdf
2016-01-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021162Orig1s037ltr.pdf
2014-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21163ltr.pdf
2000-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21163slr005ltr.pdf
2004-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021163s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21165s1ltr.pdf
2002-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21166s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021166s007ltr.pdf
2008-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021166Orig1s010ltr.pdf
2014-03-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf
2000-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21168s001ltr.pdf
2002-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021168s009ltr.pdf
2006-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021168s015ltr.pdf
2008-03-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082
Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf
2014-11-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,010808
2Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf
2015-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082
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2016-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21169s003.pdf
2002-05-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,
021615s002ltr.pdf 2005-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,212
24s8s10s11s12,21615s1s3s4s5LTR.pdf 2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,212
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,
021615s018ltr.pdf 2012-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169O
rig1s30,021224Orig1s28ltr.pdf 2015-02-12 00:00:00
26975 14 021172 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26976 14 021172 SUPPL 9 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26977 14 021172 SUPPL 13 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26978 14 021172 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26979 14 021172 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26980 14 021172 SUPPL 38 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26981 14 021172 SUPPL 39 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26982 14 021172 SUPPL 43 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26983 14 021172 SUPPL 44 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26984 14 021172 SUPPL 45 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26985 14 021172 SUPPL 46 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26986 14 021172 SUPPL 63 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
26987 14 021172 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_approv.pdf
2002-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs008ltr.pdf
2003-08-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s015LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021176s019ltr.pdf
2007-08-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,0
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21178se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21178se5-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021178s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21179ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20926se1-
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021179s015ltr.pdf
2005-07-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s020ltr.pdf
2007-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_Ortho
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s020LTR.pdf
2006-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s022ltr.pdf
2006-09-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028,%20s030,%20
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s038ltr.pdf
2011-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s039ltr.pdf
2011-03-25 00:00:00
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Orig1s044,021630Orig1s027ltr.pdf 2014-04-08 00:00:00
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lr005,006,21630slr001ltr.pdf 2004-04-29 00:00:00
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630s003ltr.pdf 2004-12-29 00:00:00
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630s004ltr.pdf 2005-03-29 00:00:00
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021267s011ltr.pdf 2005-07-15 00:00:00
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021267s021, 021630s011ltr.pdf 2006-12-28 00:00:00
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021267s024, 021630s013ltr.pdf 2008-03-13 00:00:00
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021267s026, 021630s015ltr.pdf 2008-06-03 00:00:00
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00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20451s012ltr.pdf
2004-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021526s002ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021526s012ltr.pdf
2010-09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s026ltr.pdf
2013-12-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021526Orig1s028ltr.pdf
2015-12-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021526Orig1s029ltr.pdf
2016-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527S003ltr.pdf
2006-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021527s011ltr.pdf
2008-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021527s019ltr.pdf
2011-10-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021529s000_ltr.pdf
2006-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021529Orig1s010ltr.pdf
2013-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021529Orig1s013ltr.pdf
2016-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21530ltr.pdf
2004-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s
001,003ltr.pdf 2005-08-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020938s018,
021530s006ltr.pdf 2008-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007l
tr.pdf 2010-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,0
21530Origs014,s015ltr.pdf 2016-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21532ltr.pdf
2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021532s004ltr.pdf
2005-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021532Orig1s015ltr.pdf
2016-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s020ltr.pdf
2012-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s024ltr.pdf
2014-06-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21535ltr.pdf
2003-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s002ltr.pdf
2012-08-20 00:00:00
28049 14 021536 SUPPL 20 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28050 14 021536 SUPPL 21 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28051 14 021536 SUPPL 24 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28052 14 021536 SUPPL 29 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28053 14 021536 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28054 14 021536 SUPPL 33 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28055 14 021536 SUPPL 48 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28056 14 021536 SUPPL 50 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21537ltr.pdf
2003-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021537Orig1s012ltr.pdf
2015-12-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr001ltr.pdf
2004-04-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr002ltr.pdf
2004-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021539Orig1s012ltr.pdf
2013-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540ltr.pdf
2004-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540s003ltr.pdf
2004-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021540s006ltr.pdf
2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021540s008ltr.pdf
2006-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021540s009ltr.pdf
2007-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021540s011ltr.pdf
2007-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021540s014ltr.pdf
2008-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021540s018ltr.pdf
2009-11-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021540s019ltr.pdf
2010-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s023,s026lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s023,s026lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021540Orig1s034ltr.pdf
2014-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021540Orig1s037ltr.pdf
2015-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21543s002ltr.pdf
2004-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021543Orig1s010ltr.pdf
2014-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021543Orig1s011ltr.pdf
2015-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21544ltr.pdf
2003-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s006ltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021545s013ltr.pdf
2010-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s050,021546
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s052,021546
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021548s004ltr.pdf
2005-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s008ltr.pdf
2006-05-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s010ltr.pdf
2007-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s017,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s019,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s021_022116s005l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021548s026,022116s010l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s028,022116s012l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021548Orig1s031,022116
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021548Orig1s037,022116
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s007ltr.pdf
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2006-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021549s012ltr.pdf
2007-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s014ltr.pdf
2009-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021549s015ltr.pdf
2008-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021549Orig1s021ltr.pdf
2012-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021551s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021555s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021555s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021566s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s039ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021572Orig1s043,021572
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s038,021575s007.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s069,021575
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021583ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021583s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021585s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021586Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21587ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21588s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s006ltr.pdf
2005-05-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s016ltr.pdf
2006-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021588s020ltr.pdf
2007-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s027ltr.pdf
2009-02-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf
2011-04-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021588Orig1s042ltr.pdf
2015-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21589ltr.pdf
2003-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590slr001ltr.pdf
2004-06-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590s002ltr.pdf
2004-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s008ltr.pdf
2005-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s015,s016ltr.pdf
2010-07-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s017ltr.pdf
2010-09-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s018ltr.pdf
2010-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021590Orig1s021ltr.pdf
2013-07-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021590s024ltr.pdf
2012-01-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479
Orig1s009ltr.pdf 2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021591s003ltr.pdf
2005-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021591s005ltr.pdf
2010-12-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021592s000ltr.pdf
2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21594ltr.pdf
2004-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21595s001ltr.pdf
2005-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021595s002_ltr.pdf
2006-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021595s003ltr.pdf
2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021595s006ltr.pdf
2011-09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021595s007ltr.pdf
2011-02-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021595Orig1s008,s009lt
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28221 14 021597 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598ltr.pdf
2003-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr002ltr.pdf
2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr008ltr.pdf
2004-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021602s007ltr.pdf
2005-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021602s008,
s009LTR.pdf 2006-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s019s020ltr.pdf
2010-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021602s023ltr.pdf
2010-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602s027ltr.pdf
2012-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021602s029,s030ltr.pdf
2011-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602Orig1s031,s032lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s040ltr.pdf
2014-10-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021602Orig1s042ltr.pdf
2015-09-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021604s003ltr.pdf
2006-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021604Orig1s004ltr.pdf
2014-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021606ltr.pdf
2005-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021606Orig1s012,s014lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021610s003ltr.pdf
2007-07-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021610s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021610Orig1s013ltr.pdf
2012-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021610Orig1s014ltr.pdf
2013-04-18 00:00:00
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2016-04-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002,
s004ltr.pdf 2008-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021615s000revLTR.pdf
2004-12-29 00:00:00
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24s8s10s11s12,21615s1s3s4s5LTR.pdf 2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,
021615s009ltr.pdf 2012-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224
Orig1s022,021615Orig1s016ltr.pdf 2013-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,
021615s018ltr.pdf 2012-03-05 00:00:00
28252 1 021615 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169O
rig1s30,021224Orig1s28ltr.pdf 2015-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21620ltr.pdf
2004-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021,
021585s012, 021620s011_ltr.pdf 2007-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s035,021620
Orig1s029ltr.pdf 2014-03-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021623ltr.pdf
2005-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017lt
r.pdf 2014-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017lt
r.pdf 2014-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21626scp001ltr.pdf
2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021626s007ltr.pdf
2008-08-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001L
TR.pdf 2006-10-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s
014,021627Orig1s008ltr.pdf 2013-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021627Orig1s012ltr.pdf
2014-08-12 00:00:00
28264 14 021629 SUPPL 10 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28265 14 021629 SUPPL 28 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28266 14 021629 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,
021267s011ltr.pdf 2005-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,
021630s006ltr.pdf 2006-01-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021630s009ltr.pdf
2008-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,
021630s010LTR .pdf 2006-05-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023,
021267s024, 021630s013ltr.pdf 2008-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s
030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf 2010-06-24
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026,
021267s026, 021630s015ltr.pdf 2008-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s
030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf 2010-06-24
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,
021630s022ltr.pdf 2010-12-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,
021630s023ltr.pdf 2010-11-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,
021630s024ltr.pdf 2011-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267
Orig1s044,021630Orig1s027ltr.pdf 2014-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021632s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021632s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021644Orig1s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21647ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s005ltr.pdf
2011-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021648Orig1s008ltr.pdf
2015-07-29 00:00:00
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2004-08-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021652s005ltr.pdf
2007-05-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s018ltr.pdf
2015-02-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21654ltr.pdf
2004-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021654s007LTR.pdf
2006-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s015ltr.pdf
2008-01-09 00:00:00
28318 1 021654 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s023ltr.pdf
2009-04-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021654Orig1s034ltr.pdf
2012-09-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21656ltr.pdf
2004-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021656s020ltr.pdf
2011-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021656Orig1s023ltr.pdf
2013-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s005ltr.pdf
2012-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s036ltr.pdf
2013-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s037ltr.pdf
2013-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021660Orig1s041ltr.pdf
2015-07-22 00:00:00
28330 14 021663 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
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28331 14 021663 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021664s001ltr.pdf
2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021664s010ltr.pdf
2009-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21665ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021667s003ltr.pdf
2011-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s002ltr.pdf
2006-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s003LTR.pdf
2006-08-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021670ltr.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21671ltr.pdf
2004-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21671s002ltr.pdf
2004-08-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021671s014ltr.pdf
2007-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021673ltr.pdf
2004-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf
2008-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021673s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021673Orig1s022ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021676s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21677,21462s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21684ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21687ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s001ltr.pdf
2005-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21687s002ltr.pdf
2005-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s006,s013ltr.pdf
2006-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s011LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s016ltr.pdf
2006-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021687s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021687s022ltr.pdf
2008-02-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s029ltr.pdf
2009-01-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s032ltr.pdf
2010-01-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s034ltr.pdf
2010-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s037ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s033,s040ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s041ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s042ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687Orig1s046,s047lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021687Orig1s050ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021687Orig1s053ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021688s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021688s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s007ltr.pdf
2006-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021689s012,021689s013l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s014ltr.pdf
2014-03-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s025ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s026ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021692s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021695s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021698s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021822s000ltr.pdf
2008-06-26 00:00:00
28664 1 021823 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002l
tr.pdf 2006-01-30 00:00:00
28665 1 021823 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021823Orig1s009ltr.pdf
2013-04-24 00:00:00
28666 1 021823 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s011ltr.pdf
2015-04-13 00:00:00
28667 1 021825 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021825Orig1s000ltr.pdf
2011-10-14 00:00:00
28668 1 021829 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021829s000ltr.pdf
2007-05-16 00:00:00
28669 1 021829 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf
2012-04-04 00:00:00
28670 1 021829 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021829Orig1s007ltr.pdf
2015-02-27 00:00:00
28671 1 021830 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021830s000ltr.pdf
2008-06-03 00:00:00
28672 1 021830 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021830s002ltr.pdf
2009-04-27 00:00:00
28673 1 021830 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021830s005ltr.pdf
2010-05-28 00:00:00
28674 1 021830 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021830Orig1s006ltr.pdf
2013-10-21 00:00:00
28675 1 021835 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021835ltr.pdf
2005-11-01 00:00:00
28676 1 021835 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf
2011-01-14 00:00:00
28677 1 021835 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s006ltr.pdf
2012-09-10 00:00:00
28678 1 021835 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s007ltr.pdf
2012-08-20 00:00:00
28679 1 021837 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021837s000,022177s000l
tr.pdf 2008-03-24 00:00:00
28680 1 021838 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021838s000TAltr.pdf
2007-03-15 00:00:00
28681 14 021839 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28682 14 021839 SUPPL 10 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28683 14 021839 SUPPL 12 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28684 14 021839 SUPPL 16 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28685 1 021840 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021840s008ltr.pdf
2010-08-09 00:00:00
28687 1 021842 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021842ltr.pdf
2005-08-31 00:00:00
28688 1 021842 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021842s001ltr.pdf
2006-09-18 00:00:00
28689 1 021842 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029,
021842s003LTR.pdf 2006-10-02 00:00:00
28690 1 021842 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021842s005ltr.pdf
2007-10-04 00:00:00
28691 1 021842 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s007ltr.pdf
2009-01-06 00:00:00
28692 1 021842 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010l
tr.pdf 2012-05-18 00:00:00
28693 1 021842 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s009ltr.pdf
2009-10-26 00:00:00
28694 1 021842 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021842s012ltr.pdf
2010-08-11 00:00:00
28695 1 021842 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-
021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 2011-08-04
00:00:00
28696 1 021842 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,
022024s009,021925s012ltr.pdf 2012-05-22 00:00:00
28697 1 021844 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021844s000ltr.pdf
2006-10-23 00:00:00
28698 1 021845 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845s001ltr.pdf
2005-11-18 00:00:00
28699 1 021845 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s002ltr.pdf
2006-08-04 00:00:00
28700 1 021845 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s005ltr.pdf
2009-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473
Orig1s004,203109Origs002ltr.pdf 2014-03-13 00:00:00
28702 1 021845 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;02
2473Orig1s005,006;203109Orig1s003,004ltr.pdf 2014-02-04 00:00:00
28703 1 021845 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473
Orig1s007,203109Orig1s005ltr.pdf 2014-03-07 00:00:00
28704 14 021846 SUPPL 101 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
28705 1 021849 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021849s002ltr.pdf
2008-01-09 00:00:00
28706 1 021849 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005l
tr.pdf 2011-05-25 00:00:00
28707 1 021849 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006l
tr.pdf 2011-12-13 00:00:00
28708 1 021849 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008l
tr.pdf 2012-04-23 00:00:00
28709 1 021849 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849
Orig1s009ltr.pdf 2014-03-04 00:00:00
28710 1 021850 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,
021850s003,022456s002ltr.pdf 2010-09-08 00:00:00
28711 1 021852 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021852s000ltr.pdf
2006-01-20 00:00:00
28712 1 021852 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021852s002ltr.pdf
2007-10-04 00:00:00
28713 1 021852 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021852Orig1s012ltr.pdf
2012-12-04 00:00:00
28714 1 021854 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021854s000ltr.pdf
2007-03-15 00:00:00
28715 1 021856 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021856s000ltr.pdf
2009-02-18 00:00:00
28716 1 021856 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021856Orig1s006ltr.pdf
2012-11-06 00:00:00
28717 1 021858 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s
014ltr.pdf 2013-04-24 00:00:00
28718 1 021858 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s009ltr.pdf
2011-01-27 00:00:00
28719 1 021858 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s010ltr.pdf
2011-08-12 00:00:00
28720 1 021858 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s012ltr.pdf
2011-07-07 00:00:00
28721 1 021858 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s
014ltr.pdf 2013-04-24 00:00:00
28722 1 021859 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021859s002LTR.pdf
2020-03-23 00:00:00
28723 1 021859 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021859s005ltr.pdf
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28724 1 021860 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s001ltr.pdf
2007-04-09 00:00:00
28725 1 021860 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s002ltr.pdf
2007-12-03 00:00:00
28726 1 021860 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021860s005ltr.pdf
2009-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s
008,s009ltr.pdf 2013-07-08 00:00:00
28728 1 021860 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s
008,s009ltr.pdf 2013-07-08 00:00:00
28729 1 021860 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s
008,s009ltr.pdf 2013-07-08 00:00:00
28730 1 021861 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021861s002ltr.pdf
2010-01-26 00:00:00
28731 1 021861 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021861s008ltr.pdf
2010-04-05 00:00:00
28732 1 021866 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,
021729s002,021866s3s2ltr.pdf 2007-10-04 00:00:00
28733 1 021866 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,
021729s002,021866s3s2ltr.pdf 2010-02-14 00:00:00
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021866s005, 021729s005, 021713s013ltr.pdf 2007-11-19 00:00:00
28735 1 021866 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-
006,021866se1-007,021866s009ltr.pdf 2008-05-14 00:00:00
28736 1 021866 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-
006,021866se1-007,021866s009ltr.pdf 2008-05-14 00:00:00
28737 1 021866 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,
021729s010,021866s010ltr.pdf 2008-03-07 00:00:00
28738 1 021866 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,
021729s012,021866s013ltr.pdf 2008-08-19 00:00:00
28739 1 021866 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,
021729s013,021866s014ltr.pdf 2009-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021866s015ltr.pdf
2010-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,
021713s023,021729s016ltr.pdf 2010-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,2
1713s024,21729s017ltr.pdf 2011-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,
021713s025,021729s018ltr.pdf 2012-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021870s005ltr.pdf
2011-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021870s007ltr.pdf
2012-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021872Orig1s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf
2009-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021876Orig1s006ltr.pdf
2014-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf
2009-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021877s005ltr.pdf
2012-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021878ltr.pdf
2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021879s000ltr.pdf
2010-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021880rev2.pdf
2006-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021880s001LTR.pdf
2006-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,
021880s017ltr.pdf 2009-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,
021880s017ltr.pdf 2009-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s018ltr.pdf
2010-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s031ltr.pdf
2012-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s034ltr.pdf
2013-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040lt
r.pdf 2014-09-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s041ltr.pdf
2015-02-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s046ltr.pdf
2015-12-02 00:00:00
28772 1 021881 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021881s003ltr.pdf
2008-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s015ltr.pdf
2013-09-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s016ltr.pdf
2013-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021882ltr.pdf
2005-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s002lltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s003ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021882s010ltr.pdf
2010-02-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s011ltr.pdf
2011-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021882Orig1s014ltr.pdf
2012-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s017ltr.pdf
2013-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021883Orig1s002ltr.pdf
2015-12-22 00:00:00
28784 1 021883 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021883Orig1s003ltr.pdf
2016-01-21 00:00:00
28785 14 021884 SUPPL 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021887s002ltr.pdf
2010-09-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021887Orig1s006ltr.pdf
2014-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022148s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022150s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022150Orig1s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s003,s004lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022154s003,022011s006l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s009,022154s006l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s011,022154s008l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s012,022154s009l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022156s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022064Orig1s024,022157
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s030,022157
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022159Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022161s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr_cor
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022165s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022165s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022173s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022173Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022173Orig1s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022180s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022180s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022181s000_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022181Orig1s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022181Orig1s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022184s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022184Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022185s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022185s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022186s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022187s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022187s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022187s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022192Orig1s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022195Orig1s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022196S000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022196s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022196s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022198s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022198Orig1s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022198Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022202s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003s,s004ltr.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022203s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022203s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022204s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022204Orig1s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022206s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022206s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022212Orig1s016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022214s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022217s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022217s020ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022224s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022225Orig1s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022311Orig1s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022314s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990s017,022314s012l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314Orig1s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022321s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022334s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,02
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s027ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s038ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022341s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022341Orig1s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341Orig1s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s018ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022341Orig1s021ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s024ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022345s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022345s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022345Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022348s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022348Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022350s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022352s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022352s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022352Orig1s017ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022359s000TAltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022360s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363s008,s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022363Orig1s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022369s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022372s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022382s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022382Orig1s009ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022382Orig1s012,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022386s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022387s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022387Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022393Orig1s013ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022395s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s003ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022401s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022401s002ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s004ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022405Orig1s007ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022405Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022416Orig1s001ltr.pdf
2015-09-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s050,022417s001l
tr.pdf 2010-05-03 00:00:00
29704 1 022417 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020659Orig1s062,022417
Orig1s14ltr.pdf 2015-11-17 00:00:00
29705 1 022418 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s007ltr.pdf
2012-03-19 00:00:00
29706 1 022418 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022418Orig1s010ltr.pdf
2013-03-19 00:00:00
29707 1 022420 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022420s000ltr.pdf
2010-03-10 00:00:00
29708 1 022421 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022421Orig1s003ltr.pdf
2014-05-09 00:00:00
29709 1 022421 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022421Orig1s007ltr.pdf
2013-03-04 00:00:00
29710 1 022425 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022425s000ltr.pdf
2009-07-30 00:00:00
29711 1 022425 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s001ltr.pdf
2011-02-15 00:00:00
29712 1 022425 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s002ltr.pdf
2012-01-30 00:00:00
29713 1 022425 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s004ltr.pdf
2011-02-04 00:00:00
29714 1 022425 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s005ltr.pdf
2011-02-15 00:00:00
29715 1 022425 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s007ltr.pdf
2011-03-14 00:00:00
29716 1 022425 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s013ltr.pdf
2011-12-21 00:00:00
29717 1 022425 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s014ltr.pdf
2012-06-15 00:00:00
29718 1 022425 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s
018ltr.pdf 2012-09-10 00:00:00
29719 1 022425 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s
018ltr.pdf 2012-09-10 00:00:00
29720 1 022426 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022426Orig1s000Ltr_1_.
pdf 2013-02-12 00:00:00
29721 1 022426 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426
Orig1s005,203414Orig1s005ltr.pdf 2015-09-01 00:00:00
29722 1 022427 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022427s001ltr.pdf
2010-07-01 00:00:00
29723 1 022427 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022427Orig1s003ltr.pdf
2012-11-16 00:00:00
29724 1 022428 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022428s001ltr.pdf
2011-10-20 00:00:00
29725 1 022429 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022429Orig1s009ltr.pdf
2013-02-07 00:00:00
29726 1 022430 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s004ltr.pdf
2013-10-04 00:00:00
29727 1 022432 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022432s000ltr.pdf
2010-10-20 00:00:00
29728 1 022433 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s008ltr.pdf
2013-04-01 00:00:00
29729 1 022434 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022434Orig1s010ltr.pdf
2016-05-27 00:00:00
29730 1 022437 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,
022437s002ltr.pdf 2011-01-20 00:00:00
29731 1 022437 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s025,021288s022,
022437s003ltr.pdf 2011-05-24 00:00:00
29732 1 022437 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288
Orig1s027,022437Orig1s007ltr.pdf 2013-03-15 00:00:00
29733 1 022439 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022439s000ltr.pdf
2011-06-13 00:00:00
29734 1 022442 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022442s000ltr.pdf
2011-06-13 00:00:00
29735 1 022450 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022450s000ltr.pdf
2010-11-08 00:00:00
29736 1 022450 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006lt
r.pdf 2013-10-21 00:00:00
29737 1 022453 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022453Orig1s007ltr.pdf
2016-01-29 00:00:00
29738 1 022454 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022454s000ltr.pdf
2011-01-20 00:00:00
29739 1 022454 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022454Orig1s004ltr.pdf
2015-09-11 00:00:00
29740 1 022456 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022456s000ltr.pdf
2010-01-07 00:00:00
29741 1 022456 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,
021850s003,022456s002ltr.pdf 2010-09-08 00:00:00
29742 1 022456 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022456s003ltr.pdf
2011-05-25 00:00:00
29743 1 022456 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456Orig1s005ltr.pdf
2012-12-13 00:00:00
29744 1 022456 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456s006ltr.pdf
2012-05-24 00:00:00
29745 14 022458 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29746 1 022459 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022459s000TAltr.pdf
2010-03-22 00:00:00
29747 1 022460 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000TAltr.pdf
2010-03-22 00:00:00
29748 1 022460 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s
005ltr.pdf 2013-04-30 00:00:00
29749 1 022460 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s
005ltr.pdf 2013-04-30 00:00:00
29750 1 022462 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022462s000ltr.pdf
2010-11-29 00:00:00
29751 1 022464 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022464s000ltr.pdf
2010-01-05 00:00:00
29752 1 022465 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf
2012-05-02 00:00:00
29753 1 022465 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s
016ltr.pdf 2013-08-16 00:00:00
29754 1 022465 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s
016ltr.pdf 2013-08-16 00:00:00
29755 1 022465 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s018ltr.pdf
2014-06-05 00:00:00
29756 1 022465 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s021ltr.pdf
2015-09-24 00:00:00
29757 1 022465 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s022ltr.pdf
2016-05-24 00:00:00
29758 1 022468 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022468s000ltr.pdf
2009-09-29 00:00:00
29759 1 022468 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005lt
r.pdf 2011-01-14 00:00:00
29760 1 022468 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s009ltr.pdf
2012-02-17 00:00:00
29761 1 022468 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf
2012-06-04 00:00:00
29762 1 022468 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022468Orig1s012ltr.pdf
2016-05-16 00:00:00
29763 1 022470 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022470s000ltr.pdf
2009-12-02 00:00:00
29764 1 022472 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdf
2020-03-23 00:00:00
29765 14 022472 SUPPL 8 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29766 1 022473 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001l
tr.pdf 2010-11-22 00:00:00
29767 1 022473 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473
Orig1s010,203109Origs009ltr.pdf 2015-04-29 00:00:00
29768 1 022474 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s005ltr.pdf
2014-09-03 00:00:00
29769 1 022479 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022479s000TAltr.pdf
2010-05-21 00:00:00
29770 1 022483 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022483s006ltr.pdf
2012-02-17 00:00:00
29771 1 022485 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000ltr.pdf
2011-01-19 00:00:00
29772 1 022485 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022485Orig1s009ltr.pdf
2016-05-27 00:00:00
29773 1 022488 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022488s000,021446s018l
tr.pdf 2010-01-06 00:00:00
29774 1 022488 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488
s001,s002,s003ltr.pdf 2011-04-29 00:00:00
29775 1 022488 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488
s001,s002,s003ltr.pdf 2011-04-29 00:00:00
29776 1 022488 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s025,022488s004l
tr.pdf 2011-08-26 00:00:00
29777 1 022488 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s026,022488s005l
tr.pdf 2011-06-29 00:00:00
29778 1 022488 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s008;021446
Orig1s029ltr.pdf 2013-12-26 00:00:00
29779 1 022488 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s030,022488
Orig1s010ltr.pdf 2016-03-11 00:00:00
29780 1 022494 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022494s000ltr.pdf
2011-02-03 00:00:00
29781 1 022497 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022497s000ltr.pdf
2011-11-17 00:00:00
29782 1 022497 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022497Orig1s002ltr.pdf
2014-07-21 00:00:00
29783 1 022499 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022499s000,022500s000l
tr.pdf 2009-12-11 00:00:00
29784 1 022499 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022499s001,022500s001l
tr.pdf 2010-09-29 00:00:00
29785 1 022500 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022499s001,022500s001l
tr.pdf 2010-09-29 00:00:00
29786 1 022501 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022501s000ltr.pdf
2010-10-26 00:00:00
29787 1 022502 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022502Orig1s003ltr.pdf
2013-04-23 00:00:00
29788 1 022503 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022503Orig1s000ltr.pdf
2015-06-09 00:00:00
29789 1 022504 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022504s000ltr.pdf
2010-11-29 00:00:00
29790 1 022504 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s002ltr.pdf
2011-04-04 00:00:00
29791 1 022504 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s005ltr.pdf
2011-12-28 00:00:00
29792 1 022504 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022504Orig1s012ltr.pdf
2015-05-13 00:00:00
29793 14 022505 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29794 1 022509 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022509s000ltr.pdf
2010-02-17 00:00:00
29795 1 022510 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s000ltr.pdf
2011-01-14 00:00:00
29796 1 022510 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022510s005ltr.pdf
2012-06-07 00:00:00
29797 1 022511 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s001ltr.pdf
2011-11-22 00:00:00
29798 1 022511 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf
2011-06-29 00:00:00
29799 1 022511 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s004ltr.pdf
2011-05-25 00:00:00
29800 1 022511 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s007ltr.pdf
2012-10-03 00:00:00
29801 1 022511 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s008ltr.pdf
2012-10-11 00:00:00
29802 1 022511 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s012ltr.pdf
2014-02-27 00:00:00
29803 1 022511 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s015ltr.pdf
2015-03-26 00:00:00
29804 1 022511 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s017ltr.pdf
2014-12-23 00:00:00
29805 1 022512 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf
2010-10-20 00:00:00
29806 1 022512 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s004ltr.pdf
2011-03-08 00:00:00
29807 1 022512 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s009ltr.pdf
2012-01-19 00:00:00
29808 1 022512 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s010ltr.pdf
2012-05-02 00:00:00
29809 1 022512 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s011ltr.pdf
2012-06-05 00:00:00
29810 1 022512 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s016ltr.pdf
2012-12-26 00:00:00
29811 1 022512 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s017ltr.pdf
2013-04-30 00:00:00
29812 1 022512 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s018ltr.pdf
2014-04-09 00:00:00
29813 1 022512 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s031ltr.pdf
2015-08-28 00:00:00
29814 1 022516 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022516s000ltr.pdf
2010-11-09 00:00:00
29815 1 022518 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf
2011-08-22 00:00:00
29816 1 022518 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s005ltr.pdf
2012-08-23 00:00:00
29817 1 022518 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010lt
r.pdf 2012-11-29 00:00:00
29818 1 022518 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010lt
r.pdf 2012-11-29 00:00:00
29819 1 022518 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s013ltr.pdf
2013-08-22 00:00:00
29820 1 022518 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022518Orig1s014ltr.pdf
2014-04-18 00:00:00
29821 1 022518 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641
Orig1s005ltr.pdf 2016-07-13 00:00:00
29822 1 022519 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022519s000ltr.pdf
2011-04-28 00:00:00
29823 1 022522 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022522Orig1s003ltr.pdf
2013-08-27 00:00:00
29824 1 022522 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022522Orig1s006ltr.pdf
2015-11-25 00:00:00
29825 14 022523 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29826 14 022523 SUPPL 2 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29827 1 022524 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022524s000ltr.pdf
2010-07-27 00:00:00
29828 1 022524 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022524Orig1s002ltr.pdf
2013-10-31 00:00:00
29829 1 022525 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022525s000ltr.pdf
2010-06-24 00:00:00
29830 1 022525 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s005ltr.pdf
2014-07-07 00:00:00
29831 1 022526 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022526Orig1s002ltr.pdf
2016-04-11 00:00:00
29832 1 022527 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s006ltr.pdf
2012-03-20 00:00:00
29833 1 022527 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022527Orig1s009ltr.pdf
2014-05-01 00:00:00
29834 1 022527 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022527Orig1s010ltr.pdf
2013-05-29 00:00:00
29835 1 022527 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s019ltr.pdf
2015-08-06 00:00:00
29836 1 022529 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022529Orig1s000ltr.pdf
2012-06-27 00:00:00
29837 1 022529 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022529Orig1s003ltr.pdf
2014-12-11 00:00:00
29838 1 022532 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,
022532s004,022574s004ltr.pdf 2012-04-12 00:00:00
29839 1 022532 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532
Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf 2015-06-03 00:00:00
29840 1 022534 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022534s000ltr.pdf
2011-05-05 00:00:00
29841 1 022534 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022534Orig1s004ltr.pdf
2014-10-31 00:00:00
29842 1 022536 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022536s000ltr.pdf
2010-03-22 00:00:00
29843 1 022541 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022541s000ltr.pdf
2010-08-11 00:00:00
29844 1 022544 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s003ltr.pdf
2011-05-03 00:00:00
29845 1 022544 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544s006ltr.pdf
2012-02-03 00:00:00
29846 1 022545 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s001ltr.pdf
2011-04-01 00:00:00
29847 1 022545 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s005ltr.pdf
2011-10-14 00:00:00
29848 1 022545 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s007ltr.pdf
2012-02-07 00:00:00
29849 1 022545 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s008ltr.pdf
2011-11-16 00:00:00
29850 1 022545 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s010ltr.pdf
2012-02-06 00:00:00
29851 1 022545 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s016ltr.pdf
2015-04-01 00:00:00
29852 1 022547 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022547s000TAltr.pdf
2011-03-08 00:00:00
29854 1 022555 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022555s000ltr.pdf
2010-06-08 00:00:00
29855 1 022560 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf
2011-02-15 00:00:00
29856 1 022560 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s003ltr.pdf
2011-08-24 00:00:00
29857 1 022560 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022560Orig1s004ltr.pdf
2012-08-15 00:00:00
29858 1 022560 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s006ltr.pdf
2015-03-27 00:00:00
29859 1 022562 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022562s000ltr.pdf
2010-03-22 00:00:00
29860 1 022562 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022562Orig1s002ltr.pdf
2013-08-06 00:00:00
29861 1 022563 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022563Orig1s002ltr.pdf
2012-10-02 00:00:00
29862 1 022565 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022565s000ltr.pdf
2010-06-03 00:00:00
29863 1 022565 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022565Orig1s002ltr.pdf
2015-04-02 00:00:00
29864 1 022567 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022567Orig1s005ltr.pdf
2012-12-26 00:00:00
29865 1 022567 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s011ltr.pdf
2014-04-09 00:00:00
29866 1 022568 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,
021720s006ltr.pdf 2010-11-30 00:00:00
29867 1 022568 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720
Orig1s009,022568Orig1s006ltr.pdf 2012-09-06 00:00:00
29868 1 022569 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569
Orig1s019,022569Orig1s020ltr.pdf 2014-12-31 00:00:00
29869 1 022569 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569
Orig1s019,022569Orig1s020ltr.pdf 2014-12-31 00:00:00
29870 1 022569 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022569Orig1s022ltr.pdf
2015-12-22 00:00:00
29871 1 022571 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022571s000ltr.pdf
2010-08-02 00:00:00
29872 1 022572 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022572s000ltr.pdf
2012-02-14 00:00:00
29873 1 022572 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022572Orig1s004ltr.pdf
2016-01-21 00:00:00
29874 1 022573 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022573s000ltr.pdf
2010-12-28 00:00:00
29875 1 022574 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,
022532s004,022574s004ltr.pdf 2012-04-12 00:00:00
29876 14 022575 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29877 14 022575 SUPPL 7 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29878 14 022575 SUPPL 12 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29879 14 022575 SUPPL 17 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
29880 1 022577 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s042,022577
Orig1s002ltr.pdf 2012-08-20 00:00:00
29881 1 022577 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s046,022577
Orig1s003ltr.pdf 2013-07-26 00:00:00
29882 1 022577 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s048,022577
Orig1s006ltr.pdf 2013-10-25 00:00:00
29883 1 022578 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022578s000ltr.pdf
2010-09-08 00:00:00
29884 1 022580 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Origs000ltr.pdf
2012-07-18 00:00:00
29885 1 022580 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022580Orig1s004ltr.pdf
2013-04-18 00:00:00
29886 1 022580 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s
012ltr.pdf 2014-09-30 00:00:00
29887 1 022580 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s
012ltr.pdf 2014-09-30 00:00:00
29888 1 022581 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022581Orig1s006ltr.pdf
2015-05-04 00:00:00
29889 1 040009 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-009_Isosorbide
%20Dinitrate_Approv.pdf 2004-06-07 00:00:00
29890 1 040026 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40026ltr.pdf
1998-09-25 00:00:00
29891 1 040098 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40098_Acetaminophen
%20And%20Codeine%20Phosphate_Approv.pdf 2003-12-23 00:00:00
29892 1 040124 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040124s014ltr.pdf
2008-01-09 00:00:00
29893 1 040136 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040136s005ltr.pdf
2014-02-28 00:00:00
29894 1 040140 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40140ltr.pdf
1998-11-20 00:00:00
29895 1 040162 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf 1998-
01-20 00:00:00
29896 1 040213 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40213ltr.pdf
1998-05-29 00:00:00
29897 1 040226 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40226_Perphenazaine_Approv.pd
f 2004-06-14 00:00:00
29898 1 040230 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40230ltr.pdf
1999-02-26 00:00:00
29899 1 040241 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40241ltr.pdf
2004-06-09 00:00:00
29900 1 040251 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40251ltr.pdf
1999-09-27 00:00:00
29901 1 040254 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40254ltr.pdf
1998-12-24 00:00:00
29902 1 040256 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40256ltr.pdf
2003-04-08 00:00:00
29903 1 040257 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40257ltr.pdf
1998-08-04 00:00:00
29904 1 040260 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40260ltr.pdf
1998-07-17 00:00:00
29905 1 040263 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40263ltr.pdf
1999-02-26 00:00:00
29906 1 040273 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40273ltr.pdf
1998-09-09 00:00:00
29907 1 040275 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40275ltr.pdf
1998-12-29 00:00:00
29908 1 040276 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40276ltr.pdf
1998-11-25 00:00:00
29909 1 040278 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40278_Fluorouracil_Approv.pdf
2004-06-04 00:00:00
29910 1 040279 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Approv.pdf
2004-06-04 00:00:00
29911 1 040281 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40281ltr.pdf
1998-09-30 00:00:00
29912 1 040282 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40282ltr.pdf
1999-12-23 00:00:00
29913 1 040285 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40285ltr.pdf
1999-07-19 00:00:00
29914 1 040286 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40286ltr.pdf
1999-02-26 00:00:00
29915 1 040288 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40288ltr.pdf
1998-11-27 00:00:00
29916 1 040295 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40295ltr.pdf
2000-12-01 00:00:00
29917 1 040297 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40297ltr.pdf
2003-04-08 00:00:00
29918 1 040298 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf
2003-04-08 00:00:00
29919 1 040298 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf
2003-04-08 00:00:00
29920 1 040303 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40303ltr.pdf
1999-12-30 00:00:00
29921 1 040306 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40306LTR.PDF
1999-10-20 00:00:00
29922 1 040308 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40308ltr.pdf
2000-07-26 00:00:00
29923 1 040311 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40311ltr.pdf
1999-12-01 00:00:00
29924 1 040319 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40319ltr.pdf
1999-09-07 00:00:00
29925 1 040321 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40321ltr.pdf
2003-04-08 00:00:00
29926 1 040322 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40322ltr.pdf
2000-01-19 00:00:00
29927 1 040323 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40323ltr.pdf
1999-05-13 00:00:00
29928 1 040326 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40326ltr.pdf
1999-04-21 00:00:00
29929 1 040327 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40327ltr.pdf
2000-02-15 00:00:00
29930 1 040333 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40333ltr.pdf
2000-01-27 00:00:00
29931 1 040334 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Approv.p
df 2004-06-04 00:00:00
29932 1 040335 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40335ltr.pdf
2000-04-20 00:00:00
29933 1 040338 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40338ltr.pdf
2001-01-31 00:00:00
29934 1 040342 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40342ltr.pdf
2001-01-31 00:00:00
29935 1 040347 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40347ltr.pdf
2000-04-25 00:00:00
29936 1 040355 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40355ltr.pdf
2000-05-31 00:00:00
29937 1 040356 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40356ltr.pdf
2000-05-31 00:00:00
29938 1 040358 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40358ltr.pdf
2000-05-31 00:00:00
29939 1 040361 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-
361_Dextroamphetamine%20Sulfate_Approv.pdf 2004-06-02 00:00:00
29940 1 040362 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40362ltr.pdf
2001-08-29 00:00:00
29941 1 040371 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40371ltr.pdf
2000-12-29 00:00:00
29942 1 040372 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40372ltr.pdf
2000-06-08 00:00:00
29943 1 040374 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40374ltr.pdf
2001-06-05 00:00:00
29944 1 040377 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40377ltr.pdf
2002-01-04 00:00:00
29945 1 040379 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40379ltr.pdf
2000-11-15 00:00:00
29946 1 040386 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40386ltr.pdf
2001-06-05 00:00:00
29947 1 040395 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40395ltr.pdf
2000-11-27 00:00:00
29948 1 040396 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40396ltr.pdf
2001-02-27 00:00:00
29949 1 040404 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40404ltr.pdf
2001-03-29 00:00:00
29950 1 040410 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40410Ltr.pdf
2001-02-09 00:00:00
29951 1 040411 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40411ltr.pdf
2001-03-27 00:00:00
29952 1 040419 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40419ltr.pdf
2001-05-31 00:00:00
29953 1 040421 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40421ltr.pdf
2001-06-21 00:00:00
29954 1 040422 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040422Orig1s033,s034lt
r.pdf 2014-02-14 00:00:00
29955 1 040422 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040422Orig1s036ltr.pdf
2015-01-06 00:00:00
29956 1 040423 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40423ltr.pdf
2003-04-10 00:00:00
29957 1 040432 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,
040658s006,040846s005,089699s044ltr.pdf 2015-10-22 00:00:00
29959 1 040446 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40446ltr.pdf
2003-04-09 00:00:00
29960 1 040486 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/040486Orig1s000ltr.pdf
2015-03-04 00:00:00
29962 1 040640 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040640s000LTR.pdf
2006-07-13 00:00:00
29963 1 040712 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040712s000LTR.pdf
2006-08-11 00:00:00
29965 1 040770 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/040735s004,040770s003l
tr.pdf 2011-08-29 00:00:00
29966 1 040846 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,
040658s006,040846s005,089699s044ltr.pdf 2015-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/040861s000ltr.pdf
2010-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050006s079ltr.pdf
2008-02-13 00:00:00
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Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 2016-04-05
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf
2002-06-18 00:00:00
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Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf 2014-09-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007
Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 2016-04-05
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50065slr040,scm039ltr.
pdf 2003-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50065s043,044ltr.pdf
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2004-06-01 00:00:00
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2013-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s219ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50138s228ltr.pdf
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tr.pdf 2009-12-31 00:00:00
29986 1 050138 SUPPL 234 0

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s231ltr.pdf 2012-09-07 00:00:00
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Orig1s232ltr.pdf 2014-04-29 00:00:00
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2015-10-14 00:00:00
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Orig1s232ltr.pdf 2014-04-29 00:00:00
29990 1 050141 SUPPL 233 0

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2015-10-14 00:00:00
29991 1 050162 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50
639s013ltr.pdf 2004-10-04 00:00:00
29992 1 050162 SUPPL 92 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050162Orig1s092,s093lt
r.pdf 2014-06-27 00:00:00
29993 1 050162 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s095,s096lt
r.pdf 2016-03-25 00:00:00
29994 1 050182 SUPPL 122 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50182s122ltr.pdf
2002-05-23 00:00:00
29995 1 050207 SUPPL 65 0

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2008-01-09 00:00:00
29996 1 050207 SUPPL 67 0

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tr.pdf 2010-11-08 00:00:00
29997 1 050218 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50218slr051ltr.pdf
2004-06-02 00:00:00
29998 1 050261 SUPPL 100 0

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2008-04-25 00:00:00
29999 1 050297 SUPPL 21 0
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050297s021LTR.pdf 2006-08-14 00:00:00
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2008-01-09 00:00:00
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2008-05-28 00:00:00
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050297s030ltr.pdf 2008-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050297Orig1s031ltr.pdf
2012-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050317s172ltr.pdf
2008-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50347s052ltr.pdf
2004-08-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050347Orig1s060ltr.pdf
2012-08-17 00:00:00
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2002-03-01 00:00:00
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2009-06-08 00:00:00
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2004-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr095ltr.pdf
2004-07-01 00:00:00
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2008-05-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s101ltr.pdf
2008-09-17 00:00:00
30013 1 050417 SUPPL 11 0

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2004-05-04 00:00:00
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.pdf 2004-08-25 00:00:00
30015 1 050420 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012l
tr.pdf 2010-11-22 00:00:00
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639s013ltr.pdf 2004-10-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50441s47ltr.pdf
2001-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr04
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30019 1 050441 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050441s059ltr.pdf
2010-10-20 00:00:00
30020 1 050441 SUPPL 61 0

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050639s022ltr.pdf 2011-06-10 00:00:00
30021 1 050441 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s
068ltr.pdf 2014-06-12 00:00:00
30022 1 050441 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s
068ltr.pdf 2014-06-12 00:00:00
30023 1 050442 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050442Orig1s017ltr.pdf
2014-09-25 00:00:00
30024 1 050443 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50443slr035ltr.pdf
2003-03-26 00:00:00
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2002-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf
2002-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50444slr042,043ltr.pdf
2004-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050444Orig1s048ltr.pdf
2014-10-27 00:00:00
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2002-02-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf
2002-02-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50
649s015ltr.pdf 2005-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf
2004-06-01 00:00:00
30033 1 050445 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,
050649s018ltr.pdf 2005-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050444s045,
050445s027ltr.pdf 2007-01-18 00:00:00
30035 1 050445 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050445Orig1s029ltr.pdf
2015-02-27 00:00:00
30036 1 050461 SUPPL 135 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr135ltr.pdf
2004-01-22 00:00:00
30037 1 050461 SUPPL 139 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr139ltr.pdf
2004-06-07 00:00:00
30038 1 050467 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629s
lr010,013ltr.pdf 2002-09-25 00:00:00
30039 1 050467 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629s
lr010,013ltr.pdf 2002-09-25 00:00:00
30040 1 050467 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-
014slr016,50467se1-068,slr069ltr.pdf 2003-05-30 00:00:00
30041 1 050467 SUPPL 71 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050467s071,050629s019l
tr.pdf 2011-09-29 00:00:00
30042 1 050475 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50475slr046ltr.pdf
2003-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050475s054ltr.pdf
2010-10-25 00:00:00
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4ltr.pdf 2003-04-18 00:00:00
30045 1 050480 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr01
6,50480slr037,50533slr033ltr.pdf 2004-03-16 00:00:00
30046 1 050480 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007
Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 2016-04-05
00:00:00
30047 1 050517 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr046ltr.pdf
2004-06-07 00:00:00
30048 1 050517 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050517s047ltr.pdf
2007-09-25 00:00:00
30049 1 050527 SUPPL 20 0
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2004-06-02 00:00:00
30050 1 050527 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046,
050527s022, 050528s020ltr.pdf 2007-06-07 00:00:00
30051 1 050528 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046,
050527s022, 050528s020ltr.pdf 2007-06-07 00:00:00
30052 1 050533 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050533s036ltr.pdf
2008-02-13 00:00:00
30053 1 050533 SUPPL 40 0

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Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf 2013-04-30 00:00:00
30054 1 050533 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007
Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf 2014-09-16 00:00:00
30055 1 050533 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007
Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 2016-04-05
00:00:00
30056 1 050536 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50536slr016ltr.pdf
2004-02-27 00:00:00
30057 1 050536 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50536slr018ltr.pdf
2003-12-22 00:00:00
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2006-01-20 00:00:00
30059 1 050536 SUPPL 22 0

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2012-02-21 00:00:00
30060 1 050537 SUPPL 13 0

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2,50615slr003ltr.pdf 2002-07-14 00:00:00
30061 1 050537 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,
050615s014ltr.pdf 2016-01-20 00:00:00
30062 1 050541 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050541Orig1s024ltr.pdf
2012-12-19 00:00:00
30063 1 050542 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50542s16ltr.pdf
2004-05-27 00:00:00
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4,50760slr003,50761slr003ltr.pdf 2003-06-08 00:00:00
30065 1 050542 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50
760s008,50761s008rltr.pdf 2004-07-21 00:00:00
30066 1 050542 SUPPL 26 0

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50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
30067 1 050542 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
30068 1 050542 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754O
rig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 2015-09-28 00:00:00
30069 1 050542 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754
Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 2015-12-08 00:00:00
30070 1 050545 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr03
3,50545slr037ltr.pdf 2003-06-08 00:00:00
30071 1 050545 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr03
3,50545slr037ltr.pdf 2003-06-08 00:00:00
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2004-04-07 00:00:00
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2005-07-29 00:00:00
30074 1 050547 SUPPL 47 0
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2002-01-18 00:00:00
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tr.pdf 2009-06-02 00:00:00
30076 1 050547 SUPPL 70 0
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Orig1s040ltr.pdf 2014-02-25 00:00:00
30077 1 050555 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018
ltr.pdf 2003-03-26 00:00:00
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2004-07-21 00:00:00
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5ltr.pdf 2004-05-26 00:00:00
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050643s021ltr.pdf 2007-07-31 00:00:00
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2004-05-27 00:00:00
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8ltr.pdf 2004-06-01 00:00:00
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050720s023ltr.pdf 2008-12-11 00:00:00
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2008-04-02 00:00:00
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tr.pdf 2011-10-03 00:00:00
30087 1 050564 SUPPL 55 0

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lr035,037,50625slr039,040ltr.pdf 2004-02-27 00:00:00
30089 1 050573 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574
Orig1s047,050625Orig1s053ltr.pdf 2013-05-07 00:00:00
30090 1 050573 SUPPL 41 0

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050630s026LTR.pdf 2006-08-07 00:00:00
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.pdf 2004-12-02 00:00:00
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tr.pdf 2007-03-23 00:00:00
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050590s059ltr.pdf 2010-12-28 00:00:00
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s024ltr.pdf 2011-06-13 00:00:00
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Orig1s025ltr.pdf 2012-10-09 00:00:00
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1999-04-22 00:00:00
30139 1 050591 SUPPL 30 0

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Orig1s040ltr.pdf 2014-02-25 00:00:00
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Orig1s042ltr.pdf 2015-03-24 00:00:00
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2004-05-27 00:00:00
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5ltr.pdf 2004-06-07 00:00:00
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r.pdf 2014-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046lt
r.pdf 2014-09-23 00:00:00
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Orig1s033ltr.pdf 2015-07-07 00:00:00
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Orig1s034ltr.pdf 2015-08-28 00:00:00
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r.pdf 2014-11-19 00:00:00
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.pdf 2004-09-17 00:00:00
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0ltr.pdf 2003-08-28 00:00:00
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014slr016,50467se1-068,slr069ltr.pdf 2003-05-30 00:00:00
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tr.pdf 2009-11-25 00:00:00
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bl.pdf 2007-03-15 00:00:00
30200 1 050634 SUPPL 20 0
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050634s020ltr.pdf 2007-07-16 00:00:00
30201 1 050634 SUPPL 23 0

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30202 1 050638 SUPPL 7 0

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30203 1 050638 SUPPL 10 0

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30208 1 050639 SUPPL 15 0

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2008-02-25 00:00:00
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029ltr.pdf 2014-06-27 00:00:00
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2004-03-24 00:00:00
30212 1 050640 SUPPL 17 0

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2015-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s8ltr.pdf
2002-03-21 00:00:00
30214 1 050641 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s010ltr.pdf
2002-06-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s014ltr.pdf
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30216 1 050641 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050641s018ltr.pdf
2012-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067,
050643s021ltr.pdf 2007-07-31 00:00:00
30218 1 050643 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643
Orig1s022ltr.pdf 2014-09-29 00:00:00
30219 1 050646 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf
2002-03-29 00:00:00
30220 1 050649 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50
649s015ltr.pdf 2005-02-17 00:00:00
30221 1 050649 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50649slr016,017ltr.pdf
2004-06-01 00:00:00
30222 1 050649 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050649s021ltr.pdf
2007-06-04 00:00:00
30223 1 050649 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050649s023ltr.pdf
2010-09-17 00:00:00
30224 1 050649 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050649Orig1s025ltr.pdf
2015-03-11 00:00:00
30225 1 050655 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50655slr013ltr.pdf
2003-08-15 00:00:00
30226 1 050655 SUPPL 16 0

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2006-08-14 00:00:00
30227 1 050655 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050655s017ltr.pdf
2008-04-16 00:00:00
30228 1 050655 SUPPL 23 0

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2015-04-06 00:00:00
30229 1 050658 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050590s054,050658s020l
tr.pdf 2007-03-23 00:00:00
30230 1 050658 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050658s022ltr.pdf
2008-04-22 00:00:00
30231 1 050658 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050590Orig1s062,050658
Orig1s025ltr.pdf 2012-10-09 00:00:00
30232 1 050658 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658
Orig1s029ltr.pdf 2013-10-01 00:00:00
30233 1 050661 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050661Orig1s014ltr.pdf
2014-12-05 00:00:00
30234 1 050662 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50662S29ltr.pdf
2000-10-20 00:00:00
30235 1 050662 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50662s030ltr.pdf
2002-06-06 00:00:00
30236 1 050662 SUPPL 36 0

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698s019,50775s007ltr.pdf 2004-07-21 00:00:00
30237 1 050662 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,
050775s008ltr.pdf 2005-10-20 00:00:00
30238 1 050662 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039,
050698s021, 050775s009LTR.pdf 2006-07-13 00:00:00
30239 1 050662 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040,
050698s022, 050775s011ltr.pdf 2008-01-09 00:00:00
30240 1 050662 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,
050775s012ltr.pdf 2008-05-29 00:00:00
30241 1 050662 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,
050775s013ltr.pdf 2009-11-20 00:00:00
30242 1 050662 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698
s025,s027,050775s014,s016ltr.pdf 2011-05-31 00:00:00
30243 1 050662 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,
050775s018ltr.pdf 2012-07-10 00:00:00
30244 1 050662 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,0
50698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 2013-09-11 00:00:00
30245 1 050662 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698
Orig1s037,050775Orig1s025ltr.pdf 2015-10-28 00:00:00
30246 1 050664 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024,
050665s024ltr.pdf 2007-09-25 00:00:00
30247 1 050665 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr02
3ltr.pdf 2004-06-25 00:00:00
30248 1 050670 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024,
050693s010, 050730s014ltr.pdf 2007-11-08 00:00:00
30249 1 050671 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050671s010ltr.pdf
2007-09-25 00:00:00
30250 1 050671 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050671s014ltr.pdf
2009-03-13 00:00:00
30251 1 050672 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf
1999-08-24 00:00:00
30252 1 050672 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf
2002-04-11 00:00:00
30253 1 050672 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr02
5ltr.pdf 2004-06-07 00:00:00
30254 1 050672 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032lt
r.pdf 2014-09-23 00:00:00
30255 1 050672 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032lt
r.pdf 2014-09-23 00:00:00
30256 1 050672 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672
Orig1s033ltr.pdf 2015-07-07 00:00:00
30257 1 050672 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672
Orig1s034ltr.pdf 2015-08-28 00:00:00
30258 1 050674 SUPPL 14 0
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050675s017ltr.pdf 2007-06-07 00:00:00
30259 1 050674 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050674Orig1s015,050675
Orig1s018ltr.pdf 2013-06-24 00:00:00
30260 1 050675 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf
1998-11-20 00:00:00
30261 1 050679 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr
.pdf 2002-08-21 00:00:00
30262 1 050679 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050679s024ltr_CKD.pdf
2007-11-26 00:00:00
30263 1 050679 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050679Orig1s031ltr.pdf
2014-05-06 00:00:00
30264 1 050679 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050679Orig1s034ltr.pdf
2013-03-18 00:00:00
30265 1 050680 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767
Orig1s011ltr.pdf 2014-05-12 00:00:00
30266 1 050682 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50682slr019ltr.pdf
2002-10-28 00:00:00
30267 1 050682 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf
2012-02-07 00:00:00
30268 1 050684 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50684slr038ltr.pdf
2004-02-03 00:00:00
30269 1 050684 SUPPL 45 0

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30270 1 050684 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050684s051,
s052ltr.pdf 2008-04-22 00:00:00
30271 1 050684 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050684s061,050750s016l
tr.pdf 2012-05-15 00:00:00
30272 1 050684 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s
080,050750Orig1s021,s026,s030ltr.pdf 2013-09-11 00:00:00
30273 1 050684 SUPPL 74 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s
080,050750Orig1s021,s026,s030ltr.pdf 2013-09-11 00:00:00
30274 1 050684 SUPPL 84 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,0
50750Orig1s034,s035ltr.pdf 2016-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014l
tr.pdf 2009-02-12 00:00:00
30276 1 050685 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015l
tr.pdf 2010-11-08 00:00:00
30277 1 050686 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050686s016ltr.pdf
2011-03-16 00:00:00
30278 1 050687 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF
2000-02-10 00:00:00
30279 1 050687 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF
2000-02-10 00:00:00
30280 1 050688 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF
2000-02-10 00:00:00
30281 1 050688 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF
2000-02-10 00:00:00
30282 1 050688 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF
2000-02-10 00:00:00
30283 1 050688 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF
2000-02-10 00:00:00
30284 1 050689 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50689s13ltr.pdf
2001-11-09 00:00:00
30285 1 050689 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050689s016ltr.pdf
2008-05-14 00:00:00
30286 1 050689 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050689Orig1s018ltr.pdf
2014-11-14 00:00:00
30287 1 050693 SUPPL 8 0

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8,50730slr011ltr.pdf 2004-03-28 00:00:00
30288 1 050693 SUPPL 10 0
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050693s010, 050730s014ltr.pdf 2007-11-08 00:00:00
30289 1 050693 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021l
tr.pdf 2009-03-10 00:00:00
30290 1 050693 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,
050711s031,050730s026,050733s030,050784s018ltr.pdf 2011-02-03 00:00:00
30291 1 050693 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730
Orig1s029ltr.pdf 2014-06-11 00:00:00
30292 1 050693 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730
Orig1s031ltr.pdf 2013-02-21 00:00:00
30293 1 050693 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730
Orig1s034ltr.pdf 2016-05-25 00:00:00
30294 1 050698 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040,
050698s022, 050775s011ltr.pdf 2008-01-09 00:00:00
30295 1 050698 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698
s025,s027,050775s014,s016ltr.pdf 2011-05-31 00:00:00
30296 1 050698 SUPPL 26 0

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s026,s030,050775s015,s019ltr.pdf 2012-05-09 00:00:00
30297 1 050698 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,
050775s017lltr.pdf 2012-06-05 00:00:00
30298 1 050698 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,0
50698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 2013-09-11 00:00:00
30299 1 050698 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698
Orig1s033,050775Orig1s022ltr.pdf 2016-05-31 00:00:00
30300 1 050698 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698
Orig1s035,050775Orig1s023ltr.pdf 2014-07-28 00:00:00
30301 1 050698 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698
Orig1s037,050775Orig1s025ltr.pdf 2015-10-28 00:00:00
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2002-02-21 00:00:00
30303 1 050705 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050705s006ltr.pdf
2008-12-29 00:00:00
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2005-05-26 00:00:00
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2010-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s031ltr.pdf
2013-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s032,s034lt
r.pdf 2013-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050706Orig1s035ltr.pdf
2014-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s034,050709s026l
tr.pdf 2009-02-18 00:00:00
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028s030ltr.pdf 2011-07-19 00:00:00
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tr.pdf 2012-07-09 00:00:00
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Orig1s036ltr.pdf 2013-09-09 00:00:00
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Orig1s038ltr.pdf 2015-05-21 00:00:00
30314 1 050709 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50708slr021,50709slr01
3ltr.pdf 2004-06-23 00:00:00
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050709s019ltr.pdf 2006-04-05 00:00:00
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050709s020LTR.pdf 2006-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s
028s030ltr.pdf 2011-07-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50710s8ltr.pdf
2001-12-14 00:00:00
30319 1 050710 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710s011ltr.pdf
2002-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50710slr016ltr.pdf
2003-07-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr019ltr.pdf
2004-04-29 00:00:00
30322 1 050710 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711s
lr015,017ltr.pdf 2004-01-22 00:00:00
30323 1 050710 SUPPL 23 0
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050711s019, 050784s007ltr.pdf 2007-11-08 00:00:00
30324 1 050710 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,
050784s012ltr.pdf 2009-03-03 00:00:00
30325 1 050710 SUPPL 32 0

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050784s017ltr.pdf 2010-08-17 00:00:00
30326 1 050710 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710
Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 2012-11-06
00:00:00
30327 1 050710 SUPPL 37 0

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Orig1s034,050784Orig11s021ltr.pdf 2014-06-11 00:00:00
30328 1 050710 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,
050711s035,050730s030,050733s034,050784s022ltr.pdf 2012-06-08 00:00:00
30329 1 050710 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,
050784s023ltr.pdf 2013-02-21 00:00:00
30330 1 050711 SUPPL 8 0

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8ltr.pdf 2002-10-16 00:00:00
30331 1 050711 SUPPL 9 0
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2002-05-24 00:00:00
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lr015,017ltr.pdf 2004-01-22 00:00:00
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050784s017ltr.pdf 2010-08-17 00:00:00
30335 1 050711 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710
Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 2012-11-06
00:00:00
30336 1 050711 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711
Orig1s034,050784Orig11s021ltr.pdf 2014-06-11 00:00:00
30337 1 050711 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,
050711s035,050730s030,050733s034,050784s022ltr.pdf 2012-06-08 00:00:00
30338 1 050711 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,
050784s023ltr.pdf 2013-02-21 00:00:00
30339 1 050715 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf
2002-06-12 00:00:00
30340 1 050715 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715s
lr019,020ltr.pdf 2004-06-09 00:00:00
30341 1 050715 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050715s022,050716s024l
tr.pdf 2005-07-26 00:00:00
30342 1 050715 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050715s024,050716s025l
tr.pdf 2006-03-23 00:00:00
30343 1 050715 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050715Orig1s033,050716
Orig1s034ltr.pdf 2013-05-07 00:00:00
30344 1 050716 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf
2002-06-12 00:00:00
30345 1 050716 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715s
lr019,020ltr.pdf 2004-02-27 00:00:00
30346 1 050716 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050715s024,050716s025l
tr.pdf 2006-03-23 00:00:00
30347 1 050716 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050715Orig1s033,050716
Orig1s034ltr.pdf 2013-05-07 00:00:00
30348 1 050717 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50717slr004ltr.pdf
2002-12-18 00:00:00
30349 1 050717 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050717s005ltr.pdf
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30350 1 050718 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50718s06ltr.pdf
1999-06-28 00:00:00
30351 1 050718 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50718s019ltr.pdf
2004-10-29 00:00:00
30352 1 050718 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50718s019,020ltr.pdf
2005-02-03 00:00:00
30353 1 050718 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf
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30354 1 050718 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050718s033ltr.pdf
2008-06-13 00:00:00
30355 1 050718 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050718Orig1s043ltr.pdf
2012-09-24 00:00:00
30356 1 050718 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050718Orig1s045ltr.pdf
2013-09-04 00:00:00
30357 1 050719 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50719slr007ltr.pdf
2003-05-29 00:00:00
30358 1 050719 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50719s008ltr.pdf
2004-09-15 00:00:00
30359 1 050719 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050719s013ltr.pdf
2008-07-01 00:00:00
30360 1 050719 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050719s015ltr.pdf
2010-01-21 00:00:00
30361 1 050719 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050719Orig1s021ltr.pdf
2015-09-10 00:00:00
30362 1 050720 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564slr046,50720slr01
8ltr.pdf 2004-06-01 00:00:00
30363 1 050720 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050564s048,050721s021l
tr.pdf 2005-08-11 00:00:00
30364 1 050720 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s050,
050720s023ltr.pdf 2008-12-11 00:00:00
30365 1 050722 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF
2000-07-28 00:00:00
30366 1 050722 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr00
5,50723slr006,50722slr008ltr.pdf 2003-03-10 00:00:00
30367 1 050722 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,507
58s14,50759s19ltr.pdf 2007-09-25 00:00:00
30368 1 050722 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,
050758s018,050759s023ltr.pdf 2009-03-05 00:00:00
30369 1 050722 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,
050758s019,050759s024ltr.pdf 2009-06-23 00:00:00
30370 1 050722 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,
050758s022,050759s028ltr.pdf 2009-11-09 00:00:00
30371 1 050722 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,
050758s024,050759s031ltr.pdf 2012-06-12 00:00:00
30372 1 050722 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,0
50723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 2013-10-01
00:00:00
30373 1 050722 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723
Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 2015-11-19 00:00:00
30374 1 050723 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf
2000-12-22 00:00:00
30375 1 050723 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,
050758s013,050759s018ltr.pdf 2008-01-09 00:00:00
30376 1 050723 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_
050758s016_050759s021ltr.pdf 2008-05-15 00:00:00
30377 1 050723 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019,
050723s017, 050758s017, 050759s022ltr.pdf 2008-12-24 00:00:00
30378 1 050723 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723
Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf 2012-09-27 00:00:00
30379 1 050723 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050723s021ltr.pdf
2009-11-20 00:00:00
30380 1 050723 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,
050758s022,050759s028ltr.pdf 2009-11-09 00:00:00
30381 1 050723 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,
050758s024,050759s031ltr.pdf 2012-06-12 00:00:00
30382 1 050723 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,0
50723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 2013-10-01
00:00:00
30383 1 050723 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723
Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 2015-11-19 00:00:00
30384 1 050725 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf
2004-05-27 00:00:00
30385 1 050725 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr03
9,50725slr017,50726slr014ltr.pdf 2003-06-08 00:00:00
30386 1 050725 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037,
050597s044, 050725025, 050726s019ltr.pdf 2008-12-11 00:00:00
30387 1 050725 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045,
050575s038, 050726s020, 050725s026ltr.pdf 2008-04-02 00:00:00
30388 1 050725 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,05
0575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022l
tr.pdf 2013-01-24 00:00:00
30390 1 050726 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf
2004-05-27 00:00:00
30391 1 050726 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr03
9,50725slr017,50726slr014ltr.pdf 2003-06-08 00:00:00
30392 1 050726 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045,
050575s038, 050726s020, 050725s026ltr.pdf 2008-04-02 00:00:00
30393 1 050726 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,05
0575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022l
tr.pdf 2013-01-24 00:00:00
30394 1 050730 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-
670S015_Zithromax_Approv.pdf 2000-11-13 00:00:00
30395 1 050730 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr00
5,50730slr007ltr.pdf 2002-10-16 00:00:00
30396 1 050730 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr00
8,50730slr011ltr.pdf 2004-03-28 00:00:00
30397 1 050730 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr00
9,50730slr012ltr.pdf 2004-01-22 00:00:00
30398 1 050730 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,
050711s031,050730s026,050733s030,050784s018ltr.pdf 2011-02-03 00:00:00
30399 1 050730 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710
Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 2012-11-06
00:00:00
30400 1 050730 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730
Orig1s034ltr.pdf 2016-05-25 00:00:00
30401 1 050733 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733slr006ltr.pdf
2002-10-16 00:00:00
30402 1 050733 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50733slr007ltr.pdf
2003-06-22 00:00:00
30403 1 050733 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr012ltr.pdf
2004-01-22 00:00:00
30404 1 050733 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050733s018ltr.pdf
2007-11-08 00:00:00
30405 1 050733 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050733s023ltr.pdf
2009-03-03 00:00:00
30406 1 050733 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050733s029ltr.pdf
2010-08-17 00:00:00
30407 1 050733 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050733Orig1s031ltr.pdf
2014-06-10 00:00:00
30408 1 050733 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050733s033ltr.pdf
2011-11-21 00:00:00
30409 1 050733 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,
050711s035,050730s030,050733s034,050784s022ltr.pdf 2012-06-08 00:00:00
30410 1 050733 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050733Orig1s040ltr.pdf
2016-05-26 00:00:00
30411 1 050739 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50739S2LTR.PDF
1999-11-24 00:00:00
30412 1 050739 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr
.pdf 2004-09-03 00:00:00
30413 1 050739 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013l
tr.pdf 2005-07-21 00:00:00
30414 1 050739 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013,
050749s017ltr.pdf 2007-07-05 00:00:00
30415 1 050739 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749
Orig1s023ltr.pdf 2015-11-20 00:00:00
30416 1 050740 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50740slr014ltr.pdf
2003-09-25 00:00:00
30417 1 050740 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050740s016ltr.pdf
2008-10-14 00:00:00
30418 1 050741 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741scs004ltr.pdf
2003-11-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050741s011ltr.pdf
2008-07-24 00:00:00
30420 1 050741 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050741Orig1s021ltr.pdf
2013-12-31 00:00:00
30421 1 050741 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050741Orig1s024ltr.pdf
2015-04-17 00:00:00
30422 1 050742 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50742slr011ltr.pdf
2003-01-15 00:00:00
30423 1 050742 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf
2004-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050742s017ltr.pdf
2006-01-30 00:00:00
30425 1 050742 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019,
050742s021ltr.pdf 2007-10-04 00:00:00
30426 1 050742 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s022ltr.pdf
2008-09-16 00:00:00
30427 1 050742 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s026ltr.pdf
2009-12-24 00:00:00
30428 1 050746 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s020ltr.pdf
2015-12-15 00:00:00
30429 1 050747 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050747s008,050748s008l
tr.pdf 2008-06-20 00:00:00
30430 1 050747 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,
050748s010ltr.pdf 2010-11-22 00:00:00
30431 1 050747 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050747s014,050748s013l
tr.pdf 2012-01-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50747ltr.pdf
1999-09-21 00:00:00
30433 1 050748 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,
050748s010ltr.pdf 2010-11-22 00:00:00
30434 1 050748 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050747s014,050748s013l
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30435 1 050749 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50749s02ltr.pdf
1999-07-14 00:00:00
30436 1 050749 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr
.pdf 2004-09-03 00:00:00
30437 1 050749 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s014,
050749s018ltr.pdf 2007-09-25 00:00:00
30438 1 050749 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015,
050749s021ltr.pdf 2008-12-19 00:00:00
30439 1 050750 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750slr007ltr.pdf
2003-05-30 00:00:00
30440 1 050750 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750se2-
008ltr.pdf 2003-05-30 00:00:00
30441 1 050750 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s045,050750s012l
tr.pdf 2005-10-20 00:00:00
30442 1 050750 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050750s014LTR.pdf
2006-08-04 00:00:00
30443 1 050750 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050750s015ltr.pdf
2008-04-22 00:00:00
30444 1 050750 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s
080,050750Orig1s021,s026,s030ltr.pdf 2013-09-11 00:00:00
30445 1 050750 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,0
50750Orig1s034,s035ltr.pdf 2016-06-13 00:00:00
30446 1 050751 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50751slr009ltr.pdf
2003-03-26 00:00:00
30447 1 050751 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050751s015ltr.pdf
2011-02-23 00:00:00
30448 1 050753 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50753s2ltr.pdf
2002-03-21 00:00:00
30449 1 050753 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050753Orig1s011ltr.pdf
2013-10-01 00:00:00
30450 1 050753 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050753Orig1s016ltr.pdf
2014-04-29 00:00:00
30451 1 050754 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50754AP.PDF
1998-07-10 00:00:00
30452 1 050754 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50
760s008,50761s008rltr.pdf 2004-07-21 00:00:00
30453 1 050754 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
30454 1 050754 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050754s019ltr.pdf05054
2Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 2015-09-28
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s026ltr.pdf
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757S003_Prevpac_Approv.pdf 1999-08-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-
757S004_Prevpac_Approv.pdf 1999-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723
Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf 2012-09-27 00:00:00
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050758s024,050759s031ltr.pdf 2012-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,0
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00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723
Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf 2015-07-14 00:00:00
30482 1 050758 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723
Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 2015-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,507
58s14,50759s19ltr.pdf 2007-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019,
050723s017, 050758s017, 050759s022ltr.pdf 2008-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,
050758s022,050759s028ltr.pdf 2009-11-09 00:00:00
30489 1 050759 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,
050758s026,050759s033ltr.pdf 2012-06-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,0
50723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 2013-10-01
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723
Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 2015-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50760ltr.pdf
1999-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50
760s008,50761s008rltr.pdf 2004-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050761s009_050760s009l
tr.pdf 2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
30498 1 050760 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,0
50754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 2011-11-21
00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024,
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30500 1 050761 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011,
050761s011,050754s012, 050542s025ltr.pdf 2008-04-02 00:00:00
30501 1 050761 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754
Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 2015-12-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050763s000ltr.pdf
2007-01-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50767ltr.pdf
1999-08-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050767Orig1s010ltr.pdf
2013-06-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,
050775s008ltr.pdf 2005-10-20 00:00:00
30506 1 050775 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039,
050698s021, 050775s009LTR.pdf 2006-07-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,
050775s012ltr.pdf 2008-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,
050775s018ltr.pdf 2012-07-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698
s026,s030,050775s015,s019ltr.pdf 2012-05-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698
Orig1s033,050775Orig1s022ltr.pdf 2016-05-31 00:00:00
30511 1 050775 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698
Orig1s036,050775Orig1s024ltr.pdf 2015-01-09 00:00:00
30512 1 050775 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698
Orig1s037,050775Orig1s025ltr.pdf 2015-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50777ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050777s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05077s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50778ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf
2003-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018lt
r.pdf 2011-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050779s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s018ltr.pdf
2012-01-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s019ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050779Orig1s023ltr.pdf
2014-09-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050779Orig1s025ltr.pdf
2015-10-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50780slr006ltr.pdf
2004-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050780s008ltr.pdf
2005-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050780Orig1s019ltr.pdf
2015-05-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50782LTR-LBL.PDF
2000-11-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-
004,slr006ltr.pdf 2004-01-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-
004,slr006ltr.pdf 2004-01-22 00:00:00
30532 1 050784 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,
050784s012ltr.pdf 2009-03-03 00:00:00
30533 1 050784 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,
050784s017ltr.pdf 2010-08-17 00:00:00
30534 1 050784 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710
Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 2012-11-06
00:00:00
30535 1 050784 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711
Orig1s034,050784Orig11s021ltr.pdf 2014-06-11 00:00:00
30536 1 050784 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,
050784s023ltr.pdf 2013-02-21 00:00:00
30537 1 050784 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711
Orig1s040,050784Orig1s027ltr.pdf 2016-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50785ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785scs003ltr.pdf
2003-06-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050785s006ltr.pdf
2005-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050785s011,s012ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050786s001ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050786Orig1s007ltr.pdf
2013-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050788Orig1s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50789ltr.pdf
2004-07-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf
2003-09-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50791ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050791s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s002ltr.pdf
2008-05-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s004ltr.pdf
2008-12-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791Orig1s005ltr.pdf
2012-09-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s007ltr.pdf
2009-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s008ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050791s011ltr.pdf
2010-11-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s012ltr_cor
rected.pdf 2013-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791s014ltr.pdf
2012-06-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s018,s019lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s022ltr.pdf
2015-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50792ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050793ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050793s014ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50794ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050794s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050794s016,050794s020l
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050794s023ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050794Orig1s028ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050795s005ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050795Orig1s010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74920ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74924ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75110ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75116ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75117ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75122ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75129ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75182
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75191ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75356ap.pdf
2003-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75358ltr.pdf
2000-03-29 00:00:00
30862 1 075366 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75366ta.pdf
2004-06-18 00:00:00
30863 1 075370 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75370ltr.pdf
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75374ltr.pdf
1999-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75375ltr.pdf
1999-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75382ltr.pdf
1999-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75348ltr.pdf
2000-12-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75385ltr.pdf
2003-04-10 00:00:00
30869 1 075387 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75387ltr.pdf
2000-04-06 00:00:00
30870 1 075390 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75390ltr.pdf
2001-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75391ltr.pdf
1999-02-08 00:00:00
30872 1 075394 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75394ltr.pdf
1999-11-22 00:00:00
30873 1 075400 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75400taltr.pdf
2003-04-10 00:00:00
30874 1 075406 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/75406ltr.pdf 1999-
12-15 00:00:00
30875 1 075409 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75409ltr.pdf
2000-06-20 00:00:00
30876 1 075411 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75411ltr.pdf
2000-09-08 00:00:00
30877 1 075417 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75417ltr.pdf
1999-05-27 00:00:00
30878 1 075417 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.p
df 2010-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75423ltr.pdf
2001-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75429ta.pdf
2004-06-17 00:00:00
30881 1 075429 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75429ltr.pdf
2000-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75430ltr.pdf
1999-05-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75431ltr.pdf
1999-12-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75432ltr.pdf
2000-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75434ltr.pdf
2000-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75446ltr.pdf
2000-09-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75448ltr.pdf
2000-06-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75452ta.pdf
2004-06-04 00:00:00
30889 1 075453 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75453ltr.pdf
2000-10-18 00:00:00
30890 1 075453 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75453TA.pdf
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75457ltr.pdf
2001-04-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75459ltr.pdf
2000-08-22 00:00:00
30893 1 075463 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75463ltr.pdf
1999-07-26 00:00:00
30894 1 075465 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75465ltr.pdf
2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75467ltr&TA.pdf
2001-03-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf
2003-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75468ltr.pdf
2000-10-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75469ltr.pdf
2000-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75471ltr.pdf
2000-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75472ltr.pdf
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75472ta.pdf
2004-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75473ltr.pdf
2000-08-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75476ta.pdf
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75476ltr.pdf
2000-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75478TA.pdf
2004-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75479ltr.pdf
2000-08-22 00:00:00
30907 1 075479 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75479ta.pdf
2004-06-03 00:00:00
30908 1 075481 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75481ltr.pdf
2000-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75483ltr.pdf
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75484ltr.pdf
2000-06-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75486TA.pdf
2004-06-04 00:00:00
30912 1 075488 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75488TA.pdf
2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75493ltr.pdf
1999-09-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75500ltr.pdf
2001-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75501ltr.pdf
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75502ltr.pdf
2001-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75506ltr.pdf
2001-08-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75509ltr.pdf
2000-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75511ltr.pdf
2001-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75517ltr.pdf
2000-03-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75520ltr.pdf
2000-05-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75522ltr.pdf
2000-04-17 00:00:00
30923 1 075523 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75523ltr.pdf
2000-03-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ltr.pdf
2000-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75528ltr.pdf
1999-08-30 00:00:00
30926 1 075536 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75536ta.pdf
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75441ltr.pdf
1999-10-22 00:00:00
30928 1 075546 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75546ltr.pdf
2000-01-20 00:00:00
30929 1 075547 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/075547Orig1s006ltr.pdf
2015-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75548ltr.pdf
2001-02-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75549ltr.pdf
2000-06-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75555ltr.pdf
2000-02-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75556ltr.pdf
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75556ta.pdf
2004-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75561ltr.pdf
2000-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75562.ap.pdf
2003-04-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75564ltr.pdf
2000-10-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75567ltr.pdf
2001-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75568ltr.pdf
1999-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75572ta.pdf
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75574ta.pdf
2004-06-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75574ltr.pdf
2000-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75577TA.pdf
2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75578ltr.pdf
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75581ltr.pdf
2000-04-25 00:00:00
30946 1 075583 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75523LTR.PDF
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75584ltr.pdf
2000-02-07 00:00:00
30948 1 075585 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75585ltr.pdf
2000-12-21 00:00:00
30949 1 075588 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75588.ap.pdf
2003-04-10 00:00:00
30950 1 075592 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75592ltr.pdf
2000-05-25 00:00:00
30951 1 075594 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75594.ta.pdf
2003-04-14 00:00:00
30952 1 075595 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75595ltr.pdf
2000-02-28 00:00:00
30953 1 075602 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75602ltr.pdf
2001-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75604.ap.pdf
2003-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75610.apf.pdf
2003-04-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75614ltr.pdf
2001-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75615ltr.pdf
2001-01-26 00:00:00
30958 1 075616 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75616ta.pdf
2004-06-10 00:00:00
30959 1 075618 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75618ltr.pdf
2001-03-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75619ltr.pdf
2000-11-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75620ltr.pdf
2000-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75621ltr.pdf
2000-08-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75621ta.pdf
2004-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75622TA.pdf
2004-06-04 00:00:00
30965 1 075627 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75627ltr.pdf
2001-03-28 00:00:00
30966 1 075630 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75630ta.pdf
2005-04-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75632ltr.pdf
2000-09-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75634ltr.pdf
2000-08-22 00:00:00
30969 1 075634 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75634ta.pdf
2004-06-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75641ltr.pdf
2000-10-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75642ltr.pdf
2000-12-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75643ltr.pdf
2000-11-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75646ltr.pdf
2000-10-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75656ltr.pdf
2001-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75657ltr.pdf
2001-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75658ta.pdf
2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75660_Milrinone
%20Lactate_Approv.pdf 2003-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75661_Ibuprofen_Approv
.pdf 2003-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75663ltr.pdf
2000-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75665ltrTA.pdf
2000-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf
2001-02-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf
2001-02-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75666ltr.pdf
2000-05-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75671ta.pdf
2004-06-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75672ta.pdf
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75673ltr.pdf
2001-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75684ltr.pdf
2001-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75686ltr.pdf
2001-01-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75689ltr.pdf
2001-03-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75693ltr.pdf
2001-01-26 00:00:00
30991 1 075702 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn
%20Sodium_Approv.pdf 2001-07-03 00:00:00
30992 1 075704 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704ltr.pdf
2001-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704TA.pdf
2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75705ltr.pdf
2001-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75708TA.pdf
2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75709ltr.pdf
2001-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75709TA.pdf
2004-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75718ltr.pdf
2001-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75719 APltr.pdf
2006-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75727ltr.pdf
2004-06-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75731ltr.pdf
2000-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75738ltr.pdf
2001-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75747TA.pdf
2004-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75747ltr.pdf
2004-06-15 00:00:00
31005 1 075750 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75750ltr.pdf
2004-06-02 00:00:00
31006 1 075752 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75752ltr.pdf
2003-04-15 00:00:00
31007 1 075753 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75753.ta.pdf
2003-04-10 00:00:00
31008 1 075755 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75755ltr.pdf
2001-08-02 00:00:00
31010 1 075761 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75761.TA.pdf
2003-04-15 00:00:00
31011 1 075762 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75762TA.pdf
2004-06-10 00:00:00
31012 1 075765 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75765.ap.pdf
2003-04-15 00:00:00
31013 1 075768 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75768ltr.pdf
2000-09-25 00:00:00
31014 1 075773 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75773.TA.pdf
2003-04-15 00:00:00
31015 1 075780 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75780.ap.pdf
2003-04-15 00:00:00
31016 1 075783 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75783TA2.pdf
2004-06-24 00:00:00
31017 1 075786 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75786TA.pdf
2004-06-04 00:00:00
31018 1 075790 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75790TA.pdf
2004-06-08 00:00:00
31019 1 075792 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75792ltr.pdf
2000-08-29 00:00:00
31020 1 075795 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75795ltr.pdf
2001-06-13 00:00:00
31021 1 075805 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75805ltr.pdf
2001-04-16 00:00:00
31022 1 075806 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75806ta.pdf
2004-06-10 00:00:00
31023 1 075810 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75810ta.pdf
2003-04-15 00:00:00
31024 1 075811 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75811ltr.pdf
2001-04-26 00:00:00
31025 1 075812 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75812ltr.pdf
2001-06-15 00:00:00
31026 1 075813 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75813TA.pdf
2001-04-16 00:00:00
31027 1 075818 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75818.ap.pdf
2003-04-15 00:00:00
31028 1 075818 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75818TA.pdf
2004-06-04 00:00:00
31029 1 075820 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75820.ap.pdf
2003-04-15 00:00:00
31030 1 075822 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75822Altr.pdf
2003-02-10 00:00:00
31031 1 075826 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75826Approval.pdf
2003-04-15 00:00:00
31032 1 075830 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75830tadf.pdf
2003-04-15 00:00:00
31033 1 075830 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75830_Milrinone
%20Lactate_Approv.pdf 2003-12-24 00:00:00
31034 1 075839 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-839_Minoxidil.pdf
2002-01-17 00:00:00
31035 1 075848 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75848ltr.pdf
2001-02-09 00:00:00
31036 1 075850 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75850ltr.pdf
2001-04-27 00:00:00
31037 1 075861 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75861ltr.pdf
2001-06-22 00:00:00
31038 1 075863 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75863.ta.pdf
2003-04-15 00:00:00
31039 1 075863 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75863.ap.pdf
2003-04-10 00:00:00
31040 1 075872 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75872TA.pdf
2004-06-04 00:00:00
31041 1 075881 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75881ltr.pdf
2001-03-29 00:00:00
31042 1 075887 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75887ltr.pdf
2001-01-05 00:00:00
31043 1 075889 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75889ltr.pdf
2000-11-29 00:00:00
31044 1 075890 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75890.ta.pdf
2003-04-10 00:00:00
31045 1 075896 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75896ltr.pdf
2004-11-08 00:00:00
31046 1 075916 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75916.apdF.pdf
2003-04-16 00:00:00
31047 1 075928 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75928.ta.pdf
2003-04-10 00:00:00
31048 1 075932 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf
2004-03-24 00:00:00
31049 1 075945 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75945ltr.pdf
2002-11-08 00:00:00
31050 1 075951 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75951ltr.pdf
2001-05-25 00:00:00
31051 1 075960 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75960ltr.pdf
2002-06-19 00:00:00
31052 1 075962 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75962ltr.pdf
2002-06-24 00:00:00
31053 1 075964 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75964ltr.pdf
2002-06-19 00:00:00
31054 1 075974 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74974ltr.pdf
1998-07-23 00:00:00
31055 1 075977 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75977ltr.pdf
2002-06-19 00:00:00
31056 1 075986 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75986ltr.pdf
2002-06-21 00:00:00
31057 1 075994 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75994TA.pdf
2004-06-08 00:00:00
31058 1 075995 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75995AP.pdf
2003-04-10 00:00:00
31059 1 076005 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76005_Econazole
Nirate_Approv.pdf 2003-12-24 00:00:00
31060 1 076007 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76007ltr.pdf
2004-06-08 00:00:00
31061 1 076018 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76018_Amiodarone
%20Hydrochloride_Approv.pdf 2003-12-24 00:00:00
31062 1 076019 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76019ltr.pdf
2004-03-19 00:00:00
31063 1 076038 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76038.APF.pdf
2003-04-10 00:00:00
31064 1 076047 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076047ltr.pdf
2008-01-09 00:00:00
31065 1 076050 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76050APltr.pdf
2004-06-08 00:00:00
31066 1 076052 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076052s000LTR.pdf
2006-06-27 00:00:00
31067 1 076058 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76058.apd.pdf
2003-04-10 00:00:00
31068 1 076062 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076062s000ltr.pdf
2007-05-01 00:00:00
31069 1 076068 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76068ltr.pdf
2004-10-04 00:00:00
31070 1 076075 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76075_Econazole
%20Nitrate_Approv.pdf 2004-04-13 00:00:00
31071 1 076077 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76077ltr.pdf
2004-07-30 00:00:00
31072 1 076086 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76086ltr.pdf
2004-07-30 00:00:00
31073 1 076089 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76089ltr.pdf
2004-06-15 00:00:00
31074 1 076093 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76093.ta.pdf
2003-04-16 00:00:00
31075 1 076095 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76095ltr.pdf
2002-07-10 00:00:00
31076 1 076101 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76101d.taF.pdf
2003-04-16 00:00:00
31077 1 076113 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76113tadF.pdf
2003-04-10 00:00:00
31078 1 076118 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76118ltr.pdf
2004-02-12 00:00:00
31079 1 076119 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76119tapd.pdf
2004-06-24 00:00:00
31080 1 076121 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76121d.apf.pdf
2003-04-16 00:00:00
31081 1 076122 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76122tapd.pdf
2003-04-10 00:00:00
31082 1 076124 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76124s000ltr.pdf
2007-03-05 00:00:00
31083 1 076126 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76126ltr.pdf
2004-06-15 00:00:00
31084 1 076134 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76134.ta.pdf
2003-04-16 00:00:00
31085 1 076136 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76136.ta.pdf
2003-04-16 00:00:00
31086 1 076136 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76136ltr.pdf
2004-06-15 00:00:00
31087 1 076138 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76138ltr.pdf
2004-06-15 00:00:00
31088 1 076153 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.AP.pdf
2003-04-10 00:00:00
31089 1 076153 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.TA.pdf
2003-04-11 00:00:00
31090 1 076162 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76162ltr.pdf
2004-10-18 00:00:00
31091 1 076164 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76164ltr.pdf
2003-04-11 00:00:00
31092 1 076165 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76165apf.pdf
2003-04-11 00:00:00
31093 1 076168 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76168ltr.pdf
2004-03-26 00:00:00
31094 1 076170 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76170_Lithium
%20Carbonate_Approv.pdf 2004-06-08 00:00:00
31095 1 076175 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76175.ap.pdf
2003-04-11 00:00:00
31096 1 076184 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076184s000ltr.pdf
2008-02-07 00:00:00
31097 1 076192 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76192ltr.pdf
2004-04-07 00:00:00
31098 1 076208 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76208ltr.pdf
2004-01-29 00:00:00
31099 1 076213 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76213ltr.pdf
2004-07-30 00:00:00
31100 1 076221 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076221s000ltr.pdf
2009-11-09 00:00:00
31101 1 076228 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076228s000ltr.pdf
2008-07-02 00:00:00
31102 1 076235 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76235ltr.pdf
2004-10-15 00:00:00
31103 1 076250 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076250ltr.pdf
2005-04-28 00:00:00
31104 1 076258 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-
258.rescind.ltr.pdf 2004-06-24 00:00:00
31105 1 076258 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076258ltr.pdf
2005-02-01 00:00:00
31106 1 076268 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76268_Digoxin_Approv.p
df 2003-12-24 00:00:00
31107 1 076276 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76276ltr.pdf
2004-10-18 00:00:00
31108 1 076303 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76303ltr.pdf
2004-07-30 00:00:00
31109 1 076313 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076313ltr.pdf
2005-03-30 00:00:00
31110 1 076333 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76333ltr.pdf
2004-02-12 00:00:00
31111 1 076340 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076340s000LTR.pdf
2006-06-20 00:00:00
31112 1 076374 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76374.ltr.pdf
2004-04-07 00:00:00
31113 1 076377 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076377s000_ltr.pdf
2007-07-05 00:00:00
31114 1 076378 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076378ltr.pdf
2005-04-28 00:00:00
31115 1 076388 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076388s000ltr.pdf
2006-09-18 00:00:00
31116 1 076390 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076390s000_ltr.pdf
2007-07-05 00:00:00
31117 1 076394 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76394_Amiodarone
Hydrochloride_Approv.pdf 2003-12-24 00:00:00
31118 1 076402 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76402ltr.pdf
2004-02-27 00:00:00
31119 1 076420 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076420s000LTR.pdf
2008-06-28 00:00:00
31120 1 076432 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76432ltr.pdf
2004-07-30 00:00:00
31121 1 076435 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076435ltr.pdf
2005-01-11 00:00:00
31122 1 076436 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076436s000LTR.pdf
2006-08-04 00:00:00
31123 1 076445 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076445s000ltr.pdf
2007-05-01 00:00:00
31124 1 076446 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76446 AP_ltr.pdf
2006-03-23 00:00:00
31125 1 076468 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076468ltr.pdf
2005-04-28 00:00:00
31126 1 076475 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/07647ltr.pdf
2005-04-28 00:00:00
31127 1 076477 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076477Orig1s000ltr.pdf
2011-12-01 00:00:00
31128 1 076489 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076489ltr.pdf
2005-04-28 00:00:00
31129 1 076491 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76491ltr.pdf
2004-06-24 00:00:00
31130 1 076493 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76493ltr.pdf
2004-07-30 00:00:00
31131 1 076500 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76500ltr.pdf
2004-06-16 00:00:00
31132 1 076501 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76501ltr.pdf
2004-06-16 00:00:00
31134 1 076513 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76513ltr.pdf
2004-05-26 00:00:00
31135 1 076518 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76518ltrpdf.pdf
2004-03-19 00:00:00
31136 1 076530 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076530ltr.pdf
2005-04-28 00:00:00
31137 1 076549 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076549ltr.pdf
2005-10-27 00:00:00
31138 1 076564 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76564ltr.pdf
2004-06-16 00:00:00
31139 1 076565 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076565s000ltr.pdf
2010-07-02 00:00:00
31140 1 076568 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76568,76569ltr.pdf
2004-07-30 00:00:00
31141 1 076569 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76568,76569ltr.pdf
2004-07-30 00:00:00
31142 1 076572 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076572s000ltr.pdf
2009-02-13 00:00:00
31143 1 076608 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76608ltr.pdf
2004-12-08 00:00:00
31144 1 076612 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76612ltr.pdf
2004-02-12 00:00:00
31145 1 076629 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076629s000ltr.pdf
2010-03-22 00:00:00
31146 1 076635 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076635ltr.pdf
2005-11-01 00:00:00
31147 1 076640 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076640s000ltr.pdf
2007-05-29 00:00:00
31148 1 076642 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642
s005ltr.pdf 2007-10-22 00:00:00
31149 1 076642 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642
s005ltr.pdf 2007-10-22 00:00:00
31150 1 076644 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076644s000LTR.pdf
2006-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076649s000_ltr.pdf
2007-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076654lt.pdf
2005-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76665ltr.pdf
2004-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076683ltr.pdf
2005-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076702s000LTR.pdf
2006-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076737ltr.pdf
2006-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76746ltr.pdf
2004-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76751ltr.pdf
2004-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76754ltr.pdf
2004-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076759s000ltr.pdf
2006-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076761ltr.pdf
2006-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076765s000TAltr.pdf
2011-05-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76766ltr.pdf
2004-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076773ltr.pdf
2005-03-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076784s000ltr.pdf
2009-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076811ltr.pdf
2005-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76815ltr.pdf
2004-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076822Orig1s000ltr.pdf
2013-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76851ltr.pdf
2004-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76858ltr.pdf
2004-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076867s000ltr.pdf
2007-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76885TAltr.pdf
2006-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076885Orig1s000ltr.pdf
2013-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076886s000ltr.pdf
2007-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076897ltr.pdf
2006-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76934APltr.pdf
2006-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076941s000ltr.pdf
2008-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076958s001ltr.pdf
2010-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76962ltr.pdf
2004-09-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076969s002,
s003ltr.pdf 2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076989s000_ltr.pdf
2007-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076993s000ltr.pdf
2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076994ltr.pdf
2004-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076999Orig1s000ltr.pdf
2012-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077007ltr.pdf
2006-02-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077015s000ltr.pdf
2006-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77019LTR.pdf
2004-12-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77036ltr.pdf
2004-10-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077039ltr.pdf
2005-02-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077043ltr.pdf
2004-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077053ltr.pdf
2005-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077059ltr.pdf
2008-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077084ltr.pdf
2005-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077085ltr.pdf
2005-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077086ltr.pdf
2005-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077094TA_ltr.pdf
2005-10-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077107s000ltr.pdf
2007-02-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077111s000ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077130s000ltr.pdf
2007-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077131s000ltr.pdf
2007-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077165TA_ltr.pdf
2005-08-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077170_s000ltr.pdf
2008-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077171ltr.pdf
2005-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077171s006ltr.pdf
2009-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077195s000_ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077206TA_ltr.pdf
2005-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077219s000ltr.pdf
2008-02-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077237TA_ltr.pdf
2005-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077239s000ltr.pdf
2008-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77244ltr.pdf
2004-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077255s000ltr.pdf
2009-11-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077267ltr.pdf
2005-09-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077268TA_ltr.pdf
2005-09-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077270ltr.pdf
2005-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077273s000ltr.pdf
2007-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077284s000ltr.pdf
2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077288s000ltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077295ltr.pdf
2005-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077302s000ltr.pdf
2012-06-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077304s000ltr.pdf
2006-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077312s000ltr.pdf
2009-11-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077316s000_ltr.pdf
2007-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077322s000ltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077332s000TAltr.pdf
2006-10-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077346s000ltr.pdf
2007-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077351s000LTR.pdf
2006-09-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077355ltr.pdf
2008-03-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077359s000ltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077361s000LTR.pdf
2006-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077363TA_rev2.pdf
2006-01-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077366ltr.pdf
2005-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077380s000ltr.pdf
2012-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077391ltr.pdf
2006-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077394ltr.pdf
2005-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf
2007-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077416s000TAltr .pdf
2006-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077425Orig1s000ltr.pdf
2013-09-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077429 2005-
06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077431s000ltr.pdf
2011-04-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77458ltr.pdf
2006-03-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077460s000ltr.pdf
2008-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077463s000TAltr.pdf
2006-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077463s000ltr.pdf
2009-09-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077472s000TAltr.pdf
2006-11-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077477s000ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077481ltr.pdf
2007-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000ltr.pdf
2007-08-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077489s000ltr.pdf
2006-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077492Orig1s000ltr.pdf
2014-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77496ltr.pdf
2006-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077498ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077499ltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077510s000ltr.pdf
2006-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077512s000TAltr.pdf
2011-05-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077519s000ltr.pdf
2008-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077521ta_ltr.pdf
2005-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077527s000ltr.pdf
2008-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077528s000ltr.pdf
2012-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077532s000ltr.pdf
2008-05-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077533s000_ltr.pdf
2007-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077540s000ltr.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077560_TA_ltr.pdf
2007-05-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077567s000ltr.pdf
2009-02-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077605s000ltr.pdf
2008-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077614s000_ltr.pdf
2007-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077623s000ltr.pdf
2007-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077626s000ltr.pdf
2008-06-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077636rev2.pdf
2005-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077639ltr.pdf
2005-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077644ltr.pdf
2005-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077648ltr.pdf
2005-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077660s000ltr.pdf
2007-08-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/77672TA_ltr.pdf
2005-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077672s000TAltr.pdf
2006-07-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077672s000ltr.pdf
2008-12-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077677s001ltr.pdf
2010-01-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077687s000ltr.pdf
2007-09-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077693s000ltr.pdf
2008-01-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/77695TA_ltr.pdf
2005-11-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077702TA.pdf
2006-01-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077724s000ltr.pdf
2008-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077728s000TAltr.pdf
2008-01-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077728s000ltr.pdf
2008-02-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077732s000ltr.pdf
2010-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077742Orig1s000ltr.pdf
2012-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077744s000ltr.pdf
2009-08-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077745s000ltr.pdf
2012-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077780s000_ltr.pdf
2007-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077782s000ltr.pdf
2006-09-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077794s000ltr.pdf
2007-10-10 00:00:00
31291 1 077827 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077827s001ltr.pdf
2008-01-09 00:00:00
31292 1 077846 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077846s000ltr.pdf
2008-10-29 00:00:00
31293 1 077847 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077847s000ltr.pdf
2008-11-03 00:00:00
31294 1 077868 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077868s000ltr.pdf
2009-04-21 00:00:00
31295 1 077873 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077873s000_ltr.pdf
2007-07-05 00:00:00
31296 1 077882 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077882s000ltr.pdf
2009-05-18 00:00:00
31297 1 077884 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077884s000ltr.pdf
2007-05-01 00:00:00
31298 1 077887 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077887s000ltr.pdf
2007-09-11 00:00:00
31299 1 077888 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077888s000ltr.pdf
2008-03-19 00:00:00
31300 1 077920 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77920ltr.pdf
2006-07-21 00:00:00
31301 1 077921 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077921s000ltr.pdf
2009-05-18 00:00:00
31302 1 077923 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077923s000ltr.pdf
2009-05-18 00:00:00
31303 1 077930 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77930ltr.pdf
2006-07-21 00:00:00
31304 1 077932 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77932ltr.pdf
2006-07-21 00:00:00
31305 1 077934 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77934ltr.pdf
2006-07-21 00:00:00
31306 1 077935 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77935ltr.pdf
2006-07-21 00:00:00
31307 1 077936 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077936s000ltr.pdf
2006-07-21 00:00:00
31308 1 077937 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77937ltr.pdf
2006-07-21 00:00:00
31309 1 077944 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77944ltr.pdf
2006-07-21 00:00:00
31310 1 077950 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077950s000TAltr.pdf
2006-07-03 00:00:00
31311 1 077954 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077954s000ltr.pdf
2008-05-05 00:00:00
31312 1 077954 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077954s000ltr.pdf
2009-05-06 00:00:00
31313 1 077973 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077973s000ltr.pdf
2009-07-09 00:00:00
31314 1 077975 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077975s000ltr.pdf
2009-12-24 00:00:00
31315 1 077980 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077980s000TAltr.pdf
2006-06-28 00:00:00
31316 1 077983 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077983s000ltr.pdf
2011-02-02 00:00:00
31317 1 077989 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077989s000ltr.pdf
2007-08-07 00:00:00
31318 1 078004 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078004Orig1s000ltr.pdf
2012-05-18 00:00:00
31319 1 078016 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078016s000ltr.pdf
2007-05-01 00:00:00
31320 1 078022 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078022s000ltr.pdf
2007-02-23 00:00:00
31321 1 078024 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078024s000ltr.pdf
2008-03-19 00:00:00
31322 1 078027 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078027Orig1s000ltr.pdf
2015-07-10 00:00:00
31323 1 078032 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078032s000TAltr.pdf
2011-05-10 00:00:00
31324 1 078052 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078052s000ltr.pdf
2007-08-07 00:00:00
31325 1 078055 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078055s000ltr.pdf
2007-05-01 00:00:00
31326 1 078058 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078058s000ltr.pdf
2010-06-30 00:00:00
31327 1 078080 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078080Orig1s005ltr.pdf
2014-09-24 00:00:00
31328 1 078088 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078088TAltr.pdf
2007-09-25 00:00:00
31329 1 078090 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090
Orig1s005,078522Orig1s005ltr.pdf 2014-09-24 00:00:00
31330 1 078096 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090
Orig1s005,078522Orig1s005ltr.pdf 2014-09-24 00:00:00
31331 1 078098 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078098s000ltr.pdf
2008-09-23 00:00:00
31332 1 078109 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078109s000ltr.pdf
2011-10-26 00:00:00
31333 1 078119 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078119s000TAltr.pdf
2006-11-07 00:00:00
31334 1 078124 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078124s000ltr.pdf
2007-09-25 00:00:00
31335 1 078126 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078126s000ltr.pdf
2007-08-07 00:00:00
31336 1 078131 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078131s000ltr.pdf
2007-09-06 00:00:00
31337 1 078138 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078138s000ltr.pdf
2009-11-13 00:00:00
31338 1 078148 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078148s000ltr.pdf
2010-12-07 00:00:00
31339 1 078157 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078157s000_ltr.pdf
2007-07-05 00:00:00
31340 1 078179 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078179s000ltr.pdf
2010-10-20 00:00:00
31341 1 078182 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078182s000ltr.pdf
2008-08-05 00:00:00
31342 1 078183 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078183s000LTR.pdf
2007-03-31 00:00:00
31343 1 078185 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078185s000ltr.pdf
2009-02-03 00:00:00
31344 1 078189 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078189ltr.pdf
2008-10-03 00:00:00
31345 1 078195 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078195s000TAltr.pdf
2006-08-18 00:00:00
31346 1 078215 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078215s000ltr.pdf
2011-04-04 00:00:00
31347 1 078227 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078227s000_ltr.pdf
2007-09-07 00:00:00
31348 1 078229 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078229s000_ltr.pdf
2007-07-05 00:00:00
31349 1 078241 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078241s000ltr.pdf
2009-08-14 00:00:00
31350 1 078251 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078251s000_ltr.pdf
2007-09-07 00:00:00
31351 1 078252 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078252s000ltr.pdf
2008-03-19 00:00:00
31352 1 078277 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078277s000ltr.pdf
2007-08-07 00:00:00
31353 1 078284 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078284s000ltr.pdf
2009-08-14 00:00:00
31354 1 078290 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078290s000ltr.pdf
2008-08-05 00:00:00
31355 1 078317 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078317ltr.pdf
2008-01-09 00:00:00
31356 1 078322 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078322s000ltr.pdf
2010-06-30 00:00:00
31357 1 078340 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078340Orig1s000ltr.pdf
2015-12-08 00:00:00
31358 1 078343 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078343s000ltr.pdf
2008-01-17 00:00:00
31359 1 078350 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078350Orig1s000ltr.pdf
2015-12-09 00:00:00
31360 1 078357 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/78357Ltr.pdf
2010-03-30 00:00:00
31361 1 078367 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078367s000ltr.pdf
2010-07-14 00:00:00
31362 1 078388 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078388s000ltr.pdf
2011-05-13 00:00:00
31363 1 078392 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297
Orig1s016,078392Orig1s017ltr.pdf 2014-09-24 00:00:00
31364 1 078395 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078395s000ltr.pdf
2008-11-03 00:00:00
31365 1 078399 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078399s000ltr.pdf
2009-11-10 00:00:00
31366 1 078427 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078427ltr.pdf.pdf
2008-01-09 00:00:00
31367 1 078434 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078434s000ltr.pdf
2009-11-12 00:00:00
31368 1 078509 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078509s000TAltr.pdf
2007-03-31 00:00:00
31369 1 078519 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078519s000ltr.pdf
2008-12-02 00:00:00
31370 1 078545 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078545s000ltr.pdf
2009-06-24 00:00:00
31371 1 078548 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078548s000ltr.pdf
2010-03-03 00:00:00
31372 1 078560 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078560Orig1s000ltr.pdf
2015-06-29 00:00:00
31373 1 078567 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078567s000ltr.pdf
2007-09-25 00:00:00
31374 1 078572 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078572s000ltr.pdf
2010-03-25 00:00:00
31375 1 078576 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078576Orig1s000ltr.pdf
2013-03-04 00:00:00
31376 1 078587 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078587s000TA_ltr.pdf
2008-01-09 00:00:00
31377 1 078615 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078615ltr.pdf
2008-01-09 00:00:00
31378 1 078633 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078633s000ltr.pdf
2009-10-14 00:00:00
31379 1 078644 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078644s000TAltr.pdf
2007-07-16 00:00:00
31380 1 078648 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078648Orig1s000ltr.pdf
2013-03-01 00:00:00
31381 1 078702 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078702Orig1s000ltr.pdf
2013-05-07 00:00:00
31382 1 078709 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078709Orig1s000ltr.pdf
2016-04-05 00:00:00
31383 1 078717 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078717s000ltr.pdf
2008-12-02 00:00:00
31384 1 078723 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078723Orig1s000ltr.pdf
2012-08-06 00:00:00
31385 1 078743 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078743s000ltr.pdf
2009-03-10 00:00:00
31386 1 078751 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078751s000ltr.pdf
2010-07-09 00:00:00
31387 1 078773 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078773s000ltr.pdf
2011-12-01 00:00:00
31388 1 078777 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078777s000TAltr.pdf
2011-05-10 00:00:00
31389 1 078804 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078804s000ltr.pdf
2009-08-21 00:00:00
31390 1 078818 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078818Orig1s002ltr.pdf
2013-03-22 00:00:00
31391 1 078854 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078854s000ltr.pdf
2011-06-09 00:00:00
31392 1 078857 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf
2014-06-02 00:00:00
31393 1 078864 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078864s000ltr.pdf
2008-05-21 00:00:00
31394 1 078872 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078872s000ltr.pdf
2009-09-23 00:00:00
31395 1 078883 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078883s000ltr.pdf
2008-04-28 00:00:00
31396 1 078886 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078886_TA_PEPFAR_LTR.p
df 2008-03-04 00:00:00
31397 1 078907 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078907s000ltr.pdf
2009-11-05 00:00:00
31398 1 078908 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078908Orig1s000ltr.pdf
2013-12-05 00:00:00
31399 1 078958 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078958TAltr_rc.pdf
2008-01-09 00:00:00
31400 1 078979 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078979s000ltr.pdf
2009-01-27 00:00:00
31401 1 078984 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078984s000ltr.pdf
2010-06-30 00:00:00
31402 1 079007 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079007s000ltr.pdf
2010-06-30 00:00:00
31403 1 079013 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079013s000ltr.pdf
2011-07-20 00:00:00
31404 1 079014 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079014s000ltr.pdf
2011-07-20 00:00:00
31405 1 079046 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf
2010-12-22 00:00:00
31406 1 079051 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079051s000ltr.pdf
2008-07-31 00:00:00
31407 1 079056 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079056s000ltr.pdf
2011-07-20 00:00:00
31408 1 079075 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079075s000ltr.pdf
2010-06-24 00:00:00
31409 1 079079 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/079079TAs000ltr.pdf
2008-01-09 00:00:00
31410 1 079107 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079107s000ltr.pdf
2009-01-21 00:00:00
31411 1 079108 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf
2013-12-05 00:00:00
31412 1 079110 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079110s000ltr.pdf
2009-07-09 00:00:00
31413 1 079120 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079120s000ltr.pdf
2009-01-21 00:00:00
31414 1 079124 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079124s000ltr.pdf
2008-04-28 00:00:00
31415 1 079132 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/079132Orig1s000Approv.pdf
2012-02-14 00:00:00
31416 1 079142 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/079142Orig1s000ltr.pdf
2012-08-06 00:00:00
31417 1 079161 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079161Orig1s000ltr.pdf
2016-07-20 00:00:00
31418 1 079166 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079166Orig1s000ltr.pdf
2016-07-20 00:00:00
31419 1 079167 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079167Orig1s000ltr.pdf
2016-05-03 00:00:00
31420 1 079168 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079168Orig1s000ltr.pdf
2016-07-20 00:00:00
31421 1 079170 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079170s000ltr.pdf
2010-05-17 00:00:00
31422 1 079172 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079172Orig1s000ltr.pdf
2016-07-20 00:00:00
31423 1 079183 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079183s000ltr.pdf
2009-02-24 00:00:00
31424 1 079185 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079185s000ltr.pdf
2009-07-09 00:00:00
31425 1 079188 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079188s000ltr.pdf
2008-12-19 00:00:00
31426 1 079244 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079244s000ltr.pdf
2009-05-05 00:00:00
31427 1 084349 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084349Orig1s067ltr.pdf
2012-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084349Orig1s074ltr.pdf
2015-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084427Orig1s026ltr.pdf
2012-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084427Orig1s028ltr.pdf
2013-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087294Orig1s026ltr.pdf
2014-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/088617Orig1s043,088618
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/088764Orig1s084ltr.pdf
2013-09-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf
1998-10-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf
1998-10-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090011Orig1s000ltr.pdf
2013-04-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090017s000ltr.pdf
2009-11-23 00:00:00
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2014-07-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090040TAltr.pdf
2011-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090041Orig1s000Ltr.pdf
2016-02-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090043Orig1s000Ltr.pdf
2016-02-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090044s000ltr.pdf
2010-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090048s000ltr.pdf
2010-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090051Orig1s000ltr.pdf
2016-02-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090073Orig1s000ltr.pdf
2016-02-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090081s000ltr.pdf
2010-03-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090094_PEPFAR_APLetter
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090095s000ltr.pdf
2010-12-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf
2015-11-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090166s000ltr.pdf
2009-06-02 00:00:00
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2015-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090229s000ltr.pdf
2010-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090240s000ltr.pdf
2010-01-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090254s000ltr.pdf
2008-04-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090270s000ltr.pdf
2009-06-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090300s000ltr.pdf
2008-10-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090323s000ltr.pdf
2012-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090372s000ltr.pdf
2010-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090377s000ltr.pdf
2010-03-04 00:00:00
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2016-05-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s010ltr.pdf
2016-05-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090433s000ltr.pdf
2009-03-19 00:00:00
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2009-08-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090449Orig1s000ltr.pdf
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2009-08-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090466Orig1s000ltr.pdf
2015-06-18 00:00:00
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2016-04-19 00:00:00
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2009-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090482Orig1s000ltr.pdf
2017-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090488s000ltr.pdf
2009-01-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090490s000ltr.pdf
2009-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090519s000ltr.pdf
2009-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090539s000ltr.pdf
2010-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090600s000ltr.pdf
2009-10-14 00:00:00
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2010-03-29 00:00:00
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2012-08-24 00:00:00
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2010-01-15 00:00:00
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2012-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090685s000ltr.pdf
2009-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090688s000ltr.pdf
2009-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090694Orig1s000ltr.pdf
2013-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090704Orig1s000ltr.pdf
2012-12-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090732s000ltr.pdf
2010-06-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090763s000ltr.pdf
2009-11-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090776Orig1s000ltr.pdf
2013-12-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090783Orig1s000ltr.pdf
2013-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090786Orig1s000ltr.pdf
2012-12-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090798Orig1s000ltr.pdf
2012-04-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090811Orig1s000ltr.pdf
2015-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090816Orig1s000ltr.pdf
2015-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090819Orig1s000ltr.pdf
2015-02-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090824s000ltr.pdf
2010-07-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090825s000ltr.pdf
2011-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090844Orig1s000ltr.pdf
2012-05-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090848Orig1s000ltr.pdf
2015-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090896s000ltr.pdf
2009-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090924s000ltr.pdf
2010-01-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090954s000ltr.pdf
2009-12-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090960s000ltr.pdf
2012-03-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090982Orig1s000ltr.pdf
2016-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090984Orig1s000ltr.pdf
2012-08-07 00:00:00
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2012-05-18 00:00:00
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2014-04-16 00:00:00
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2010-05-17 00:00:00
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2015-06-02 00:00:00
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2013-09-04 00:00:00
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2016-03-24 00:00:00
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2011-04-01 00:00:00
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2012-07-05 00:00:00
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2014-07-15 00:00:00
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2011-10-03 00:00:00
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2012-06-20 00:00:00
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2011-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091382Orig1s000ltr.pdf
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2013-04-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091464Orig1s000ltr.pdf
2014-04-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091471Orig1s000ltr.pdf
2016-02-19 00:00:00
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2012-05-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091479Orig1s000ltr.pdf
2012-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091496Orig1s000ltr.pdf
2013-09-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091514Orig1s000ltr.pdf
2015-06-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091517Orig1s000ltr.pdf
2015-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091576Orig1s000ltr.pdf
2012-08-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091577s000ltr.pdf
2011-05-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091579s000ltr.pdf
2011-08-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091589Orig1s000ltr.pdf
2013-10-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091593s000ltr.pdf
2012-02-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091673Orig1s000ltr.pdf
2014-04-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/101063s5081LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botaller122100L.htm
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5189ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103000s5232ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5311ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5312ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5370ltr.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5030ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103946Orig1s5097ltr.pd
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0092ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125019s132ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125019s0194ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125031s072LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s180ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125057_0016ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0046ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s060LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s108_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s114ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s128ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s161ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125057s0196ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s0213ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s327ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s367ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s393ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s297ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s301ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s308ltr.pdf
2015-05-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125103_0000_ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125103s0010ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125103Orig1s146ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125103Orig1s171,s172lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125104s015LTR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125104s576ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125104Orig1s950ltr.pdf
2015-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125117Orig1s111ltr.pdf
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2011-08-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125118s0138ltr.pdf
2012-02-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125141s074ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125141Orig1s219ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s194ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125156s053ltr.pdf
2010-07-02 00:00:00
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2015-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s003ltr.pdf
2015-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s004s006ltr
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125522Orig1s000ltr.pdf
2015-09-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125544Orig1s000ltr.pdf
2016-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s007ltr.pdf
2016-01-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s012ltr.pdf
2015-11-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s019ltr.pdf
2016-05-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125559Orig1s000ltr.pdf
2015-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200043s000ltr.pdf
2012-06-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf
2011-10-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s006ltr.pdf
2012-02-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s007ltr.pdf
2012-01-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s012ltr_rev
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200045Orig1s014ltr.pdf
2013-11-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s016ltr.pdf
2015-04-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200063Orig1s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200068Orig1s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200156Orig1s000.pdf
2013-06-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s012ltr.pdf
2012-12-11 00:00:00
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2013-07-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200179s000ltr.pdf
2010-06-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200179Orig1s003ltr.pdf
2015-09-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200199Orig1s003ltr.pdf
2014-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200271Orig1s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200327s000ltr.pdf
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2013-05-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s011ltr.pdf
2013-12-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200327Orig1s016,s017lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200465Orig1s000ltr.pdf
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2011-08-29 00:00:00
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2012-08-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s002ltr.pdf
2012-07-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200533Orig1s004ltr.pdf
2013-04-18 00:00:00
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2014-04-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s011ltr.pdf
2014-08-20 00:00:00
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2015-07-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200534s000ltr.pdf
2010-10-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200535s000ltr.pdf
2010-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200582s000ltr.pdf
2011-02-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200582Orig1s002ltr.pdf
2016-01-29 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf
2012-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf
2012-04-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Org1s016ltr.pdf
2013-09-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200623s000TAltr.pdf
2011-03-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200624Orig1s000ltr.pdf
2015-07-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200656Orig1s000ltr.pdf
2014-08-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s000ltr.pdf
2015-09-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s002ltr.pdf
2015-10-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200677Orig1s002ltr.pdf
2015-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200678s000ltr.pdf
2010-11-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf
2012-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf
2012-03-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s007ltr.pdf
2012-04-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200678Orig1s010ltr.pdf
2013-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200733s000ltr.pdf
2010-12-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200735Orig1s000ltr.pdf
2014-07-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200738s000ltr.pdf
2011-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200748s000ltr.pdf
2011-01-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200790Orig1s000ltr.pdf
2014-11-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200792Orig1s000ltr.pdf
2014-10-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200793s000ltr.pdf
2010-08-06 00:00:00
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2011-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200795Orig1s004ltr.pdf
2013-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200795Orig1s005ltr.pdf
2014-05-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s000ltr.pdf
2011-03-02 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s001ltr.pdf
2011-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s002ltr.pdf
2011-12-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s006ltr.pdf
2014-08-04 00:00:00
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2013-07-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200881Orig1s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200904Orig1s000ltr.pdf
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2014-02-11 00:00:00
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2014-10-29 00:00:00
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2014-04-25 00:00:00
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2013-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201023Orig1s011ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201023Orig1s015ltr.pdf
2015-06-22 00:00:00
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2013-07-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201094Orig1s000ltr.pdf
2014-04-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201107s000TAltr.pdf
2012-07-09 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201151s000ltr.pdf
2011-09-26 00:00:00
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2014-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201277s000ltr.pdf
2011-03-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201278Orig1s000ltr.pdf
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2011-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004lt
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s004ltr.pdf
2013-09-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201281Orig1s006ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s001ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201586Orig1s000ltr.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201593Orig1s000ltr.pdf
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2013-01-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201635Orig1s000ltr.pdf
2012-06-26 00:00:00
32124 1 201635 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000TA_ltr.
pdf 2013-06-11 00:00:00
32125 1 201635 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201635Orig1s007ltr.pdf
2015-05-13 00:00:00
32126 1 201655 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201655Orig1s000Ltr.pdf
2011-12-09 00:00:00
32127 1 201655 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201655Orig1s004ltr.pdf
2013-01-16 00:00:00
32128 1 201655 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201655Orig1s017ltr.pdf
2015-07-07 00:00:00
32129 1 201655 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s020ltr.pdf
2016-04-22 00:00:00
32130 1 201699 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201699Orig1s004ltr_cor
rected.pdf 2013-04-09 00:00:00
32132 1 201739 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201739Orig1s000ltr.pdf
2012-08-14 00:00:00
32133 1 201739 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201739Orig1s004ltr.pdf
2016-05-19 00:00:00
32134 1 201742 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201742Orig1s000ltr.pdf
2014-02-13 00:00:00
32135 1 201743 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000(1)ltr.pdf
2011-05-12 00:00:00
32136 1 201746 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201746Orig1s000ltr.pdf
2015-06-10 00:00:00
32137 1 201760 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201760Orig1s000ltr.pdf
2016-02-01 00:00:00
32138 1 201803 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201803s000ltr.pdf
2012-06-14 00:00:00
32139 1 201811 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201811Orig1s000ltr.pdf
2015-03-25 00:00:00
32140 1 201820 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201820Orig1s000ltr.pdf
2012-10-16 00:00:00
32141 1 201831 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201831Orig1s000ltr.pdf
2015-05-29 00:00:00
32142 1 201849 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s000ltr.pdf
2015-05-13 00:00:00
32143 1 201917 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201917Orig1s000ltr.pdf
2011-05-23 00:00:00
32144 1 201917 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917s004ltr.pdf
2012-06-25 00:00:00
32145 1 201917 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s008ltr.pdf
2013-04-30 00:00:00
32146 1 201917 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s010,s012lt
r.pdf 2013-10-29 00:00:00
32147 1 201922 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201922Orig1s000ltr.pdf
2012-07-13 00:00:00
32148 1 201923 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201923Orig1s000ltr.pdf
2014-09-29 00:00:00
32149 1 201946 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201946Orig1s000ltr.pdf
2016-07-20 00:00:00
32150 1 202008 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202008Orig1s000ltr.pdf
2012-04-06 00:00:00
32151 1 202012 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202012s000ltr.pdf
2011-11-21 00:00:00
32152 1 202020 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202020Orig1s003ltr.pdf
2013-06-18 00:00:00
32153 1 202022 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202022s000ltr.pdf
2011-05-24 00:00:00
32154 1 202022 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s002ltr.pdf
2012-12-11 00:00:00
32155 1 202022 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s003ltr.pdf
2012-08-15 00:00:00
32156 1 202022 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202022Orig1s009ltr.pdf
2015-05-11 00:00:00
32157 1 202026 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202026Orig1s000ltr.pdf
2013-07-19 00:00:00
32158 1 202051 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202051Orig1s000ltr.pdf
2013-09-03 00:00:00
32159 1 202054 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202054Orig1s000ltr.pdf
2014-09-05 00:00:00
32160 1 202057 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202057Orig1s000ltr.pdf
2012-07-30 00:00:00
32161 1 202057 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s001ltr.pdf
2013-02-04 00:00:00
32162 1 202057 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202057Orig1s006ltr.pdf
2014-02-14 00:00:00
32163 1 202057 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s009ltr.pdf
2013-11-27 00:00:00
32164 1 202058 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202058s000ltr.pdf
2011-10-12 00:00:00
32165 1 202067 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202067Orig1s002,203993
Orig1s002ltr.pdf 2013-11-26 00:00:00
32166 1 202067 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202067Orig1s003,203993
Orig1s003ltr.pdf 2014-12-11 00:00:00
32167 1 202080 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202080s000ltr.pdf
2011-06-28 00:00:00
32168 1 202080 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202080Origs002ltr.pdf
2014-01-17 00:00:00
32169 1 202080 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202080Orig1s003ltr.pdf
2015-01-27 00:00:00
32170 1 202088 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s000ltr.pdf
2011-06-16 00:00:00
32171 1 202088 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s000ltr.pdf
2012-03-29 00:00:00
32172 1 202088 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s002ltr.pdf
2012-03-30 00:00:00
32173 1 202093 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093Orig1s000ltr.pdf
2012-12-28 00:00:00
32174 1 202096 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202096Orig1s000ltr.pdf
2012-08-06 00:00:00
32175 1 202100 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202100Orig1s000ltr.pdf
2012-10-02 00:00:00
32176 1 202100 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s004ltr.pdf
2015-04-20 00:00:00
32177 1 202100 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s005ltr.pdf
2015-07-14 00:00:00
32178 1 202100 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202100Orig1s007ltr.pdf
2016-05-16 00:00:00
32179 1 202102 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202102Orig1s000ltr.pdf
2015-04-29 00:00:00
32180 1 202103 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202103Orig1s000ltr.pdf
2016-06-14 00:00:00
32181 1 202122 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202122Orig1s000TAltr.p
df 2014-08-28 00:00:00
32182 1 202123 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202123s000ltr.pdf
2011-08-12 00:00:00
32183 1 202123 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s003ltr.pdf
2013-01-30 00:00:00
32184 1 202123 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s011ltr.pdf
2013-06-21 00:00:00
32185 1 202123 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s012ltr.pdf
2013-12-17 00:00:00
32186 1 202123 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202123Orig1s020ltr.pdf
2015-05-11 00:00:00
32187 1 202123 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s023ltr.pdf
2016-02-11 00:00:00
32188 1 202129 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202129s000ltr.pdf
2012-01-25 00:00:00
32189 1 202129 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s
006ltr.pdf 2014-10-27 00:00:00
32190 1 202133 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202133s000ltr.pdf
2011-10-12 00:00:00
32191 1 202133 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202133Orig1s003ltr.pdf
2014-07-23 00:00:00
32192 1 202144 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202144Orig1s000ltr.pdf
2014-05-13 00:00:00
32193 1 202148 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202148Orig1s000ltr.pdf
2015-09-15 00:00:00
32194 1 202155 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s002ltr.pdf
2014-02-04 00:00:00
32195 1 202155 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s003ltr.pdf
2014-03-14 00:00:00
32196 1 202155 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202155Orig1s004ltr.pdf
2013-11-06 00:00:00
32197 1 202155 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s010ltr.pdf
2015-06-18 00:00:00
32198 1 202157 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202157s000ltr.pdf
2011-11-29 00:00:00
32199 1 202172 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202172s000ltr.pdf
2011-08-08 00:00:00
32200 1 202172 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202172Orig1s000TAltr.p
df 2016-02-16 00:00:00
32201 1 202191 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202191Orig1s000ltr.pdf
2014-08-19 00:00:00
32202 1 202192 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s006ltr.pdf
2014-07-28 00:00:00
32203 1 202192 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s008ltr.pdf
2014-12-05 00:00:00
32204 1 202192 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s009ltr.pdf
2014-12-16 00:00:00
32205 1 202211 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202211Orig1s000ltr.pdf
2013-01-30 00:00:00
32206 1 202211 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202211Orig1s004ltr.pdf
2016-03-04 00:00:00
32207 1 202212 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202212Orig1s000ltr.pdf
2012-05-03 00:00:00
32208 1 202227 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202227s000ltr.pdf
2012-03-16 00:00:00
32209 1 202229 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202229Orig1s000ltr.pdf
2013-07-18 00:00:00
32210 1 202231 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202231s000ltr.pdf
2011-07-05 00:00:00
32211 1 202236 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236s000ltr.pdf
2012-05-03 00:00:00
32212 1 202236 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236Orig1s001ltr.pdf
2012-08-17 00:00:00
32213 1 202240 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202240Orig1s000ltr.pdf
2015-04-10 00:00:00
32214 1 202245 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202245s001ltr.pdf
2012-04-19 00:00:00
32215 1 202245 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202245Orig1s002ltr.pdf
2013-05-13 00:00:00
32216 1 202258 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s005ltr.pdf
2012-11-06 00:00:00
32217 1 202258 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s006ltr.pdf
2012-12-26 00:00:00
32218 1 202258 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s012ltr.pdf
2014-01-21 00:00:00
32219 1 202258 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s015ltr.pdf
2014-07-29 00:00:00
32220 1 202259 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202259Orig1s000ltr.pdf
2015-12-29 00:00:00
32221 1 202270 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202270Orig1s006ltr.pdf
2014-02-13 00:00:00
32222 1 202270 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044
Orig1s035,202270Orig1s010ltr.pdf 2015-09-01 00:00:00
32223 1 202276 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s006ltr.pdf
2014-04-30 00:00:00
32224 1 202276 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s010ltr.pdf
2015-05-19 00:00:00
32225 1 202278 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202278Orig1s000ltr.pdf
2013-01-22 00:00:00
32226 1 202278 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002lt
r.pdf 2014-03-25 00:00:00
32227 1 202278 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002lt
r.pdf 2014-03-25 00:00:00
32228 1 202292 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202292Orig1s000ltr.pdf
2013-01-02 00:00:00
32229 1 202293 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s008ltr.pdf
2015-12-08 00:00:00
32230 1 202301 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202301Orig1s000ltr.pdf
2012-06-22 00:00:00
32231 1 202317 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202317Orig1s000ltr.pdf
2013-08-27 00:00:00
32232 1 202317 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202317Orig1s004ltr.pdf
2015-11-03 00:00:00
32233 1 202324 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s003ltr.pdf
2014-12-31 00:00:00
32234 1 202331 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202331s000ltr.pdf
2011-12-27 00:00:00
32235 1 202331 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202331Orig1s006ltr.pdf
2014-07-24 00:00:00
32236 1 202331 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202331Orig1s007ltr.pdf
2015-04-17 00:00:00
32237 1 202342 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202342Orig1s002ltr.pdf
2014-12-23 00:00:00
32238 1 202343 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S
004ltr.pdf 2012-09-24 00:00:00
32239 1 202343 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007lt
r.pdf 2012-11-06 00:00:00
32240 1 202343 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007lt
r.pdf 2012-11-06 00:00:00
32241 1 202343 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s008ltr.pdf
2013-10-28 00:00:00
32242 1 202343 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s010ltr.pdf
2013-08-22 00:00:00
32243 1 202343 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202343Orig1s011ltr.pdf
2014-02-26 00:00:00
32244 1 202344 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202344s000ltr.pdf
2012-03-26 00:00:00
32245 1 202344 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s007ltr.pdf
2015-02-27 00:00:00
32246 1 202344 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s008ltr.pdf
2015-04-13 00:00:00
32247 1 202344 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202344Orig1s010ltr.pdf
2016-03-24 00:00:00
32249 1 202379 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202379s000ltr.pdf
2011-05-03 00:00:00
32250 1 202379 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s004ltr.pdf
2012-09-20 00:00:00
32251 1 202379 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s016ltr.pdf
2015-03-24 00:00:00
32252 1 202379 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s021ltr.pdf
2015-12-11 00:00:00
32253 1 202379 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202379Orig1s023ltr.pdf
2016-05-19 00:00:00
32254 1 202385 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202385s000ltr.pdf
2011-12-27 00:00:00
32255 1 202429 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202429Orig1s000ltr.pdf
2011-08-17 00:00:00
32256 1 202429 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003lt
r.pdf 2013-07-05 00:00:00
32257 1 202429 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s004ltr.pdf
2014-03-20 00:00:00
32258 1 202429 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202429Orig1s008ltr.pdf
2015-08-12 00:00:00
32259 1 202435 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202435Orig1s000ltr.pdf
2014-06-23 00:00:00
32260 1 202439 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf
2014-06-03 00:00:00
32261 1 202439 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202439Orig1s012ltr.pdf
2014-02-13 00:00:00
32262 1 202439 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s017ltr.pdf
2016-05-09 00:00:00
32263 1 202450 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202450Orig1s005ltr.pdf
2015-04-06 00:00:00
32264 1 202450 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202450Orig1s006ltr.pdf
2016-03-18 00:00:00
32265 1 202459 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202459Orig1s000ltr.pdf
2013-04-09 00:00:00
32266 1 202489 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202489Orig1s000ltr.pdf
2013-10-11 00:00:00
32267 1 202497 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202497Orig1s000ltr.pdf
2012-08-10 00:00:00
32268 1 202503 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202503Orig1s000ltr.pdf
2012-11-07 00:00:00
32269 1 202513 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202513Orig1s003ltr_rep
lacement.pdf 2013-01-11 00:00:00
32270 1 202515 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202515s000ltr.pdf
2011-11-28 00:00:00
32271 1 202517 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202517Orig1s002ltr.pdf
2014-09-04 00:00:00
32272 1 202521 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202521Orig1s000ltr.pdf
2015-10-14 00:00:00
32273 1 202552 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202552Orig1s000ltr.pdf
2015-12-29 00:00:00
32274 1 202565 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202565Orig1s000ltr.pdf
2015-05-11 00:00:00
32275 1 202567 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202567Orig1s000ltr.pdf
2013-07-19 00:00:00
32276 1 202570 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s003ltr.pdf
2012-02-29 00:00:00
32277 1 202570 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s006ltr.pdf
2013-11-25 00:00:00
32278 1 202570 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202570Orig1s011ltr.pdf
2014-06-02 00:00:00
32279 1 202570 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s014ltr.pdf
2015-09-16 00:00:00
32280 1 202577 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202577Orig1s000TA_ltr.
pdf 2015-03-10 00:00:00
32281 1 202580 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202580Orig1s000ltr.pdf
2013-12-05 00:00:00
32282 1 202583 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202583s000ltr.pdf
2011-12-05 00:00:00
32283 1 202598 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202598Orig1s000ltr.pdf
2012-11-07 00:00:00
32284 1 202603 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202603Orig1s000ltr.pdf
2015-06-11 00:00:00
32285 1 202611 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202611Orig1s000ltr.pdf
2012-06-28 00:00:00
32286 1 202611 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s005ltr.pdf
2015-11-04 00:00:00
32287 1 202687 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202687Orig1s000ltr.pdf
2014-06-10 00:00:00
32288 1 202714 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202714Orig1s000ltr.pdf
2012-07-20 00:00:00
32289 1 202714 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s008ltr.pdf
2015-04-03 00:00:00
32290 1 202714 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s009ltr.pdf
2015-07-27 00:00:00
32291 1 202714 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s010ltr.pdf
2016-01-22 00:00:00
32292 1 202723 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202723Orig1s000ltr.pdf
2013-07-26 00:00:00
32293 1 202727 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202727s000ltr.pdf
2012-05-22 00:00:00
32294 1 202731 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202731Orig1s000ltr.pdf
2013-12-06 00:00:00
32295 1 202736 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202736s000ltr.pdf
2012-02-10 00:00:00
32296 1 202738 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202738Orig1s000TAltr.p
df 2016-03-04 00:00:00
32297 1 202763 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s001ltr.pdf
2014-07-24 00:00:00
32298 1 202788 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s000ltr.pdf
2012-01-06 00:00:00
32299 1 202788 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf
2012-06-07 00:00:00
32300 1 202788 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788Orig1s002ltr.pdf
2012-09-04 00:00:00
32301 1 202788 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf
2012-06-07 00:00:00
32302 1 202788 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006lt
r.pdf 2013-08-05 00:00:00
32303 1 202788 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,0
12ltr.pdf 2014-12-31 00:00:00
32304 1 202795 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202795Orig1s000ltr.pdf
2013-01-25 00:00:00
32305 1 202799 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s000ltr.pdf
2012-03-27 00:00:00
32306 1 202802 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202802Orig1s000TAltr.p
df 2015-11-04 00:00:00
32307 1 202806 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s000ltr.pdf
2013-05-30 00:00:00
32308 1 202806 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202806Orig1s002ltr.pdf
2014-01-14 00:00:00
32309 1 202810 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202810Org1s000ltr.pdf
2012-10-23 00:00:00
32310 1 202810 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202810Orig1s005ltr.pdf
2015-12-08 00:00:00
32311 1 202811 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202811Orig1s000ltr.pdf
2012-08-31 00:00:00
32312 1 202811 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202811Orig1s003ltr.pdf
2013-08-12 00:00:00
32313 1 202811 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202811Orig1s004ltr.pdf
2014-07-10 00:00:00
32314 1 202811 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202811Orig1s009ltr.pdf
2015-11-24 00:00:00
32315 1 202813 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202813s000ltr.pdf
2012-03-27 00:00:00
32316 1 202813 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s005ltr.pdf
2014-03-20 00:00:00
32317 1 202813 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009lt
r.pdf 2014-12-18 00:00:00
32318 1 202814 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202814s000ltr.pdf
2012-06-18 00:00:00
32319 1 202832 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202832s000ltr.pdf
2012-01-10 00:00:00
32320 1 202833 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202833s000ltr.pdf
2012-01-30 00:00:00
32321 1 202833 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202833Orig1s002ltr.pdf
2014-03-14 00:00:00
32322 1 202834 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s003ltr.pdf
2014-02-26 00:00:00
32323 1 202834 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202834Orig1s005ltr.pdf
2015-06-24 00:00:00
32324 1 202834 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s006ltr.pdf
2014-11-17 00:00:00
32325 1 202840 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202840Orig1s000TAltr.p
df 2014-08-29 00:00:00
32326 1 202864 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202864Orig1s000ltr.pdf
2015-09-09 00:00:00
32327 1 202865 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202865Orig1s000ltr.pdf
2015-09-09 00:00:00
32328 1 202872 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202872Orig1s000ltr.pdf
2012-10-03 00:00:00
32329 1 202880 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202880Orig1s002ltr.pdf
2014-08-20 00:00:00
32330 1 202880 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s003ltr.pdf
2015-02-05 00:00:00
32331 1 202880 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s006ltr.pdf
2015-07-07 00:00:00
32332 1 202884 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202884Orig1s000ltr.pdf
2012-12-06 00:00:00
32333 1 202895 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895s001ltr.pdf
2012-02-29 00:00:00
32334 1 202895 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976
Orig1s027ltr.pdf 2013-04-25 00:00:00
32335 1 202895 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895
Orig1s005ltr.pdf 2013-02-04 00:00:00
32336 1 202895 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895
Orig1s007ltr.pdf 2013-02-26 00:00:00
32337 1 202895 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895
Orig1s011_replace_ltr.pdf 2014-04-08 00:00:00
32338 1 202895 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895
Orig1s013ltr.pdf 2015-05-28 00:00:00
32339 1 202912 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202912Orig1s000ltr.pdf
2013-12-09 00:00:00
32340 1 202941 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202941Orig1s000ltr.pdf
2014-01-03 00:00:00
32341 1 202956 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202956Orig1s000ltr.pdf
2015-10-02 00:00:00
32342 1 202964 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202964Orig1s000ltr.pdf
2016-05-04 00:00:00
32343 1 202969 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202969Orig1s000ltr.pdf
2014-09-02 00:00:00
32344 1 202971 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202971Orig1s006ltr.pdf
2015-07-30 00:00:00
32345 1 202984 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202984Orig1s000ltr.pdf
2013-10-01 00:00:00
32346 1 202990 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202990s000ltr.pdf
2012-06-28 00:00:00
32347 1 202992 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202992Orig1s001ltr.pdf
2014-10-22 00:00:00
32348 1 203030 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203030Orig1s000ltr.pdf
2015-10-21 00:00:00
32349 1 203032 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203032Orig1s000ltr.pdf
2015-05-26 00:00:00
32350 1 203036 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203036Orig1s000ltr.pdf
2016-01-22 00:00:00
32351 1 203039 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203039Orig1s000ltr.pdf
2015-11-30 00:00:00
32352 1 203045 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/203045s000ltr.pdf
2011-12-27 00:00:00
32353 1 203045 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001
ltr.pdf 2012-04-02 00:00:00
32354 1 203045 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002l
tr.pdf 2012-04-23 00:00:00
32355 1 203045 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045
Orig1s003ltr.pdf 2012-08-15 00:00:00
32356 1 203045 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045
Orig1s007ltr.pdf 2013-08-06 00:00:00
32357 1 203045 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045
Orig1s008ltr.pdf 2013-10-25 00:00:00
32358 1 203045 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145
Orig1s031,203045Orig1s009ltr.pdf 2013-12-31 00:00:00
32359 1 203045 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045
Orig1s010,205786Orig1s001ltr.pdf 2014-04-10 00:00:00
32360 1 203045 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045
Orig1s012,022145Orig1s035ltr.pdf 2015-02-24 00:00:00
32361 1 203049 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203049s000ltr.pdf
2012-01-09 00:00:00
32362 1 203049 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s005ltr.pdf
2016-05-27 00:00:00
32363 1 203050 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203050Orig1s000TAltr.p
df 2012-11-06 00:00:00
32364 1 203050 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203050Orig1s000ltr.pdf
2016-03-03 00:00:00
32365 1 203058 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203058Orig1s000ltr.pdf
2014-09-24 00:00:00
32366 1 203076 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203076Orig1s000ltr.pdf
2012-10-18 00:00:00
32367 1 203085 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203085Orig1s000ltr.pdf
2012-09-27 00:00:00
32368 1 203085 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203085Orig1s001ltr.pdf
2013-05-31 00:00:00
32369 1 203094 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig1s000ltr.pdf
2014-09-26 00:00:00
32370 1 203094 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203094Orig1s003ltr.pdf
2015-11-27 00:00:00
32371 1 203098 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203098Orig1s002ltr.pdf
2014-06-23 00:00:00
32372 1 203100 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/0203100Orig1s000ltr.pd
f 2012-08-29 00:00:00
32373 1 203100 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s009ltr.pdf
2013-10-25 00:00:00
32374 1 203100 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s010ltr.pdf
2014-09-02 00:00:00
32375 1 203100 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203100Orig1s016ltr.pdf
2015-07-30 00:00:00
32376 1 203100 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s021ltr.pdf
2016-02-23 00:00:00
32377 1 203108 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203108Orig1s000ltr.pdf
2014-08-01 00:00:00
32378 1 203109 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473
Orig1s004,203109Origs002ltr.pdf 2014-03-13 00:00:00
32379 1 203109 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;02
2473Orig1s005,006;203109Orig1s003,004ltr.pdf 2014-02-04 00:00:00
32380 1 203109 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473
Orig1s007,203109Orig1s005ltr.pdf 2014-03-07 00:00:00
32381 1 203136 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203136Orig1s000ltr.pdf
2013-02-26 00:00:00
32382 1 203137 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203137Orig1s000ltr.pdf
2013-10-29 00:00:00
32383 1 203146 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203146Orig1s000ltr.pdf
2014-09-23 00:00:00
32384 1 203159 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159Orig1s000ltr.pdf
2013-01-11 00:00:00
32385 1 203188 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188s000ltr.pdf
2012-01-31 00:00:00
32386 1 203188 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188Orig1s001ltr.pdf
2012-08-29 00:00:00
32387 1 203188 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s008ltr.pdf
2014-04-10 00:00:00
32388 1 203188 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015lt
r.pdf 2015-01-06 00:00:00
32389 1 203188 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203188Orig1s017ltr.pdf
2015-03-06 00:00:00
32390 1 203189 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203189Orig1s000ltr.pdf
2014-09-05 00:00:00
32391 1 203192 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203192Orig1s000ltr.pdf
2016-01-29 00:00:00
32392 1 203214 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203214Orig1s000ltr.pdf
2012-11-07 00:00:00
32393 1 203214 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s006ltr.pdf
2013-11-12 00:00:00
32394 1 203214 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s010ltr.pdf
2015-06-24 00:00:00
32395 1 203214 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203214Orig1s013ltr.pdf
2016-02-09 00:00:00
32396 1 203231 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203231Orig1s000TAltr.p
df 2012-11-13 00:00:00
32397 1 203231 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s002ltr.pdf
2014-05-06 00:00:00
32398 1 203231 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s
007ltr.pdf 2014-12-12 00:00:00
32399 1 203231 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s
007ltr.pdf 2014-12-12 00:00:00
32400 1 203231 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203231Orig1s010ltr.pdf
2015-10-13 00:00:00
32401 1 203232 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203232Orig1s000ltr.pdf
2014-08-07 00:00:00
32402 1 203260 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203260Orig1s000ltr.pdf
2014-01-03 00:00:00
32403 1 203263 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203263Orig1s000ltr.pdf
2013-02-05 00:00:00
32404 1 203283 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203283Orig1s000TAltr.p
df 2012-11-09 00:00:00
32405 1 203284 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203284Orig1s000ltr.pdf
2013-02-04 00:00:00
32406 1 203294 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203294Orig1s000ltr.pdf
2015-06-22 00:00:00
32407 1 203312 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf
2015-01-08 00:00:00
32408 3 203313 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203313and203314Orig1s000TOC.
cfm 2020-03-23 00:00:00
32410 1 203334 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203334Orig1s000ltr.pdf
2015-10-21 00:00:00
32411 1 203340 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203340Orig1s000ltr.pdf
2013-05-14 00:00:00
32412 1 203341 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203341Orig1s001ltr.pdf
2013-10-01 00:00:00
32413 1 203341 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203341Orig1s002ltr.pdf
2014-11-28 00:00:00
32414 1 203341 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s005ltr.pdf
2016-04-06 00:00:00
32415 1 203352 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203352Orig1s000ltr.pdf
2016-05-24 00:00:00
32416 1 203376 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203376Orig1s000ltr.pdf
2014-02-12 00:00:00
32417 1 203378 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203378Orig1s000ltr.pdf
2016-04-28 00:00:00
32418 1 203388 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s
007,s008ltr.pdf 2015-05-22 00:00:00
32419 1 203388 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s
007,s008ltr.pdf 2015-05-22 00:00:00
32420 1 203414 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203414Orig1s000ltr.pdf
2013-01-30 00:00:00
32421 1 203415 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203415Orig1s000ltr.pdf
2012-09-05 00:00:00
32422 1 203415 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s006ltr.pdf
2015-08-10 00:00:00
32423 1 203441 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203441Orig1s000ltr_rep
lacement.pdf 2012-12-27 00:00:00
32424 1 203441 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203441Orig1s002ltr.pdf
2014-06-27 00:00:00
32425 1 203443 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203443Orig1s000ltr.pdf
2019-05-21 00:00:00
32426 1 203469 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203469Orig1s000ltr.pdf
2012-12-19 00:00:00
32427 1 203469 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008lt
r.pdf 2013-12-20 00:00:00
32428 1 203469 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203469Orig1s009ltr.pdf
2014-07-28 00:00:00
32429 1 203469 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203469Orig1s020ltr.pdf
2015-12-03 00:00:00
32430 1 203469 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s021ltr.pdf
2016-06-06 00:00:00
32431 1 203479 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s000ltr.pdf
2013-02-08 00:00:00
32432 1 203479 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008lt
r.pdf 2015-09-17 00:00:00
32433 1 203496 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203496Orig1s000ltr.pdf
2013-12-24 00:00:00
32434 1 203505 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203505Orig1s005ltr.pdf
2015-02-27 00:00:00
32435 1 203510 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203510Orig1s000ltr.pdf
2013-03-22 00:00:00
32436 1 203511 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203511Orig1s000ltr.pdf
2014-11-10 00:00:00
32437 1 203518 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203518Orig1s000ltr.pdf
2015-05-19 00:00:00
32438 1 203551 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203551Orig1s001ltr.pdf
2013-11-07 00:00:00
32439 1 203551 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203551Orig1s002ltr.pdf
2014-09-23 00:00:00
32440 1 203563 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000TAltr.p
df 2015-03-11 00:00:00
32441 1 203564 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203564Orig1s000ltr.pdf
2014-11-05 00:00:00
32442 1 203567 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203567Orig1s000ltr.pdf
2014-06-10 00:00:00
32443 1 203567 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203567Orig1s002ltr.pdf
2015-03-02 00:00:00
32444 1 203568 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203568Orig1s002ltr.pdf
2014-05-09 00:00:00
32445 1 203573 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203573Orig1s000ltr.pdf
2014-12-23 00:00:00
32446 1 203583 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203583Orig1s000ltr.pdf
2015-10-02 00:00:00
32447 1 203585 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203585Orig1s000ltr.pdf
2012-10-29 00:00:00
32448 1 203585 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s001ltr.pdf
2014-02-12 00:00:00
32449 1 203585 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s003ltr.pdf
2014-05-06 00:00:00
32450 1 203585 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203585Orig1s004ltr.pdf
2016-06-15 00:00:00
32451 1 203586 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203586Orig1s000TAltr.p
df 2015-02-17 00:00:00
32452 1 203592 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203592Orig1s000ltr.pdf
2015-08-20 00:00:00
32453 1 203602 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203602Orig1s000ltr.pdf
2015-12-18 00:00:00
32454 1 203634 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203634Orig1s000ltr.pdf
2013-01-16 00:00:00
32455 1 203649 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203649Orig1s000ltr.pdf
2014-11-04 00:00:00
32456 1 203667 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s000ltr.pdf
2013-05-10 00:00:00
32457 1 203667 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203667Orig1s004ltr.pdf
2014-12-09 00:00:00
32458 1 203684 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203684Orig1s000ltr.pdf
2014-10-15 00:00:00
32459 1 203684 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203684Orig1s001ltr.pdf
2016-04-04 00:00:00
32460 1 203696 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943
Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf 2013-10-31 00:00:00
32461 1 203707 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203707Orig1s000ltr.pdf
2015-09-15 00:00:00
32462 1 203711 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203711Orig1s000ltr.pdf
2014-09-10 00:00:00
32463 1 203730 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203730Orig1s000ltr.pdf
2015-06-03 00:00:00
32464 1 203741 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203741Orig1s000ltr.pdf
2015-06-26 00:00:00
32465 1 203756 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203756Orig1s002ltr.pdf
2016-05-24 00:00:00
32466 1 203791 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203791Orig1s000ltr.pdf
2013-04-16 00:00:00
32467 1 203794 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203794Orig1s000ltr.pdf
2012-10-18 00:00:00
32468 1 203794 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003lt
r.pdf 2014-11-19 00:00:00
32469 1 203797 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203797Orig1s000ltr.pdf
2013-03-19 00:00:00
32470 1 203797 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203797Orig1s000TAltr.p
df 2015-02-19 00:00:00
32471 1 203823 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203823Orig1s000ltr.pdf
2014-08-04 00:00:00
32472 1 203835 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203835Orig1s000ltr.pdf
2015-08-14 00:00:00
32473 1 203858 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203858Orig1s000ltr_rep
lace.pdf 2012-12-27 00:00:00
32474 1 203858 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s002ltr.pdf
2013-04-16 00:00:00
32475 1 203858 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s012ltr.pdf
2016-03-10 00:00:00
32476 1 203858 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s015ltr.pdf
2016-05-25 00:00:00
32477 1 203873 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203873Orig1s000ltr.pdf
2016-05-17 00:00:00
32478 1 203922 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203922s000ltr.pdf
2012-02-21 00:00:00
32479 1 203923 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203923s000ltr.pdf
2012-02-21 00:00:00
32480 1 203924 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203924Orig1s000ltr.pdf
2014-02-10 00:00:00
32481 1 203950 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203950Orig1s000ltr.pdf
2015-12-16 00:00:00
32482 1 203955 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203955Orig1s000ltr.pdf
2016-04-13 00:00:00
32483 1 203971 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203971Orig1s000ltr.pdf
2013-05-16 00:00:00
32484 1 203975 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203975Orig1s000ltr.pdf
2013-12-20 00:00:00
32485 1 203985 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,02
4,203985Orig1s002,004,005_replace_ltr.pdf 2014-02-21 00:00:00
32486 1 203985 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985
Orig1s003ltr.pdf 2013-11-07 00:00:00
32487 1 203985 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,02
4,203985Orig1s002,004,005_replace_ltr.pdf 2014-02-21 00:00:00
32488 1 203993 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202067Orig1s003,203993
Orig1s003ltr.pdf 2014-12-11 00:00:00
32489 1 204003 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204003Orig1s000ltr.pdf
2015-07-08 00:00:00
32490 1 204016 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204016Orig1s000ltr.pdf
2013-07-08 00:00:00
32491 1 204026 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s004ltr.pdf
2014-09-16 00:00:00
32492 1 204028 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204028Orig1s000ltr.pdf
2015-07-08 00:00:00
32493 1 204042 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204042Orig1s000ltr.pdf
2013-04-01 00:00:00
32494 1 204042 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s011ltr.pdf
2016-03-30 00:00:00
32495 1 204042 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s013ltr.pdf
2015-12-08 00:00:00
32496 1 204042 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019lt
r.pdf 2016-05-24 00:00:00
32497 1 204061 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204061Orig1s000ltr.pdf
2013-03-29 00:00:00
32498 1 204063 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s
010ltr.pdf 2014-12-04 00:00:00
32499 1 204063 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s
010ltr.pdf 2014-12-04 00:00:00
32500 1 204063 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s
010ltr.pdf 2014-12-04 00:00:00
32501 1 204063 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204063Orig1s014ltr.pdf
2016-03-02 00:00:00
32502 1 204078 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204078Orig1s000ltr.pdf
2013-06-04 00:00:00
32503 1 204078 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204078Orig1s007ltr.pdf
2015-10-21 00:00:00
32504 1 204079 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204079Orig1s000ltr.pdf
2015-06-02 00:00:00
32505 1 204082 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204082Orig1s000ltr.pdf
2016-02-18 00:00:00
32506 1 204083 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204083Orig1s000ltr.pdf
2016-02-18 00:00:00
32507 1 204085 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204085Orig1s000ltr.pdf
2014-09-16 00:00:00
32509 1 204096 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204096Orig1s000ltr.pdf
2013-07-26 00:00:00
32510 1 204096 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr
.pdf 2015-12-18 00:00:00
32511 1 204114 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204114Orig1s000ltr.pdf
2013-05-30 00:00:00
32512 1 204114 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204114Orig1s001ltr.pdf
2014-01-10 00:00:00
32513 1 204114 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204114Orig1s004ltr.pdf
2015-11-23 00:00:00
32514 1 204132 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204132Orig1s000ltr.pdf
2015-08-25 00:00:00
32515 1 204141 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204141Orig1s000ltr.pdf
2013-04-16 00:00:00
32516 1 204141 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204141Orig1s004ltr.pdf
2015-12-17 00:00:00
32517 1 204150 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.p
df 2013-01-11 00:00:00
32518 1 204150 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204150Orig1s000ltr.pdf
2013-03-05 00:00:00
32519 1 204150 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002lt
r.pdf 2014-07-09 00:00:00
32520 1 204150 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204150Orig1s003ltr.pdf
2015-05-19 00:00:00
32521 1 204153 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204153Orig1s000ltr.pdf
2013-11-15 00:00:00
32522 1 204154 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204154Orig1s000ltr.pdf
2014-10-28 00:00:00
32523 1 204168 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s001ltr.pdf
2014-05-27 00:00:00
32524 1 204200 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204200Orig1s000ltr.pdf
2012-12-27 00:00:00
32525 1 204239 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204239Orig1s000TAltr.p
df 2015-04-13 00:00:00
32526 1 204242 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s002ltr.pdf
2013-09-09 00:00:00
32527 1 204242 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s004ltr.pdf
2015-08-11 00:00:00
32528 1 204242 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s005ltr.pdf
2015-02-17 00:00:00
32529 1 204242 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s006ltr.pdf
2015-06-10 00:00:00
32530 1 204242 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s008ltr.pdf
2016-07-12 00:00:00
32531 1 204251 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204251Orig1s000ltr.pdf
2013-04-24 00:00:00
32532 1 204251 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204251Orig1s006ltr.pdf
2015-11-09 00:00:00
32533 1 204275 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204275Orig1s000ltr.pdf
2013-05-13 00:00:00
32534 1 204275 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s001ltr.pdf
2015-05-04 00:00:00
32535 1 204275 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s004ltr.pdf
2015-09-16 00:00:00
32536 1 204275 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s009ltr.pdf
2016-02-18 00:00:00
32537 1 204286 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204286Orig1s000ltr.pdf
2013-07-01 00:00:00
32538 1 204286 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s001ltr.pdf
2014-10-14 00:00:00
32539 1 204286 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s002ltr.pdf
2014-09-25 00:00:00
32540 1 204300 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204300Orig1s000ltr.pdf
2014-06-30 00:00:00
32541 1 204300 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204300Orig1s005ltr.pdf
2015-05-29 00:00:00
32542 1 204308 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003lt
r.pdf 2014-09-08 00:00:00
32543 1 204353 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s003ltr.pdf
2015-09-14 00:00:00
32544 1 204353 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015lt
r.pdf 2016-05-24 00:00:00
32545 1 204372 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204372Orig1s000ltr.pdf
2015-07-24 00:00:00
32546 1 204384 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204384Orig1s000ltr.pdf
2013-01-02 00:00:00
32547 1 204384 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204384Orig1s002ltr.pdf
2013-08-29 00:00:00
32548 1 204384 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s005ltr.pdf
2015-05-19 00:00:00
32549 1 204403 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204403Orig1s000ltr.pdf
2015-09-08 00:00:00
32550 1 204403 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204403Orig1s000TAltr.p
df 2015-07-23 00:00:00
32551 1 204410 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204410Orig1s000ltr.pdf
2013-10-22 00:00:00
32552 1 204410 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s002ltr.pdf
2015-11-19 00:00:00
32553 1 204410 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s003ltr.pdf
2015-05-04 00:00:00
32554 1 204410 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s006ltr.pdf
2016-02-19 00:00:00
32555 1 204410 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s008ltr.pdf
2016-06-21 00:00:00
32556 1 204412 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204412Orig1s000ltr.pdf
2013-02-05 00:00:00
32557 1 204412 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s003ltr.pdf
2014-04-29 00:00:00
32558 1 204426 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204426Orig1s000ltr.pdf
2013-04-24 00:00:00
32559 1 204427 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204427Orig1s000ltr.pdf
2014-07-09 00:00:00
32560 1 204431 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204431Orig1s000ltr.pdf
2015-10-21 00:00:00
32561 1 204442 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204442Orig1s000ltr.pdf
2016-05-26 00:00:00
32562 1 204446 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204446Orig1s000ltr.pdf
2015-06-02 00:00:00
32563 1 204447 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf
2013-10-02 00:00:00
32564 1 204505 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204505Orig1s000ltr.pdf
2013-10-22 00:00:00
32565 1 204508 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204508Orig1s000ltr.pdf
2013-10-04 00:00:00
32566 1 204516 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204516Orig1s000ltr.pdf
2013-07-02 00:00:00
32567 1 204516 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204516Orig1s003ltr.pdf
2014-12-02 00:00:00
32568 1 204569 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.pd
f 2014-08-14 00:00:00
32569 1 204582 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204582Orig1s000ltr.pdf
2015-09-24 00:00:00
32570 1 204592 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004lt
r.pdf 2014-08-27 00:00:00
32571 1 204605 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204605Orig1s000ltr.pdf
2014-06-23 00:00:00
32572 1 204629 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204629Orig1s000ltr.pdf
2014-08-04 00:00:00
32573 1 204629 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s
003ltr.pdf 2015-06-30 00:00:00
32574 1 204629 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s
003ltr.pdf 2015-06-30 00:00:00
32575 1 204629 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s004ltr.pdf
2016-02-09 00:00:00
32576 1 204629 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s007ltr.pdf
2015-12-08 00:00:00
32577 1 204654 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204654Orig1s000ltr.pdf
2013-07-26 00:00:00
32578 1 204671 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204671Orig1s001ltr.pdf
2014-11-18 00:00:00
32579 1 204677 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s000ltr.pdf
2014-03-21 00:00:00
32580 1 204677 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s001ltr.pdf
2014-04-04 00:00:00
32581 1 204683 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s000ltr.pdf
2013-07-12 00:00:00
32582 1 204683 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s001ltr.pdf
2013-10-01 00:00:00
32583 1 204683 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204683Orig1s002ltr.pdf
2014-07-17 00:00:00
32585 1 204736 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736
Orig1s003ltr.pdf 2016-04-06 00:00:00
32586 1 204736 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973
Orig1s034ltr.pdf 2014-10-21 00:00:00
32587 1 204736 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736
Orig1s005ltr.pdf 2014-12-24 00:00:00
32589 1 204781 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204781Orig1s000ltr.pdf
2013-03-22 00:00:00
32590 1 204790 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s001ltr.pdf
2014-05-13 00:00:00
32591 1 204790 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s002ltr.pdf
2014-12-24 00:00:00
32592 1 204790 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s007ltr.pdf
2016-04-26 00:00:00
32593 1 204790 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s008ltr.pdf
2016-06-10 00:00:00
32594 1 204802 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204802Orig1s000ltr.pdf
2015-11-09 00:00:00
32595 1 204819 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204819Orig1s000ltr.pdf
2013-10-10 00:00:00
32596 1 204820 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204820Orig1s000ltr.pdf
2014-09-30 00:00:00
32597 1 204824 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824
Orig2s000_replace_ltr.pdf 2013-10-16 00:00:00
32598 1 204833 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204833Orig1s000ltr.pdf
2016-02-29 00:00:00
32599 1 204835 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204835Orig1s000ltr.pdf
2015-04-24 00:00:00
32603 1 204886 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204886Orig1s002ltr.pdf
2015-04-17 00:00:00
32604 1 204900 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204900Orig1s000ltr.pdf
2015-07-28 00:00:00
32607 1 204977 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204977s000lbl.pdf
2014-04-25 00:00:00
32608 1 204988 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204988Orig1s000ltr.pdf
2016-05-18 00:00:00
32609 1 205001 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205001Orig1s000ltr.pdf
2016-07-07 00:00:00
32610 1 205003 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s000ltr.pdf
2015-01-23 00:00:00
32612 1 205006 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205006Orig1s000TAltr.p
df 2015-10-30 00:00:00
32613 1 205015 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205015Orig1s000TAltr.p
df 2016-05-04 00:00:00
32616 1 205029 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205029Orig1s000ltr.pdf
2014-07-31 00:00:00
32617 1 205029 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205029Orig1s001ltr.pdf
2015-10-26 00:00:00
32618 1 205029 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s002ltr.pdf
2016-02-12 00:00:00
32619 1 205053 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205053Orig1s000ltr.pdf
2013-11-27 00:00:00
32620 1 205053 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205053Orig1s001ltr.pdf
2014-06-12 00:00:00
32621 1 205053 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,2
05053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 2015-11-18 00:00:00
32622 1 205053 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,2
05053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 2015-11-18 00:00:00
32623 1 205055 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205055Orig1s000ltr.pdf
2015-12-16 00:00:00
32624 1 205060 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205060Orig1s000ltr.pdf
2014-05-06 00:00:00
32625 1 205065 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205065Orig1s000ltr.pdf
2013-12-20 00:00:00
32626 1 205075 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205075Orig1s000ltr.pdf
2016-05-18 00:00:00
32627 1 205076 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205076Orig1s000ltr.pdf
2016-03-09 00:00:00
32628 1 205095 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205095Orig1s000ltr.pdf
2016-05-18 00:00:00
32629 1 205098 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205098Orig1s018ltr.pdf
2016-06-24 00:00:00
32630 1 205101 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205101Orig1s000ltr.pdf
2016-02-11 00:00:00
32631 1 205108 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205108Orig1s000Approv.pdf
2014-12-18 00:00:00
32632 1 205109 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205109Orig1s001ltr.pdf
2014-09-26 00:00:00
32633 1 205120 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205120Orig1s000ltr.pdf
2015-11-03 00:00:00
32634 1 205122 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205122Orig1s000ltr.pdf
2014-03-13 00:00:00
32635 1 205123 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s000ltr.pdf
2013-11-25 00:00:00
32636 1 205123 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s001ltr.pdf
2013-12-09 00:00:00
32637 1 205123 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s002ltr.pdf
2014-11-07 00:00:00
32638 1 205123 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s003ltr.pdf
2014-09-08 00:00:00
32639 1 205123 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s005ltr.pdf
2015-10-06 00:00:00
32640 1 205123 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s006ltr.pdf
2015-10-06 00:00:00
32641 1 205123 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s008ltr.pdf
2015-04-17 00:00:00
32642 1 205123 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s009ltr.pdf
2015-04-13 00:00:00
32643 1 205123 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s011ltr.pdf
2016-05-24 00:00:00
32644 1 205177 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205177Orig1s000ltr.pdf
2016-04-04 00:00:00
32645 1 205208 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205208Orig1s000ltr.pdf
2013-10-16 00:00:00
32646 1 205208 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205208Orig1s001ltr.pdf
2014-07-25 00:00:00
32647 1 205239 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205239Orig1s000ltr.pdf
2016-02-22 00:00:00
32648 1 205248 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205248Orig1s000ltr.pdf
2016-07-11 00:00:00
32649 1 205258 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205258Orig1s000ltr.pdf
2014-04-04 00:00:00
32650 1 205266 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205266Orig1s000ltr.pdf
2015-07-24 00:00:00
32651 1 205302 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205302Orig1s000TALtr_c
orrected.pdf 2015-09-30 00:00:00
32652 1 205332 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205332Orig1s000ltr.pdf
2015-08-21 00:00:00
32653 1 205342 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205342Orig1s000ltr.pdf
2016-04-15 00:00:00
32654 1 205352 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s001ltr.pdf
2014-09-03 00:00:00
32655 1 205352 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s002ltr.pdf
2014-11-24 00:00:00
32656 1 205352 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s003ltr.pdf
2015-02-27 00:00:00
32657 1 205352 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s005ltr.pdf
2015-08-18 00:00:00
32658 1 205352 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s006ltr.pdf
2015-10-30 00:00:00
32659 1 205352 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s007ltr.pdf
2015-12-30 00:00:00
32660 1 205353 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205353Orig1s000ltr.pdf
2015-02-24 00:00:00
32661 1 205353 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205353Orig1s001ltr.pdf
2016-06-08 00:00:00
32662 1 205355 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205355Orig1s000ltr.pdf
2014-03-19 00:00:00
32663 1 205379 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205379Orig1s000ltr.pdf
2015-10-02 00:00:00
32664 1 205382 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205382Orig1s002ltr.pdf
2016-02-26 00:00:00
32666 1 205388 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205388Orig1s000ltr.pdf
2014-06-03 00:00:00
32668 1 205412 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205412Orig1s000TAltr.p
df 2014-09-29 00:00:00
32669 1 205415 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205415Orig1s000ltr.pdf
2016-01-15 00:00:00
32670 1 205421 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205421Orig1s000TAltr.p
df 2016-07-05 00:00:00
32671 1 205433 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.pdf
2014-12-03 00:00:00
32672 1 205433 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.p
df 2014-08-27 00:00:00
32673 1 205434 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s001ltr.pdf
2015-10-02 00:00:00
32674 1 205434 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s003ltr.pdf
2015-11-27 00:00:00
32675 1 205435 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205435Orig1s000ltr.pdf
2014-06-23 00:00:00
32676 1 205435 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436
Orig1s001ltr.pdf 2015-03-06 00:00:00
32677 1 205437 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205437Orig1s000ltr.pdf
2014-03-25 00:00:00
32678 1 205437 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205437Orig1s005ltr.pdf
2015-12-22 00:00:00
32679 1 205474 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205474Orig1s000ltr.pdf
2014-11-18 00:00:00
32680 1 205488 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205488Orig1s001ltr.pdf
2015-05-13 00:00:00
32681 1 205508 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205508Orig1s000TAltr.p
df 2014-03-19 00:00:00
32682 1 205517 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205517Orig1s000TAltr.p
df 2015-09-01 00:00:00
32684 1 205551 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205551Orig1s000ltr.pdf
2014-08-27 00:00:00
32685 1 205552 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205552Orig1s002ltr.pdf
2015-01-29 00:00:00
32686 1 205552 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s007ltr.pdf
2016-03-08 00:00:00
32687 1 205552 SUPPL 12 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s012ltr.pdf
2016-06-29 00:00:00
32688 1 205572 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205572Orig1s002ltr.pdf
2016-07-26 00:00:00
32689 1 205574 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205574Orig1s000TAltr.p
df 2015-12-08 00:00:00
32690 1 205574 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205574Orig1s000ltr.pdf
2016-05-20 00:00:00
32691 1 205583 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003lt
r.pdf 2014-07-23 00:00:00
32692 1 205583 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003lt
r.pdf 2014-07-23 00:00:00
32693 1 205596 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,2
05053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 2015-11-18 00:00:00
32694 1 205613 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000TAltr.p
df 2014-09-17 00:00:00
32695 1 205636 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000ltr.pdf
2015-04-03 00:00:00
32696 1 205636 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000TAltr.p
df 2015-03-10 00:00:00
32697 1 205637 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s009ltr.pdf
2016-07-11 00:00:00
32698 1 205641 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205641Orig1s002ltr.pdf
2015-06-18 00:00:00
32699 1 205645 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205645Orig1s000ltr.pdf
2016-12-06 00:00:00
32700 1 205649 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205649Orig1s003ltr.pdf
2015-12-07 00:00:00
32701 1 205649 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s004ltr.pdf
2016-06-16 00:00:00
32702 3 205692 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm
2020-03-23 00:00:00
32703 14 205692 ORIG 1 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
32704 14 205692 SUPPL 5 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
32705 1 205703 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205703Orig1s000ltr.pdf
2014-04-16 00:00:00
32706 1 205703 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205703Orig1s000ltr.pdf
2016-04-11 00:00:00
32707 1 205704 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205704MGLtr.pdf
2015-09-30 00:00:00
32708 1 205712 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205712MGLtr.pdf
2015-09-30 00:00:00
32709 1 205718 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205718Orig1s000ltr.pdf
2014-10-10 00:00:00
32710 1 205718 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205718Orig1s003ltr.pdf
2015-04-29 00:00:00
32711 1 205738 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205738MGLtr.pdf
2015-10-02 00:00:00
32712 1 205739 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205739Orig1s000ltr.pdf
2015-10-23 00:00:00
32713 1 205739 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s001ltr.pdf
2016-05-24 00:00:00
32714 1 205750 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205750Orig1s000ltr.pdf
2015-03-18 00:00:00
32715 1 205755 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205755Orig1s000ltr.pdf
2014-04-30 00:00:00
32716 1 205755 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004lt
r.pdf 2015-07-23 00:00:00
32717 1 205758 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205758Orig1s000ltr.pdf
2015-05-27 00:00:00
32718 1 205765 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205765MGltr.pdf
2015-10-06 00:00:00
32719 1 205767 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205767MGLtr.pdf
2015-10-02 00:00:00
32720 1 205772 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205772Orig1s000ltr.pdf
2015-06-11 00:00:00
32721 1 205777 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s000ltr.pdf
2014-07-23 00:00:00
32722 1 205777 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s001ltr.pdf
2014-08-20 00:00:00
32723 1 205777 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s003ltr.pdf
2016-04-22 00:00:00
32724 1 205786 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045
Orig1s010,205786Orig1s001ltr.pdf 2014-04-10 00:00:00
32725 1 205786 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045
Orig1s011,022145Orig1s034ltr.pdf 2015-02-19 00:00:00
32726 1 205786 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045
Orig1s012,022145Orig1s035ltr.pdf 2015-02-24 00:00:00
32727 1 205787 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205787Orig1s000ltr.pdf
2014-04-03 00:00:00
32728 1 205796 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205796MGLtr.pdf
2015-10-13 00:00:00
32729 1 205803 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205803MGLtr.pdf
2015-10-02 00:00:00
32730 1 205809 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205809MGLtr.pdf
2015-10-01 00:00:00
32731 1 205815 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205815MGLtr.pdf
2015-10-01 00:00:00
32732 1 205816 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205816MGLtr.pdf
2015-10-02 00:00:00
32733 1 205817 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205817MGLtr.pdf
2015-10-01 00:00:00
32734 1 205818 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205818MGLtr.pdf
2015-10-01 00:00:00
32735 1 205819 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205819MGltr.pdf
2015-10-06 00:00:00
32736 1 205820 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205820MGLtr.pdf
2015-10-01 00:00:00
32737 1 205821 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205821MGLtr.pdf
2015-10-02 00:00:00
32738 1 205827 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205827MGLtr.pdf
2015-10-02 00:00:00
32739 1 205831 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205831Orig1s000ltr.pdf
2015-04-27 00:00:00
32740 1 205834 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s001ltr.pdf
2015-03-24 00:00:00
32741 1 205834 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s002ltr.pdf
2015-11-16 00:00:00
32742 1 205834 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005lt
r.pdf 2015-11-16 00:00:00
32743 1 205834 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s
009ltr.pdf 2016-02-16 00:00:00
32744 1 205834 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s010ltr.pdf
2016-06-09 00:00:00
32745 1 205834 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s011ltr.pdf
2016-03-31 00:00:00
32746 1 205836 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/0205836Orig1s000,02058
37Orig1s000,0205838Orig1s000ltr.pdf 2016-02-19 00:00:00
32747 1 205836 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205836Orig1s001,205837
Orig1s001,205838Orig1s001ltr.pdf 2016-06-06 00:00:00
32748 1 205837 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205836Orig1s001,205837
Orig1s001,205838Orig1s001ltr.pdf 2016-06-06 00:00:00
32749 1 205838 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205836Orig1s001,205837
Orig1s001,205838Orig1s001ltr.pdf 2016-06-06 00:00:00
32750 1 205840 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205840MGLtr.pdf
2015-10-02 00:00:00
32751 1 205845 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205845MGLtr.pdf
2015-10-01 00:00:00
32752 1 205846 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205846MGLtr.pdf
2015-09-30 00:00:00
32753 1 205847 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205847MGLtr.pdf
2015-10-02 00:00:00
32754 1 205850 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205850MGLtr.pdf
2015-09-30 00:00:00
32755 1 205851 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205851MGLtr.pdf
2015-09-30 00:00:00
32756 1 205859 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205859MGLtr.pdf
2015-09-30 00:00:00
32757 1 205862 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205862MGLtr.pdf
2015-09-29 00:00:00
32758 1 205864 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205864MGLtr.pdf
2015-09-29 00:00:00
32759 1 205865 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205865MGLtr.pdf
2015-09-29 00:00:00
32760 1 205874 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s001ltr.pdf
2014-11-17 00:00:00
32761 1 205874 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205874Orig1s004ltr.pdf
2015-07-23 00:00:00
32762 1 205883 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205883Orig1s000ltr.pdf
2016-04-14 00:00:00
32763 1 205890 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205890MGLtr.pdf
2015-10-01 00:00:00
32764 1 205891 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205891MGLtr.pdf
2015-09-29 00:00:00
32765 1 205912 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205912MGLtr.pdf
2015-09-29 00:00:00
32766 1 205917 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205917Orig1s000ltr.pdf
2014-11-19 00:00:00
32767 1 205931 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205931Orig1s000ltr.pdf
2014-07-28 00:00:00
32768 1 205931 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205931Orig1s002ltr.pdf
2016-04-28 00:00:00
32769 1 205942 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205942Orig1s000TAltr.p
df 2016-01-22 00:00:00
32770 1 205962 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205962TAltr.pdf
2015-12-31 00:00:00
32771 1 205972 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205972Orig1s000TAltr.p
df 2016-01-29 00:00:00
32772 1 205992 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205992MGLtr.pdf
2015-09-30 00:00:00
32773 1 205999 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205999MGLtr.pdf
2015-09-30 00:00:00
32774 1 206025 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/206025MGLtr.pdf
2015-09-30 00:00:00
32775 1 206041 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206041Orig1s000TAltr.p
df 2014-09-08 00:00:00
32776 1 206073 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s000ltr.pdf
2015-02-03 00:00:00
32777 1 206073 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281
s010,206073Orig1s001ltr.pdf 2015-09-01 00:00:00
32778 1 206088 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206088Orig1s000ltr.pdf
2014-09-24 00:00:00
32779 1 206111 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s000ltr.pdf
2015-09-02 00:00:00
32780 1 206111 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s
009ltr.pdf 2016-07-12 00:00:00
32781 1 206111 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s002ltr.pdf
2015-12-07 00:00:00
32782 1 206128 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206128Orig1s000ltr.pdf
2016-06-01 00:00:00
32783 1 206162 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206162Orig1s000ltr.pdf
2014-12-19 00:00:00
32784 1 206163 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206163Orig1s000ltr.pdf
2016-07-01 00:00:00
32785 1 206192 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206192Orig1s001ltr.pdf
2016-06-01 00:00:00
32786 1 206197 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206197Orig1s000ltr.pdf
2016-06-10 00:00:00
32787 1 206256 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206256Orig1s000ltr.pdf
2014-07-03 00:00:00
32788 1 206271 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206271Orig1s000ltr.pdf
2015-11-13 00:00:00
32789 1 206286 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206286Orig1s000TAltr.p
df 2015-10-20 00:00:00
32790 1 206287 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206287Orig1s000ltr.pdf
2016-05-26 00:00:00
32791 1 206289 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206289Orig1s000ltr.pdf
2014-07-23 00:00:00
32792 1 206298 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206298Orig1s000ltr.pdf
2016-05-04 00:00:00
32793 1 206302 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206302Orig1s000ltr.pdf
2016-06-06 00:00:00
32794 1 206306 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206306Orig1s000ltr.pdf
2015-12-09 00:00:00
32795 1 206316 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s000ltr.pdf
2015-01-09 00:00:00
32796 1 206321 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206321Orig1s001ltr.pdf
2015-03-31 00:00:00
32797 1 206321 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s002ltr.pdf
2016-02-02 00:00:00
32798 1 206333 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206333Orig1s000ltr.pdf
2015-04-29 00:00:00
32799 1 206334 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206334Orig1s000ltr.pdf
2014-08-07 00:00:00
32800 1 206336 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206336Orig1s000ltr.pdf
2015-09-10 00:00:00
32801 1 206352 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206352Orig1s003,021567
Orig1s038ltr.pdf 2015-09-28 00:00:00
32802 1 206367 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206367Orig1s000ltr.pdf
2015-12-16 00:00:00
32803 1 206369 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206369Orig1s000ltr.pdf
2015-09-04 00:00:00
32804 1 206406 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206406Orig1s000TAltr.p
df 2014-11-04 00:00:00
32805 1 206406 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206406Orig1s001ltr.pdf
2015-08-13 00:00:00
32806 1 206406 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206406Orig1s003ltr.pdf
2016-06-24 00:00:00
32807 1 206422 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206422Orig1s000ltr.pdf
2015-09-04 00:00:00
32808 1 206426 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206426Orig1s000ltr.pdf
2014-12-23 00:00:00
32809 1 206456 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206456Orig1s000ltr.pdf
2015-06-18 00:00:00
32810 1 206494 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494Orig1s000ltr.pdf
2015-02-27 00:00:00
32811 1 206494 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494orig1s001ltr.pdf
2015-09-04 00:00:00
32812 1 206494 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206494Orig1s002ltr.pdf
2016-06-23 00:00:00
32813 1 206511 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206511Orig1s000ltr.pdf
2015-09-08 00:00:00
32814 1 206530 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206530Orig1s000ltr.pdf
2015-12-30 00:00:00
32815 1 206545 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206545Orig1s000ltr.pdf
2014-07-23 00:00:00
32816 1 206581 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206581Orig1s000ltr.pdf
2015-08-06 00:00:00
32817 1 206619 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206619Orig1s000ltr.pdf
2014-12-23 00:00:00
32818 1 206619 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s003ltr.pdf
2015-03-26 00:00:00
32819 1 206619 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s006ltr.pdf
2015-10-14 00:00:00
32820 1 206627 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206627Orig1s000ltr.pdf
2014-11-20 00:00:00
32821 1 206627 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206627Orig1s001ltr.pdf
2015-07-08 00:00:00
32822 1 206627 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s003ltr.pdf
2016-04-22 00:00:00
32823 1 206756 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s000ltr.pdf
2015-05-21 00:00:00
32824 1 206756 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s002ltr.pdf
2016-03-22 00:00:00
32826 1 206769 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206769Orig1s000ltr.pdf
2014-12-17 00:00:00
32827 1 206769 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206769Orig1s002ltr.pdf
2016-05-27 00:00:00
32828 1 206792 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206792Orig1s000ltr.pdf
2016-05-16 00:00:00
32829 1 206814 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206814Orig1s000ltr.pdf
2014-12-30 00:00:00
32830 1 206843 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s002ltr.pdf
2016-02-09 00:00:00
32831 1 206845 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206845Orig1s000ltr.pdf
2016-03-14 00:00:00
32832 1 206910 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003lt
r.pdf 2015-10-26 00:00:00
32833 1 206910 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003lt
r.pdf 2015-10-26 00:00:00
32834 1 206911 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206911Orig1s000ltr.pdf
2016-04-12 00:00:00
32835 1 206940 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206940Orig1s000ltr.pdf
2015-05-28 00:00:00
32836 1 206940 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206940Orig1s001ltr.pdf
2016-02-12 00:00:00
32837 1 206947 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206947Orig1s000ltr.pdf
2015-02-17 00:00:00
32838 1 206947 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s003ltr.pdf
2016-05-16 00:00:00
32839 1 207026 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021703Orig1s017,207026
Orig1s002ltr.pdf 2016-07-22 00:00:00
32840 1 207027 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207027Orig1s000ltr.pdf
2015-08-25 00:00:00
32841 1 207036 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/207036MGLtr.pdf
2015-10-01 00:00:00
32842 1 207070 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207070Orig1s000ltr.pdf
2015-09-17 00:00:00
32843 1 207071 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207071Orig1s000ltr.pdf
2015-07-31 00:00:00
32844 1 207096 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207096Orig1s000ltr.pdf
2016-02-26 00:00:00
32845 1 207103 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207103Orig1s000ltr.pdf
2015-02-04 00:00:00
32846 1 207114 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/207114MGLtr.pdf
2015-10-01 00:00:00
32847 1 207131 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207131Orig1s000ltr.pdf
2015-08-24 00:00:00
32848 1 207154 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207154Orig1s000ltr.pdf
2016-02-26 00:00:00
32849 1 207155 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207155Orig1s000,Orig2s
000ltr.pdf 2016-03-14 00:00:00
32850 1 207174 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207174Orig1s000ltr.pdf
2016-02-09 00:00:00
32851 1 207233 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207233Orig1s000ltr.pdf
2015-10-28 00:00:00
32852 1 207358 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207358Orig1s000ltr.pdf
2016-03-02 00:00:00
32853 1 207500 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s000ltr.pdf
2015-03-06 00:00:00
32854 1 207500 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501
Orig1s001ltr.pdf 2015-04-06 00:00:00
32855 1 207561 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207561Orig1s000ltr.pdf
2015-11-09 00:00:00
32856 1 207561 SUPPL 3 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s003ltr.pdf
2016-03-10 00:00:00
32857 1 207589 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207589Orig1s001ltr.pdf
2016-03-10 00:00:00
32858 1 207620 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207620Orig1s000ltr.pdf
2015-07-07 00:00:00
32859 1 207631 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207631Orig1s000ltr.pdf
2016-07-19 00:00:00
32860 1 207768 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207768Orig1s000ltr.pdf
2015-05-05 00:00:00
32861 1 207793 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207793Orig1s000ltr.pdf
2015-10-26 00:00:00
32864 1 207923 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207923Orig1s000ltr.pdf
2015-11-03 00:00:00
32865 1 207931 SUPPL 2 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s002ltr.pdf
2016-01-29 00:00:00
32866 1 207947 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207947Orig1s000ltr.pdf
2015-12-22 00:00:00
32867 1 207949 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207949Orig1s000ltr.pdf
2015-06-26 00:00:00
32868 1 207953 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207953Orig1s000ltr.pdf
2015-10-23 00:00:00
32869 1 207953 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207953Orig1s001ltr.pdf
2016-07-22 00:00:00
32870 1 207958 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207958Orig1s000ltr.pdf
2015-08-04 00:00:00
32871 1 207960 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207960Orig1s000ltr.pdf
2015-12-08 00:00:00
32872 1 207970 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207970Orig1s000TAltr.p
df 2015-08-21 00:00:00
32873 1 207986 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207986Orig1s001ltr.pdf
2016-01-28 00:00:00
32874 1 207988 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207988Orig1s000ltr.pdf
2015-12-23 00:00:00
32875 1 207999 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207999Orig1s000ltr.pdf
2016-05-31 00:00:00
32876 1 208010 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208010Orig1s000ltr.pdf
2016-06-21 00:00:00
32877 1 208025 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208025Orig1s000ltr.pdf
2016-06-13 00:00:00
32878 1 208026 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208026Orig1s000ltr.pdf
2016-06-01 00:00:00
32879 1 208030 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208030Orig1s000ltr.pdf
2015-09-10 00:00:00
32880 1 208032 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208032Orig1s000ltr.pdf
2016-07-11 00:00:00
32881 1 208036 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208036Orig1s000Approvedt.pdf
2016-01-12 00:00:00
32882 1 208054 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208054Orig1s000ltr.pdf
2016-05-27 00:00:00
32883 1 208056 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208056Orig1s000ltr.pdf
2016-02-03 00:00:00
32884 1 208056 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s
023,208056Orig1s001ltr.pdf 2016-07-12 00:00:00
32885 1 208068 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208068Orig1s000TAltr.p
df 2015-10-21 00:00:00
32886 1 208069 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/208069MGLtr.pdf
2015-10-13 00:00:00
32887 1 208079 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208079Orig1s000ltr.pdf
2016-02-09 00:00:00
32890 1 208090 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208090Orig1s000ltr.pdf
2016-04-27 00:00:00
32892 1 208114 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208114Orig1s000ltr.pdf
2016-04-04 00:00:00
32893 1 208135 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208135Orig1s000ltr.pdf
2016-03-02 00:00:00
32894 1 208143 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208143Orig1s000Approvedt.pdf
2016-01-20 00:00:00
32895 1 208147 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208147Orig1s000ltr.pdf
2015-10-22 00:00:00
32896 1 208183 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208183Orig1s000ltr.pdf
2015-11-13 00:00:00
32897 1 208194 SUPPL 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002lt
r.pdf 2016-06-24 00:00:00
32898 1 208215 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208215Orig1s000ltr.pdf
2016-04-13 00:00:00
32899 1 208223 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208223Orig1s000ltr.pdf
2016-02-01 00:00:00
32900 1 208246 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208246Orig1s000ltr.pdf
2016-02-25 00:00:00
32901 1 208253 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208253Orig1s000ltr.pdf
2016-04-27 00:00:00
32902 1 208271 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208271Orig1s000ltr.pdf
2016-07-22 00:00:00
32903 1 208277 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208277Orig1s000ltr.pdf
2016-05-06 00:00:00
32904 1 208286 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208286Orig1s000TAltr.p
df 2016-01-29 00:00:00
32905 1 208294 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208294Orig1s000ltr.pdf
2016-04-27 00:00:00
32906 1 208341 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208341Orig1s000ltr.pdf
2016-06-28 00:00:00
32907 1 208351 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208351Orig1s000ltr.pdf
2016-03-03 00:00:00
32908 1 208411 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208411Orig1s000ltr.pdf
2015-11-19 00:00:00
32909 1 208424 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208424Orig1s000ltr.pdf
2016-06-10 00:00:00
32910 1 208471 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208471Orig1s000ltr.pdf
2020-03-23 00:00:00
32911 1 208524 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208524Orig1s000ltr.pdf
2016-07-19 00:00:00
32912 1 208573 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208573Orig1s000ltr.pdf
2016-04-11 00:00:00
32913 1 208624 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208624Orig1s000ltr.pdf
2016-07-26 00:00:00
32914 1 208692 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208692Orig1s000ltr.pdf
2016-04-27 00:00:00
32915 1 761029 ORIG 1 0

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761029Orig1s000ltr.pdf
2016-05-31 00:00:00
32916 2 000793 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/000793s025lbl.pdf
2007-10-04 00:00:00
32917 2 004782 SUPPL 130 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf
2003-04-30 00:00:00
32918 2 004782 SUPPL 138 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf
2005-04-12 00:00:00
32919 2 004782 SUPPL 141 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf
2005-08-04 00:00:00
32920 2 004782 SUPPL 146 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf
2006-04-25 00:00:00
32921 2 004782 SUPPL 147 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf
2006-09-12 00:00:00
32922 2 004782 SUPPL 155 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf
2008-03-05 00:00:00
32923 2 004782 SUPPL 162 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
2011-11-01 00:00:00
32924 2 004782 SUPPL 167 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
2011-11-01 00:00:00
32925 2 004782 SUPPL 171 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf
2014-12-10 00:00:00
32926 2 005213 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005213s037lbl.pdf
2009-02-04 00:00:00
32927 2 005378 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/05378s20ltr.pdf
2003-04-03 00:00:00
32928 2 005378 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/005378s024lbl.pdf
2006-04-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0005378s027lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/005378s028lbl.pdf
2013-12-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/005378s030lbl.pdf
2015-04-20 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005619s021lbl.pdf
2011-03-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/005856s021lbl.pdf
2012-06-11 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf
2003-05-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06002slr039_aralen_lbl.pdf
2003-06-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006002s043lbl.pdf
2013-11-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/006035s075lbl.pdf
2007-05-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/006134s028lbl.pdf
2006-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/006134s035lbl.pdf
2014-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf
2008-11-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf
2011-07-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006188s025lbl.pdf
2016-03-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf
2013-01-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/06695slr031_mustargen_lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eu
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/7073s115lbl.pdf
2003-05-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/007073s124lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/007073s125lbl.pdf
2012-12-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007073s126lbl.pdf
2013-07-23 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,0083
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf
2011-08-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf
2014-12-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07935s030lbl.pdf
2004-11-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,0083
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumat
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumat
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008316s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008316s022lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008372s044lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf
2002-10-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008697s021lbl.pdf
2015-04-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008708s025lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008762s036lbl.pdf
2009-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.p
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32976 2 008762 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.p
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32977 2 008762 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809scf052_mvi-
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008845s065lbl.pdf
2010-11-22 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.pdf
2009-06-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf
2004-05-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09048slr037_methoxsalen_lb
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09053slr022_purinethol_lbl
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s030lbl.pdf
2007-03-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s031lbl.pdf
2007-07-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009165s033lbl.pdf
2015-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf
2009-10-15 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009170s036lbl.pdf
2009-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009175s036lbl.pdf
2013-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009175s037lbl.pdf
2009-02-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009175s038lbl.pdf
2016-03-18 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf
2014-03-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf
2005-09-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf
2007-08-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf
2011-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009330s025lbl.pdf
2010-02-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009330s030lbl.pdf
2015-07-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/09386slr013_tabloid_lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr021_myleran_lbl.pd
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33000 2 009386 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr023_myleran_lbl.pd
f 2004-02-03 00:00:00
33001 2 009402 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lb
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33002 2 009402 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09402s040lbl.pdf
2004-07-28 00:00:00
33003 2 009435 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf
2010-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009470s025lbl.pdf
2014-09-26 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf
2007-06-27 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf
2009-10-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009866s104lbl.pdf
2014-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.p
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33010 2 010151 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s022lbl.pdf
2011-11-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s073lbl.pdf
2010-12-10 00:00:00
33013 2 010187 SUPPL 74 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.p
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33014 2 010187 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,0212
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10379s47lbl.pdf
2002-05-17 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/010401s013lbl.pdf
2005-11-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/10402s047lbl.pdf
2005-01-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.p
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33019 2 010402 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/010402s055lbl.pdf
2008-03-05 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010417s027lbl.pdf
2010-02-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010571s096lbl.pdf
2005-08-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010596s021lbl.pdf
2009-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010669s030lbl.pdf
2010-05-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010669s032lbl.pdf
2011-11-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf
2004-06-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010721s058lbl.pdf
2012-10-24 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf
2002-05-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010841s020lbl.pdf
2007-02-21 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010841s021lbl.pdf
2009-04-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf
2010-06-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf
2009-09-30 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf
2009-10-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011Orig1s070s071lbl.pdf
2003-05-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011153s051lbl.pdf
2015-12-31 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s021lbl.pdf
2009-05-13 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011287s023lbl.pdf
2011-01-03 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf
2015-08-10 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf
2013-05-14 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf
2005-08-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013l
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf
2007-06-12 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf
2015-04-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011525s017lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf
2014-01-28 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/011613s027lbl.pdf
2012-12-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011641s064lbl.pdf
2008-11-07 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-
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2014-07-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf
2011-11-04 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf
2009-04-16 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011792s041lbl.pdf
2007-09-19 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011792s043lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.p
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf
2011-10-25 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/011856s107lbl.pdf
2010-07-01 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011856s123lbl.pdf
2014-07-09 00:00:00
33064 2 011909 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s038lbl.pdf
2007-08-03 00:00:00
33065 2 011961 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/11961s035lbl.pdf
2005-01-13 00:00:00
33066 2 011961 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011961s039lbl.pdf
2007-08-14 00:00:00
33067 2 012015 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf
2013-04-22 00:00:00
33068 2 012041 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/012041s033lbl.pdf
2006-11-22 00:00:00
33069 2 012041 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.p
df 2010-02-04 00:00:00
33070 2 012041 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s039lbl.pdf
2011-07-18 00:00:00
33071 2 012041 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012041s042lbledt.pdf
2014-07-09 00:00:00
33072 2 012093 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012093s052lbl.pdf
2015-01-15 00:00:00
33073 2 012097 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12097s16lbl.pdf
2002-09-03 00:00:00
33074 2 012104 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012104s032lbl.pdf
2011-08-01 00:00:00
33075 2 012142 SUPPL 109 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012142s109lbl.pdf
2012-04-02 00:00:00
33076 2 012151 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf
2012-09-17 00:00:00
33077 2 012157 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf
2007-04-06 00:00:00
33078 2 012223 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/012223Orig1s039Lbl.pdf
2015-09-03 00:00:00
33079 2 012250 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf
2010-02-25 00:00:00
33080 2 012342 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012342s059lbl.pdf
2007-08-03 00:00:00
33081 2 012342 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012342s063lbl.pdf
2010-05-28 00:00:00
33082 2 012365 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s035lbl.pdf
2009-04-03 00:00:00
33083 2 012365 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s038lbl.pdf
2009-11-17 00:00:00
33084 2 012380 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012380s031lbl.pdf
2009-04-28 00:00:00
33085 2 012380 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012380s036lbl.pdf
2016-05-20 00:00:00
33086 2 012541 SUPPL 83 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012541s083lbl.pdf
2015-06-12 00:00:00
33087 2 012583 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf
2002-06-20 00:00:00
33088 2 012616 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf
2014-01-22 00:00:00
33089 2 012616 SUPPL 75 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf
2014-03-07 00:00:00
33090 2 012623 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12623slr059_flagyl_lbl.pdf
2004-04-05 00:00:00
33091 2 012623 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf
2010-08-20 00:00:00
33092 2 012623 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012623s066lbl.pdf
2015-07-16 00:00:00
33093 2 012796 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/12796s49lbl.pdf
2003-05-14 00:00:00
33094 2 012802 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf
2010-01-20 00:00:00
33095 2 012802 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf
2014-07-08 00:00:00
33096 2 012836 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf
2005-08-03 00:00:00
33097 2 012892 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/012892Orig1s015s016lbl.pdf
2012-10-04 00:00:00
33098 2 012945 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf
2005-03-18 00:00:00
33099 2 013025 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf
2006-07-20 00:00:00
33100 2 013026 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf
2004-11-15 00:00:00
33101 2 013026 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013026s024lbl.pdf
2006-06-20 00:00:00
33102 2 013217 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013217s046lbl.pdf
2006-12-04 00:00:00
33103 2 013217 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013217s053lbl.pdf
2012-11-27 00:00:00
33104 2 013263 SUPPL 92 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf
2013-10-25 00:00:00
33105 2 013295 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.p
df 2015-07-09 00:00:00
33106 2 013400 SUPPL 86 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13400s086lbl.pdf
2004-09-21 00:00:00
33107 2 013422 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13422slr035_maxidex_lbl.pd
f 2003-05-28 00:00:00
33108 2 013684 SUPPL 91 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s091lbl.pdf
2005-06-14 00:00:00
33109 2 013718 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf
2003-06-10 00:00:00
33110 2 013718 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13718slr022_Oxandrin_lbl.p
df 2003-05-28 00:00:00
33111 2 013790 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/013790s021lbl.pdf
2011-07-28 00:00:00
33112 2 014134 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/14134s24lbl.pdf
2002-09-27 00:00:00
33113 2 014214 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf
2004-09-10 00:00:00
33114 2 014214 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf
2004-09-10 00:00:00
33115 2 014214 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014214s058lbl.pdf
2009-04-03 00:00:00
33116 2 014214 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014214s059lbl.pdf
2011-05-02 00:00:00
33117 2 014214 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014214s060lbl.pdf
2012-12-10 00:00:00
33118 2 014399 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf
2005-01-13 00:00:00
33119 2 014399 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf
2007-07-31 00:00:00
33120 2 014399 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
2012-11-26 00:00:00
33121 2 014399 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
2012-11-26 00:00:00
33122 2 014602 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/014602s047lbl.pdf
2008-06-26 00:00:00
33123 2 014602 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014602Orig1s058lbledt.pdf
2014-07-08 00:00:00
33124 2 014691 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf
2011-06-14 00:00:00
33125 2 014694 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014694s030lbl.pdf
2014-07-17 00:00:00
33126 2 014879 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf
2004-05-03 00:00:00
33127 2 014901 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s038lbl.pdf
2011-06-16 00:00:00
33128 2 014901 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s039lbl.pdf
2011-07-18 00:00:00
33129 2 015034 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/015034s039lbl.pdf
2006-01-20 00:00:00
33130 2 015034 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015034s040lbl.pdf
2008-03-07 00:00:00
33131 2 015197 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,
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33132 2 015197 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,
scm039_amicar_lbl.pdf 2004-06-25 00:00:00
33133 2 015197 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,
scm039_amicar_lbl.pdf 2004-06-25 00:00:00
33134 2 015923 SUPPL 81 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.p
df 2008-06-05 00:00:00
33135 2 015923 SUPPL 85 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/015923s085lbl.pdf
2010-12-04 00:00:00
33136 2 016023 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf
2004-04-27 00:00:00
33137 2 016023 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.p
df 2008-10-03 00:00:00
33138 2 016023 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.p
df 2009-02-04 00:00:00
33139 2 016033 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16033s11lbl.pdf
2001-08-06 00:00:00
33140 2 016042 SUPPL 77 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf
2010-03-03 00:00:00
33141 2 016042 SUPPL 78 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf
2011-03-21 00:00:00
33142 2 016059 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_0160
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33143 2 016059 SUPPL 97 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,0183
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33144 2 016059 SUPPL 99 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
2016-05-11 00:00:00
33145 2 016093 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf
2005-02-11 00:00:00
33146 2 016131 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf
2012-10-22 00:00:00
33147 2 016151 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016151s025lbl.pdf
2008-03-13 00:00:00
33148 2 016199 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016199s035lbl.pdf
2008-02-25 00:00:00
33149 2 016267 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf
2007-01-24 00:00:00
33150 2 016267 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf
2010-09-10 00:00:00
33151 2 016273 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf
2010-10-18 00:00:00
33152 2 016273 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf
2012-03-28 00:00:00
33153 2 016295 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf
2006-09-20 00:00:00
33154 2 016295 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf
2010-05-17 00:00:00
33155 2 016295 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf
2012-01-31 00:00:00
33156 2 016295 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf
2015-07-17 00:00:00
33157 2 016295 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pd
f 2016-03-28 00:00:00
33158 2 016295 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pd
f 2016-03-28 00:00:00
33159 2 016320 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf
2003-06-10 00:00:00
33160 2 016320 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.
pdf 2003-02-06 00:00:00
33161 2 016320 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.
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33162 2 016324 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.p
df 2005-07-29 00:00:00
33163 2 016324 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf
2011-05-25 00:00:00
33164 2 016324 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.p
df 2014-02-07 00:00:00
33165 2 016418 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16418s073lbl.pdf
2004-08-25 00:00:00
33166 2 016466 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf
2006-02-07 00:00:00
33167 2 016466 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf
2007-03-07 00:00:00
33168 2 016466 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf
2009-06-04 00:00:00
33169 2 016466 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf
2014-07-08 00:00:00
33170 2 016515 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf
2012-02-06 00:00:00
33171 2 016515 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf
2014-03-25 00:00:00
33172 2 016515 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf
2015-10-22 00:00:00
33173 2 016517 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016517s009lbl.pdf
2012-02-06 00:00:00
33174 2 016584 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,01690
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33175 2 016584 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf
2009-07-23 00:00:00
33176 2 016584 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016584s060lbl.pdf
2010-12-04 00:00:00
33177 2 016608 SUPPL 90 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF
2001-03-07 00:00:00
33178 2 016608 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,0189
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33179 2 016608 SUPPL 100 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
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33180 2 016608 SUPPL 101 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.p
df 2009-05-12 00:00:00
33181 2 016608 SUPPL 105 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,0189
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33182 2 016608 SUPPL 107 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,0189
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33183 2 016619 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016619s034lbl.pdf
2013-07-05 00:00:00
33184 2 016620 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lb
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33185 2 016620 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf
2007-09-19 00:00:00
33186 2 016620 SUPPL 68 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf
2009-03-17 00:00:00
33187 2 016636 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf
2015-03-02 00:00:00
33188 2 016636 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf
2015-03-02 00:00:00
33189 2 016677 SUPPL 137 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016677s137lbl.pdf
2005-05-25 00:00:00
33190 2 016682 SUPPL 105 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,0166
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33191 2 016683 SUPPL 100 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,0166
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33192 2 016692 SUPPL 95 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,0166
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33193 2 016693 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,0180
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33194 2 016694 SUPPL 119 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf
2015-01-09 00:00:00
33195 2 016721 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf
2007-11-07 00:00:00
33196 2 016784 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016784s035lbl.pdf
2014-09-19 00:00:00
33197 2 016798 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.p
df 2007-08-03 00:00:00
33198 2 016798 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.p
df 2014-07-15 00:00:00
33199 2 016812 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016812s039lbl.pdf
2012-03-09 00:00:00
33200 2 016822 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16822scs065_freamine_lbl.p
df 2004-06-01 00:00:00
33201 2 016831 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16831slr047_efudex_lbl.pdf
2004-06-25 00:00:00
33202 2 016832 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.p
df 2005-10-19 00:00:00
33203 2 016848 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16848s021lbl.pdf
2004-08-31 00:00:00
33204 2 016860 SUPPL 74 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_es
kalith_lbl.pdf 2004-04-05 00:00:00
33205 2 016862 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf
2009-10-01 00:00:00
33206 2 016909 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016909s053lbl.pdf
2016-06-13 00:00:00
33207 2 016921 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33208 2 016949 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16949s035lbl.pdf
2005-01-13 00:00:00
33209 2 016949 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016949s038lbl.pdf
2007-08-06 00:00:00
33210 2 016954 SUPPL 106 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016954s106lbl.pdf
2014-07-02 00:00:00
33211 2 016968 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16968s022lbl.pdf
2004-11-16 00:00:00
33212 2 016983 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.p
df 2015-07-09 00:00:00
33213 2 017001 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf
2003-05-06 00:00:00
33214 2 017001 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf
2003-05-06 00:00:00
33215 2 017016 SUPPL 156 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017016s156lbl.pdf
2020-03-23 00:00:00
33216 2 017029 SUPPL 108 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017029s108lbl.pdf
2008-10-03 00:00:00
33217 2 017029 SUPPL 131 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pd
f 2011-12-23 00:00:00
33218 2 017037 SUPPL 155 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf
2005-09-07 00:00:00
33219 2 017037 SUPPL 156 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf
2005-09-07 00:00:00
33220 2 017037 SUPPL 161 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017037s161lbl.pdf
2007-12-21 00:00:00
33221 2 017058 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017058s019lbl.pdf
2008-02-14 00:00:00
33222 2 017067 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017067s057lbl.pdf
2020-03-23 00:00:00
33223 2 017078 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf
2007-05-07 00:00:00
33224 2 017078 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf
2008-06-12 00:00:00
33225 2 017084 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017084s016lbl.pdf
2008-08-29 00:00:00
33226 2 017090 SUPPL 70 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf
2005-01-13 00:00:00
33227 2 017106 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17106se5-
028_atroPen_lbl.pdf 2003-06-25 00:00:00
33228 2 017106 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17106s032lbl.pdf
2004-09-21 00:00:00
33229 2 017111 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s062lbl.pdf
2008-03-17 00:00:00
33230 2 017111 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s063lbl.pdf
2008-08-29 00:00:00
33231 2 017111 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017111s066lbl.pdf
2009-07-23 00:00:00
33232 2 017116 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf
2005-05-27 00:00:00
33233 2 017116 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017116s021lbl.pdf
2008-02-14 00:00:00
33234 2 017118 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf
2004-04-27 00:00:00
33235 2 017118 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017118s019lbl.pdf
2009-01-06 00:00:00
33236 2 017122 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf
2009-10-01 00:00:00
33237 2 017243 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf
2014-02-19 00:00:00
33238 2 017243 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf
2014-01-13 00:00:00
33239 2 017243 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf
2015-05-06 00:00:00
33240 2 017340 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33241 2 017340 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33242 2 017362 SUPPL 104 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017362s104lbl.pdf
2007-01-16 00:00:00
33243 2 017376 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.p
df 2005-08-03 00:00:00
33244 2 017376 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,0184
52s025lbl.pdf 2008-03-13 00:00:00
33245 2 017376 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.p
df 2007-09-11 00:00:00
33246 2 017376 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017376s060lbl.pdf
2013-09-09 00:00:00
33247 2 017377 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17377slr057_Bactrim_lbl.pd
f 2003-02-12 00:00:00
33248 2 017377 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017377s063lbl.pdf
2007-06-07 00:00:00
33249 2 017377 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017377s067lbl.pdf
2010-07-31 00:00:00
33250 2 017377 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017377s071lbl.pdf
2012-08-31 00:00:00
33251 2 017377 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017377s074lbl.pdf
2014-07-17 00:00:00
33252 2 017378 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.p
df 2013-09-17 00:00:00
33253 2 017381 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf
2013-03-08 00:00:00
33254 2 017385 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.p
df 2013-09-17 00:00:00
33255 2 017385 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017385s060lbl.pdf
2015-01-09 00:00:00
33256 2 017385 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017385s062lbl.pdf
2016-03-22 00:00:00
33257 2 017386 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17386s32lbl.pdf
2003-06-16 00:00:00
33258 2 017391 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017391s015lbl.pdf
2011-05-25 00:00:00
33259 2 017391 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.p
df 2014-02-07 00:00:00
33260 2 017407 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s033lbl.pdf
2010-01-08 00:00:00
33261 2 017422 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf
2007-08-21 00:00:00
33262 2 017422 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s038lbl.pdf
2011-03-14 00:00:00
33263 2 017422 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s042lbl.pdf
2011-08-12 00:00:00
33264 2 017422 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017422s046lbl.pdf
2013-10-22 00:00:00
33265 2 017422 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017422Orig2s050Lbl.pdf
2016-06-17 00:00:00
33266 2 017430 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf
2004-09-10 00:00:00
33267 2 017430 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017430s032lbl.pdf
2007-08-06 00:00:00
33268 2 017441 SUPPL 171 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017441s171lbl.pdf
2009-09-17 00:00:00
33269 2 017442 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s033lbl.pdf
2009-04-16 00:00:00
33270 2 017443 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.
pdf 2012-07-19 00:00:00
33271 2 017450 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17450s52lbl.pdf
2002-08-07 00:00:00
33272 2 017451 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.p
df 2009-02-04 00:00:00
33273 2 017453 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017453s014lbl.pdf
2009-01-02 00:00:00
33274 2 017453 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017453s020lbl.pdf
2015-09-21 00:00:00
33275 2 017463 SUPPL 105 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017463s105lbl.pdf
2007-09-11 00:00:00
33276 2 017469 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_ec
onopred_lbl.pdf 2003-05-28 00:00:00
33277 2 017469 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf
2006-05-16 00:00:00
33278 2 017469 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf
2006-05-16 00:00:00
33279 2 017473 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s041lbl.pdf
2009-05-11 00:00:00
33280 2 017473 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s043lbl.pdf
2009-07-21 00:00:00
33281 2 017484 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017484s061lbl.pdf
2005-06-08 00:00:00
33282 2 017484 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
33283 2 017498 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017498s027lbl.pdf
2008-11-03 00:00:00
33284 2 017498 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017498s029lbl.pdf
2009-09-17 00:00:00
33285 2 017498 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017498s030lbl.pdf
2011-02-04 00:00:00
33286 2 017498 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017498s031lbl.pdf
2013-10-22 00:00:00
33287 2 017498 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017498s032lbl.pdf
2015-05-27 00:00:00
33288 2 017512 SUPPL 118 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf
2015-02-10 00:00:00
33289 2 017512 SUPPL 121 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf
2015-07-30 00:00:00
33290 2 017516 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.p
df 2007-08-03 00:00:00
33291 2 017522 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33292 2 017530 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf
2005-08-31 00:00:00
33293 2 017531 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s013lbl.pdf
2008-12-08 00:00:00
33294 2 017532 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf
2009-03-17 00:00:00
33295 2 017533 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s
007lbl.pdf 2012-06-04 00:00:00
33296 2 017533 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s
007lbl.pdf 2010-09-07 00:00:00
33297 2 017533 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf
2016-03-29 00:00:00
33298 2 017536 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf
2001-10-03 00:00:00
33299 2 017555 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf
2014-07-22 00:00:00
33300 2 017555 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf
2009-01-06 00:00:00
33301 2 017556 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17556s034lbl.pdf
2004-10-04 00:00:00
33302 2 017557 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042
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33303 2 017557 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042
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33304 2 017557 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042
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33305 2 017558 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf
2005-05-27 00:00:00
33306 2 017563 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.p
df 2014-05-28 00:00:00
33307 2 017577 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-
033,18211se8-016,20897slr010_ditropan_lbl.pdf 2003-04-16 00:00:00
33308 2 017579 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33309 2 017579 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33310 2 017579 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33311 2 017581 SUPPL 100 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,1
8965s9,10,20067s4,6lbl.pdf 2004-11-16 00:00:00
33312 2 017581 SUPPL 111 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,0189
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33313 2 017581 SUPPL 112 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,0200
67s019lbl.pdf 2016-05-11 00:00:00
33314 2 017588 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017588s034lbl.pdf
2009-05-11 00:00:00
33315 2 017588 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017588s037lbl.pdf
2011-05-16 00:00:00
33316 2 017588 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017588s040lbl.pdf
2014-05-28 00:00:00
33317 2 017588 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s043lbl.pdf
2016-02-02 00:00:00
33318 2 017598 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,0184
52s025lbl.pdf 2008-03-13 00:00:00
33319 2 017624 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017624s034lbl.pdf
2006-09-01 00:00:00
33320 2 017628 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.p
df 2008-01-24 00:00:00
33321 2 017634 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017634s064lbl.pdf
2005-05-25 00:00:00
33322 2 017634 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
33323 2 017634 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017634s069lbl.pdf
2015-01-09 00:00:00
33324 2 017643 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.p
df 2007-04-25 00:00:00
33325 2 017648 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017648s064lbl.pdf
2005-05-25 00:00:00
33326 2 017648 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
33327 2 017651 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017651s046lbl.pdf
2009-04-03 00:00:00
33328 2 017651 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pd
f 2011-12-23 00:00:00
33329 2 017681 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf
2004-06-15 00:00:00
33330 2 017681 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf
2005-11-30 00:00:00
33331 2 017683 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,0176
83s008lbl.pdf 2011-03-29 00:00:00
33332 2 017691 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf
2001-10-03 00:00:00
33333 2 017691 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf
2001-10-03 00:00:00
33334 2 017692 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017692s018lbl.pdf
2020-03-23 00:00:00
33335 2 017692 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017692s021lbl.pdf
2020-03-23 00:00:00
33336 2 017693 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017693s026lbl.pdf
2014-10-15 00:00:00
33337 2 017694 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017694s050lbl.pdf
2005-10-25 00:00:00
33338 2 017703 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.p
df 2005-10-19 00:00:00
33339 2 017735 SUPPL 107 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf
2012-07-13 00:00:00
33340 2 017735 SUPPL 117 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,0189
85s063lbl.pdf 2015-11-04 00:00:00
33341 2 017766 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017766s030lbl.pdf
2006-05-05 00:00:00
33342 2 017768 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017768Orig1s041lbl.pdf
2014-07-31 00:00:00
33343 2 017771 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017771s035lbl.pdf
2014-02-12 00:00:00
33344 2 017781 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf
2001-10-03 00:00:00
33345 2 017783 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf
2008-11-07 00:00:00
33346 2 017783 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf
2011-02-07 00:00:00
33347 2 017783 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf
2013-10-22 00:00:00
33348 2 017806 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017806s025lbl.pdf
2011-08-26 00:00:00
33349 2 017808 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017808s030lbl.pdf
2009-12-10 00:00:00
33350 2 017812 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.p
df 2011-10-25 00:00:00
33351 2 017814 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,0183
32s030lbl.pdf 2007-02-02 00:00:00
33352 2 017814 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf
2016-05-11 00:00:00
33353 2 017821 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017821s045lbl.pdf
2003-03-05 00:00:00
33354 2 017821 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017821s051lbl.pdf
2013-04-16 00:00:00
33355 2 017823 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17823s023lbl.pdf
2004-10-04 00:00:00
33356 2 017830 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019
s030lbl.pdf 2014-02-25 00:00:00
33357 2 017830 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019
s030lbl.pdf 2014-02-25 00:00:00
33358 2 017831 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17831slr053_didronel_lbl.p
df 2004-04-05 00:00:00
33359 2 017831 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017831s055lbl.pdf
2010-01-04 00:00:00
33360 2 017831 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017831s056lbl.pdf
2013-04-23 00:00:00
33361 2 017831 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s057lbl.pdf
2015-03-19 00:00:00
33362 2 017854 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17854s047lbl.pdf
2004-07-28 00:00:00
33363 2 017854 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017854s055lbl.pdf
2010-11-26 00:00:00
33364 2 017862 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063lbl.pdf
2010-11-26 00:00:00
33365 2 017892 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017892s047lbl.pdf
2014-09-22 00:00:00
33366 2 017911 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s065_lbl.pdf
2006-10-11 00:00:00
33367 2 017911 SUPPL 72 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017911s072lbl.pdf
2009-04-03 00:00:00
33368 2 017911 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s074lbl.pdf
2010-12-26 00:00:00
33369 2 017919 SUPPL 86 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig
1s086,018985Orig1s050lbl.pdf 2013-10-04 00:00:00
33370 2 017922 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,0199
55s010ltr.pdf 2005-11-16 00:00:00
33371 2 017922 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.p
df 2015-11-19 00:00:00
33372 2 017943 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17943s16lbl.pdf
2002-08-26 00:00:00
33373 2 017950 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17950slr021_westcort_lbl.p
df 2003-03-25 00:00:00
33374 2 017955 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33375 2 017962 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf
2005-11-17 00:00:00
33376 2 017962 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf
2012-01-06 00:00:00
33377 2 017963 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.p
df 2008-07-29 00:00:00
33378 2 017963 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.p
df 2009-11-23 00:00:00
33379 2 017963 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017963s064lbl.pdf
2011-03-21 00:00:00
33380 2 017970 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf 1998-
10-29 00:00:00
33381 2 017970 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf
2002-05-16 00:00:00
33382 2 017970 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/17970S46LBL.PDF
2000-06-29 00:00:00
33383 2 017970 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf
2002-05-16 00:00:00
33384 2 017970 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-
970S049FA_Nolvadex_prntlbl.pdf 2004-06-10 00:00:00
33385 2 017970 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf
2005-03-23 00:00:00
33386 2 017970 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017970s054lbl.pdf
2006-03-14 00:00:00
33387 2 018008 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,0193
08s023lbl.pdf 2007-04-25 00:00:00
33388 2 018008 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,0193
08s027lbl.pdf 2013-09-11 00:00:00
33389 2 018012 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018012s24lbl.pdf
2003-04-11 00:00:00
33390 2 018012 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018012s27lbl.pdf
2007-07-16 00:00:00
33391 2 018012 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s031lbl.pdf
2014-07-29 00:00:00
33392 2 018013 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf
2007-07-16 00:00:00
33393 2 018013 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.p
df 2012-10-26 00:00:00
33394 2 018024 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018024s040lbl.pdf
2005-08-31 00:00:00
33395 2 018027 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf
2002-10-07 00:00:00
33396 2 018027 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf
2002-10-07 00:00:00
33397 2 018027 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018027s059lbl.pdf
2016-06-01 00:00:00
33398 2 018029 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,
021284s6s8lbl.pdf 2006-08-09 00:00:00
33399 2 018029 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,0212
84s011lbl.pdf 2007-05-01 00:00:00
33400 2 018029 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.p
df 2010-11-17 00:00:00
33401 2 018029 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf
2013-12-17 00:00:00
33402 2 018031 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf
2011-03-21 00:00:00
33403 2 018035 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf
2009-07-09 00:00:00
33404 2 018035 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf
2010-10-25 00:00:00
33405 2 018037 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
33406 2 018052 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018052Orig1s032lbl.pdf
2015-01-12 00:00:00
33407 2 018057 SUPPL 81 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf
2012-01-11 00:00:00
33408 2 018063 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf
2011-06-27 00:00:00
33409 2 018063 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf
2013-07-15 00:00:00
33410 2 018066 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018066Orig1s020lbl.pdf
2013-09-24 00:00:00
33411 2 018074 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018074s034lbl.pdf
2012-02-24 00:00:00
33412 2 018081 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s3
2,19680s19,20593s11,21168s9lbl.pdf 2006-01-13 00:00:00
33413 2 018081 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33
,19680s22,20593s15,21168s14lbl.pdf 2006-10-18 00:00:00
33414 2 018081 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
33415 2 018081 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
33416 2 018081 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s054,018082s038lbl.p
df 2013-03-04 00:00:00
33417 2 018081 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s057,018082s040lbl.p
df 2013-07-02 00:00:00
33418 2 018081 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.p
df 2014-08-22 00:00:00
33419 2 018081 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.p
df 2015-03-17 00:00:00
33420 2 018081 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.p
df 2015-10-06 00:00:00
33421 2 018081 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.p
df 2016-02-23 00:00:00
33422 2 018082 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s3
2,19680s19,20593s11,21168s9lbl.pdf 2006-01-13 00:00:00
33423 2 018082 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33
,19680s22,20593s15,21168s14lbl.pdf 2006-10-18 00:00:00
33424 2 018082 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018081s047,018082s032lbl.p
df 2009-05-12 00:00:00
33425 2 018082 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.p
df 2014-06-23 00:00:00
33426 2 018082 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
33427 2 018082 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pd
f 2011-10-12 00:00:00
33428 2 018082 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s054,018082s038lbl.p
df 2013-03-04 00:00:00
33429 2 018082 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s057,018082s040lbl.p
df 2013-07-02 00:00:00
33430 2 018082 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.p
df 2014-12-03 00:00:00
33431 2 018082 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.p
df 2015-01-08 00:00:00
33432 2 018086 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18086s58lbl.pdf
2002-04-29 00:00:00
33433 2 018086 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf
2006-05-01 00:00:00
33434 2 018086 SUPPL 75 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018086s075lbl.pdf
2011-09-30 00:00:00
33435 2 018101 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.p
df 2009-02-04 00:00:00
33436 2 018117 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018117s030lbl.pdf
2007-04-20 00:00:00
33437 2 018117 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr034_azmacort_lbl.p
df 2004-01-15 00:00:00
33438 2 018124 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf
2005-04-28 00:00:00
33439 2 018132 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.p
df 2014-05-15 00:00:00
33440 2 018141 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018141s029lbl.pdf
2007-09-06 00:00:00
33441 2 018147 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf
2007-07-06 00:00:00
33442 2 018147 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042
lbl.pdf 2015-03-04 00:00:00
33443 2 018147 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042
lbl.pdf 2015-03-04 00:00:00
33444 2 018147 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf
2016-05-11 00:00:00
33445 2 018150 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18150s019lbl.pdf
2004-07-28 00:00:00
33446 2 018150 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018150s025lbl.pdf
2011-06-29 00:00:00
33447 2 018150 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018150s026lbl.pdf
2012-01-26 00:00:00
33448 2 018152 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_es
kalith_lbl.pdf 2004-04-05 00:00:00
33449 2 018163 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf
2008-02-26 00:00:00
33450 2 018164 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,1
8965s9,10,20067s4,6lbl.pdf 2004-11-16 00:00:00
33451 2 018164 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,1
8965s9,10,20067s4,6lbl.pdf 2004-11-16 00:00:00
33452 2 018164 SUPPL 55 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,0181
64s055, 017581s105lbl.pdf 2006-03-14 00:00:00
33453 2 018164 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,0189
65s014,020067s011lbl.pdf 2006-01-25 00:00:00
33454 2 018164 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s
16,20067s14lbl.pdf 2007-09-26 00:00:00
33455 2 018200 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-
200S024_Midamor_Prntlbl.pdf 2002-03-21 00:00:00
33456 2 018207 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18207s030lbl.pdf
2005-01-13 00:00:00
33457 2 018211 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-
033,18211se8-016,20897slr010_ditropan_lbl.pdf 2003-04-16 00:00:00
33458 2 018211 SUPPL 17 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,0208
97s018lbl.pdf 2008-02-14 00:00:00
33459 2 018225 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-
225S018_Bumex_prntlbl.pdf 2002-10-29 00:00:00
33460 2 018226 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-
225S018_Bumex_prntlbl.pdf 2002-10-29 00:00:00
33461 2 018226 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-
225S018_Bumex_prntlbl.pdf 2002-10-29 00:00:00
33462 2 018239 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18239s25lbl.pdf
2003-04-14 00:00:00
33463 2 018240 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf
2012-11-06 00:00:00
33464 2 018261 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf
2007-07-30 00:00:00
33465 2 018261 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf
2014-10-03 00:00:00
33466 2 018276 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.p
df 2011-06-07 00:00:00
33467 2 018281 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF
2001-03-07 00:00:00
33468 2 018281 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,0189
27s038,020234s026lbl.pdf 2015-09-03 00:00:00
33469 2 018281 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,0189
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33470 2 018281 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s
050,018927s041s042,020234s031s033lbl.pdf 2011-03-07 00:00:00
33471 2 018303 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s033lbl.pdf
2008-07-29 00:00:00
33472 2 018303 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018303s034lbl.pdf
2009-09-17 00:00:00
33473 2 018303 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf
2011-03-21 00:00:00
33474 2 018304 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf
2015-07-13 00:00:00
33475 2 018309 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_to
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33476 2 018332 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_0160
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33477 2 018332 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018332s032lbl.pdf
2009-04-03 00:00:00
33478 2 018332 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf
2016-05-11 00:00:00
33479 2 018332 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf
2016-05-11 00:00:00
33480 2 018343 SUPPL 82 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s082lbl.pdf
2011-05-23 00:00:00
33481 2 018343 SUPPL 83 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s083lbl.pdf
2011-12-14 00:00:00
33482 2 018343 SUPPL 85 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018343s085lbl.pdf
2015-01-09 00:00:00
33483 2 018343 SUPPL 86 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf
2015-06-22 00:00:00
33486 2 018353 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s026lbl.pdf
2013-08-21 00:00:00
33487 2 018353 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018353s027lbl.pdf
2015-07-16 00:00:00
33488 2 018388 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018388s084lbl.pdf
2014-01-16 00:00:00
33489 2 018422 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf
2003-04-14 00:00:00
33490 2 018422 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018422s055lbl.pdf
2016-04-07 00:00:00
33491 2 018445 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018445s057lbl.pdf
2006-01-25 00:00:00
33492 2 018458 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s014lbl.pdf
2011-03-07 00:00:00
33493 2 018461 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf
2012-03-05 00:00:00
33494 2 018469 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pd
f 2004-05-27 00:00:00
33495 2 018469 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pd
f 2004-05-27 00:00:00
33496 2 018469 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf
2004-12-30 00:00:00
33497 2 018469 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf
2015-11-12 00:00:00
33498 2 018482 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf
2011-09-30 00:00:00
33499 2 018482 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf
2015-01-29 00:00:00
33500 2 018498 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18498s8lbl.pdf
2002-09-03 00:00:00
33501 2 018511 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf
2011-09-29 00:00:00
33502 2 018514 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf
2014-11-04 00:00:00
33503 2 018533 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018533s040lbl.pdf
2013-07-25 00:00:00
33504 2 018554 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18554s23lbl.pdf
2003-04-14 00:00:00
33505 2 018561 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,0185
63s057,018564s059,019345s044lbl.pdf 2016-02-23 00:00:00
33506 2 018565 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf
2009-05-19 00:00:00
33507 2 018582 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18582scs031_procalAmine_lb
l.pdf 2004-01-15 00:00:00
33508 2 018584 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18584s27lbl.pdf
2003-04-14 00:00:00
33509 2 018586 SUPPL 4 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18586slr004_topicort_lbl.p
df 2004-05-04 00:00:00
33510 2 018596 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18596slr030_intal_lbl.pdf
2004-04-05 00:00:00
33511 2 018602 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018602s065lbl.pdf
2014-11-25 00:00:00
33512 2 018603 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/18603s19lbl.pdf
1998-06-02 00:00:00
33513 2 018603 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18603slr027_zovirax_lbl.pd
f 2004-05-27 00:00:00
33514 2 018604 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf
2012-06-22 00:00:00
33515 2 018604 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf
2012-06-22 00:00:00
33516 2 018609 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf
2003-04-14 00:00:00
33517 2 018612 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-
612S025_Nicorette_prntlbl.pdf 1998-12-23 00:00:00
33518 2 018612 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pd
f 2007-06-27 00:00:00
33519 2 018612 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.p
df 2012-03-28 00:00:00
33520 2 018612 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065,
020066Orig1s046lbl.pdf 2014-01-16 00:00:00
33521 2 018612 SUPPL 68 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig
1s049lbl.pdf 2013-11-07 00:00:00
33522 2 018612 SUPPL 73 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072,
s073, 020066Orig1s053, s054lbl .pdf 2014-08-05 00:00:00
33523 2 018612 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018612s076lbl.pdf
2015-11-02 00:00:00
33524 2 018631 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018631s034lbl.pdf
2005-04-12 00:00:00
33525 2 018631 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf
2012-07-10 00:00:00
33526 2 018631 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018631s040lbl.pdf
2015-03-27 00:00:00
33527 2 018632 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf
2016-06-01 00:00:00
33528 2 018644 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,
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33529 2 018644 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s036lbl.pdf
2007-08-03 00:00:00
33530 2 018644 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf
2009-07-06 00:00:00
33531 2 018644 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s042lbl.pdf
2011-05-23 00:00:00
33532 2 018644 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.p
df 2013-03-26 00:00:00
33533 2 018644 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf
2013-12-24 00:00:00
33534 2 018644 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.p
df 2014-12-17 00:00:00
33535 2 018644 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s049lbl.pdf
2014-07-22 00:00:00
33536 2 018644 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.p
df 2016-04-27 00:00:00
33537 2 018647 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018647s024lbl.pdf
2011-06-27 00:00:00
33538 2 018647 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf
2013-07-15 00:00:00
33539 2 018649 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18649slr040_viaflex_lbl.pd
f 2004-01-15 00:00:00
33540 2 018651 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf
2006-06-28 00:00:00
33541 2 018657 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidaz
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33542 2 018657 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018657s034lbl.pdf
2015-07-16 00:00:00
33543 2 018658 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018658s022lbl.pdf
2007-10-04 00:00:00
33544 2 018662 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s043lbl.pdf
2002-05-02 00:00:00
33545 2 018662 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s44lbl.pdf
2001-10-30 00:00:00
33546 2 018662 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf
2001-12-31 00:00:00
33547 2 018662 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s046lbl.pdf
2002-02-15 00:00:00
33548 2 018662 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_l
bl.pdf 2003-08-29 00:00:00
33549 2 018662 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018662s058lbl.pdf
2007-10-10 00:00:00
33550 2 018662 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf
2009-06-10 00:00:00
33551 2 018662 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s060lbl.pdf
2010-02-04 00:00:00
33552 2 018671 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018671s016lbl.pdf
2008-06-18 00:00:00
33553 2 018677 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf
2006-05-16 00:00:00
33554 2 018680 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18680s55lbl.pdf
2003-04-30 00:00:00
33555 2 018680 SUPPL 66 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018680s066lbl.pdf
2013-06-18 00:00:00
33556 2 018683 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018683s030lbl.pdf
2005-04-29 00:00:00
33557 2 018701 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.p
df 2007-05-07 00:00:00
33558 2 018701 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.p
df 2008-06-05 00:00:00
33559 2 018701 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.p
df 2008-08-29 00:00:00
33560 2 018701 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018701s062lbl.pdf
2010-12-04 00:00:00
33561 2 018701 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.p
df 2011-03-04 00:00:00
33562 2 018702 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf
2004-05-25 00:00:00
33563 2 018704 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.p
df 2008-07-29 00:00:00
33564 2 018704 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018704s025lbl.pdf
2013-01-02 00:00:00
33565 2 018704 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018704s026lbl.pdf
2013-03-15 00:00:00
33566 2 018705 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018705s019lbl.pdf
2015-01-30 00:00:00
33567 2 018707 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf
2003-04-07 00:00:00
33568 2 018707 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018707s012lbl.pdf
2011-04-06 00:00:00
33569 2 018708 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018708s017lbl.pdf
2007-11-07 00:00:00
33570 2 018708 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018708s018lbl.pdf
2010-04-20 00:00:00
33571 2 018714 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf
2004-07-21 00:00:00
33572 2 018716 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018716s026lbl.pdf
2010-11-22 00:00:00
33573 2 018723 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s3
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33574 2 018723 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33
,19680s22,20593s15,21168s14lbl.pdf 2006-10-18 00:00:00
33575 2 018723 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018723s039lbl.pdf
2009-05-12 00:00:00
33576 2 018723 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s049lbl.pdf
2013-07-02 00:00:00
33577 2 018723 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,0187
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33578 2 018723 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.p
df 2015-03-17 00:00:00
33579 2 018723 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s055lbl.pdf
2015-10-06 00:00:00
33580 2 018726 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf
2002-09-03 00:00:00
33581 2 018726 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf
2002-09-03 00:00:00
33582 2 018731 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf
2003-04-14 00:00:00
33583 2 018731 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018731s048lbl.pdf
2007-09-26 00:00:00
33584 2 018733 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018733s015lbl.pdf
2011-03-04 00:00:00
33585 2 018735 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018735s054lbl.pdf
2012-08-02 00:00:00
33586 2 018735 SUPPL 56 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.p
df 2015-07-09 00:00:00
33587 2 018741 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf
2005-10-14 00:00:00
33588 2 018741 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf
2006-08-29 00:00:00
33589 2 018741 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf
2014-08-15 00:00:00
33590 2 018748 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18748s11lbl.pdf
2003-04-15 00:00:00
33591 2 018748 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,0205
19s016lbl.pdf 2013-07-11 00:00:00
33592 2 018760 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018760s027lbl.pdf
2008-11-07 00:00:00
33593 2 018766 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015lbl.pdf
2010-08-28 00:00:00
33594 2 018771 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18771S12lbl.pdf
2002-03-20 00:00:00
33595 2 018771 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018771s017lbl.pdf
2008-02-25 00:00:00
33596 14 018780 SUPPL 67 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33597 14 018780 SUPPL 78 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33598 14 018780 SUPPL 128 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33599 14 018780 SUPPL 132 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33600 14 018780 SUPPL 150 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33601 14 018780 SUPPL 152 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33602 14 018781 SUPPL 80 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33603 14 018781 SUPPL 85 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33604 14 018781 SUPPL 114 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33605 14 018781 SUPPL 118 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33606 14 018781 SUPPL 121 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33607 2 018782 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018782s036lbl.pdf
2013-06-03 00:00:00
33608 2 018796 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018796s014lbl.pdf
2008-06-05 00:00:00
33609 2 018817 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf
2009-07-23 00:00:00
33610 2 018817 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018817s022lbl.pdf
2010-04-19 00:00:00
33611 2 018817 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s024lbl.pdf
2011-06-30 00:00:00
33612 2 018817 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s027lbl.pdf
2011-11-04 00:00:00
33613 2 018817 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018817s031lbl.pdf
2013-10-31 00:00:00
33614 2 018826 SUPPL 45 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.p
df 2014-05-15 00:00:00
33615 2 018827 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf
2003-04-15 00:00:00
33616 2 018827 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf
2005-07-29 00:00:00
33617 2 018828 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf
2003-04-15 00:00:00
33618 2 018828 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf
2003-04-15 00:00:00
33619 2 018828 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,0199
09s020lbl.pdf 2005-12-15 00:00:00
33620 2 018829 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf
2016-05-11 00:00:00
33621 2 018840 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
33622 2 018841 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf
2002-01-25 00:00:00
33623 2 018841 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18841slr020_Daypro_lbl.pdf
2003-04-17 00:00:00
33624 2 018841 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018841s021lbl.pdf
2006-01-20 00:00:00
33625 2 018841 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf
2016-05-11 00:00:00
33626 2 018858 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf
2016-05-11 00:00:00
33627 2 018869 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18869SE10lbl.pdf
2000-08-22 00:00:00
33628 2 018869 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018869s014lbl.pdf
2006-01-27 00:00:00
33629 2 018878 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018878s023lbl.pdf
2006-02-07 00:00:00
33630 2 018878 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018878s027lbl.pdf
2010-01-20 00:00:00
33631 2 018883 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.p
df 2013-02-01 00:00:00
33632 2 018883 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.p
df 2013-04-19 00:00:00
33633 2 018883 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.p
df 2014-04-28 00:00:00
33634 2 018887 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18887slr020_intal_lbl.pdf
2004-04-05 00:00:00
33635 2 018890 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018890s050lbl.pdf
2015-07-16 00:00:00
33636 2 018891 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018891s027lbl.pdf
2010-05-07 00:00:00
33637 2 018893 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018893s025lbl.pdf
2014-09-03 00:00:00
33638 2 018900 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s031lbl.pdf
2015-12-10 00:00:00
33639 2 018900 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s032lbl.pdf
2015-07-16 00:00:00
33640 2 018902 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018902s027lbl.pdf
2016-03-14 00:00:00
33641 2 018905 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018905s024lbl.pdf
2015-07-09 00:00:00
33642 2 018916 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018916s060lbl.pdf
2013-02-14 00:00:00
33643 2 018916 SUPPL 66 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf
2016-04-12 00:00:00
33644 2 018916 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf
2016-04-12 00:00:00
33645 2 018917 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018917s024lbl.pdf
2007-09-11 00:00:00
33646 2 018920 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18920s024lbl.pdf
2002-07-08 00:00:00
33647 2 018922 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.p
df 2006-01-20 00:00:00
33648 2 018922 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018922s023lbl.pdf
2015-07-27 00:00:00
33649 2 018925 SUPPL 7 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.p
df 2010-04-19 00:00:00
33650 2 018927 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,0189
27s038,020234s026lbl.pdf 2015-09-03 00:00:00
33651 2 018927 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018927s039lbl.pdf
2007-12-12 00:00:00
33652 2 018927 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,0189
27s040,020234s030lbl.pdf 2014-09-19 00:00:00
33653 2 018927 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.p
df 2009-05-12 00:00:00
33654 2 018927 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,0189
27s046,020234s038lbl.pdf 2013-03-08 00:00:00
33655 2 018932 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018932s017lbl.pdf
2013-10-08 00:00:00
33656 2 018936 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s61s65,20101s27,20974
s1lbl.pdf 2002-07-29 00:00:00
33657 2 018936 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf
2002-06-12 00:00:00
33658 2 018936 SUPPL 75 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
2009-03-20 00:00:00
33659 2 018936 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf
2006-09-21 00:00:00
33660 2 018936 SUPPL 83 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,0212
35s010lbl.pdf 2008-03-13 00:00:00
33661 2 018936 SUPPL 89 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf
2009-06-24 00:00:00
33662 2 018936 SUPPL 93 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf
2011-04-04 00:00:00
33663 2 018936 SUPPL 95 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf
2011-04-04 00:00:00
33664 2 018936 SUPPL 96 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.p
df 2011-06-16 00:00:00
33665 2 018936 SUPPL 97 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s
020lbl.pdf 2013-01-07 00:00:00
33666 2 018936 SUPPL 98 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s
020lbl.pdf 2013-01-07 00:00:00
33667 2 018936 SUPPL 101 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021l
bl.pdf 2013-07-30 00:00:00
33668 2 018936 SUPPL 105 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.p
df 2014-07-23 00:00:00
33669 2 018948 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf
2002-04-15 00:00:00
33670 2 018948 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.p
df 2007-03-31 00:00:00
33671 2 018948 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,0201
82s013lbl.pdf 2015-06-04 00:00:00
33672 2 018956 SUPPL 95 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.p
df 2015-07-09 00:00:00
33673 2 018962 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18962slr011lbl.pdf
2002-12-06 00:00:00
33674 2 018965 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,1
8965s9,10,20067s4,6lbl.pdf 2004-11-16 00:00:00
33675 2 018965 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf
2016-05-11 00:00:00
33676 2 018972 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018972s044lbl.pdf
2011-11-14 00:00:00
33677 2 018972 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s048lbl.pdf
2014-01-23 00:00:00
33678 2 018983 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018983s047lbl.pdf
2013-08-19 00:00:00
33679 2 018985 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig
1s086,018985Orig1s050lbl.pdf 2013-10-04 00:00:00
33680 2 018989 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018989Orig1s079lbl.pdf
2012-03-27 00:00:00
33681 2 018998 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-
998S058_Vasotec_prntlbl.pdf 2001-11-27 00:00:00
33682 2 018998 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-
998S059_Vasotec_prntlbl.pdf 2001-02-13 00:00:00
33683 2 018998 SUPPL 76 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s076lbl.pdf
2012-02-22 00:00:00
33684 2 018998 SUPPL 79 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018998s079lbl.pdf
2015-01-09 00:00:00
33685 2 018998 SUPPL 80 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018998s080lbl.pdf
2015-08-26 00:00:00
33686 2 019010 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s036lbl.pdf
2011-01-20 00:00:00
33687 2 019011 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019011s025lbl.pdf
2013-09-23 00:00:00
33688 2 019012 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19012s28lbl.pdf
2003-04-16 00:00:00
33689 2 019012 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019012s046lbl.pdf
2012-03-27 00:00:00
33690 2 019022 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf
2015-01-08 00:00:00
33691 2 019032 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019032s021lbl.pdf
2013-07-05 00:00:00
33692 2 019034 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf
2011-07-06 00:00:00
33693 2 019049 SUPPL 11 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
2002-06-10 00:00:00
33694 2 019081 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_
lbl.pdf 2004-06-01 00:00:00
33695 2 019081 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf
2012-07-13 00:00:00
33696 2 019090 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.p
df 2009-03-27 00:00:00
33697 2 019090 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.p
df 2009-10-06 00:00:00
33698 2 019111 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019111s018lbl.pdf
2015-04-02 00:00:00
33699 2 019125 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.pdf
2014-10-30 00:00:00
33700 2 019129 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf
2011-03-28 00:00:00
33701 2 019151 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019151s012lbl.pdf
2013-03-26 00:00:00
33702 2 019157 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019157s020lbl.pdf
2013-10-17 00:00:00
33703 2 019201 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf
2006-01-25 00:00:00
33704 2 019201 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf
2009-03-17 00:00:00
33705 2 019201 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf
2011-03-04 00:00:00
33706 2 019201 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf
2016-05-11 00:00:00
33707 2 019216 SUPPL 21 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf
2006-01-13 00:00:00
33708 2 019216 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019216s025lbl.pdf
2013-02-14 00:00:00
33709 2 019221 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s042lbl.pdf
2012-02-22 00:00:00
33710 2 019221 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s043lbl.pdf
2012-09-14 00:00:00
33711 2 019257 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf
2002-04-15 00:00:00
33712 2 019258 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019258Orig1s023lbl.pdf
2016-01-15 00:00:00
33713 2 019268 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019268s041lbl.pdf
2009-10-06 00:00:00
33714 2 019270 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf
2006-02-22 00:00:00
33715 2 019281 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019281s025lbl.pdf
2009-01-02 00:00:00
33716 2 019281 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019281s030lbl.pdf
2011-01-31 00:00:00
33717 2 019281 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019281s033lbl.pdf
2015-04-14 00:00:00
33718 2 019297 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf
2009-02-12 00:00:00
33719 2 019297 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf
2010-06-24 00:00:00
33720 2 019304 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19304-
S005_Tricor_prntlbl.pdf 2000-04-11 00:00:00
33721 2 019308 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,0193
08s023lbl.pdf 2007-04-25 00:00:00
33722 2 019308 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,0193
08s027lbl.pdf 2013-09-11 00:00:00
33723 2 019316 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019316s011lbl.pdf
2006-12-14 00:00:00
33724 2 019334 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf
2009-01-06 00:00:00
33725 2 019334 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf
2009-01-06 00:00:00
33726 2 019339 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019339s047lbl.pdf
2011-12-23 00:00:00
33727 2 019345 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,0185
63s057,018564s059,019345s044lbl.pdf 2016-02-23 00:00:00
33728 2 019367 SUPPL 22 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et
al_lbl.pdf 2005-08-31 00:00:00
33730 2 019384 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf
2004-07-28 00:00:00
33731 2 019384 SUPPL 50 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s049s050lbl.pdf
2008-10-03 00:00:00
33732 2 019384 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s056lbl.pdf
2011-03-04 00:00:00
33733 2 019385 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax
_lbl.pdf 2003-10-10 00:00:00
33734 2 019386 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019386s039lbl.pdf
2007-11-07 00:00:00
33735 2 019389 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19389s23lbl.pdf
2003-04-15 00:00:00
33736 2 019389 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019389s027lbl.pdf
2005-11-01 00:00:00
33737 2 019404 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s14lbl.pdf
2003-04-15 00:00:00
33738 2 019404 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s17lbl.pdf
2003-04-15 00:00:00
33739 2 019404 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019404s026lbl.pdf
2012-07-26 00:00:00
33740 2 019422 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf
2014-01-14 00:00:00
33741 2 019425 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019425s021lbl.pdf
2010-11-22 00:00:00
33742 2 019429 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019429s035lbl.pdf
2013-05-14 00:00:00
33743 2 019430 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19430s12lbl.pdf
2003-04-15 00:00:00
33744 2 019430 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/19430Orig1s058lbl.pdf
2014-07-30 00:00:00
33745 2 019430 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019430s059lbl.pdf
2014-05-02 00:00:00
33746 2 019430 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf
2016-05-20 00:00:00
33747 2 019452 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19425s15lbl.pdf
1999-08-18 00:00:00
33748 2 019452 SUPPL 18 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19452scp018_dermasmoothe_l
bl.pdf 2003-05-29 00:00:00
33749 2 019452 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf
2005-11-17 00:00:00
33750 2 019452 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf
2005-11-17 00:00:00
33751 2 019462 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf
2003-04-24 00:00:00
33752 2 019462 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf
2010-03-26 00:00:00
33753 2 019462 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf
2011-06-07 00:00:00
33754 2 019462 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf
2014-02-06 00:00:00
33755 2 019463 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19463s22lbl.pdf
2003-04-15 00:00:00
33756 2 019463 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19463slr026_timoptic_lbl.p
df 2003-12-29 00:00:00
33757 2 019463 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019463s027lbl.pdf
2006-06-06 00:00:00
33758 2 019463 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019463s028lbl.pdf
2011-09-30 00:00:00
33759 2 019481 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019481s013lbl.pdf
2015-11-04 00:00:00
33760 2 019501 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf
2005-06-23 00:00:00
33761 2 019501 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf
2005-06-23 00:00:00
33762 2 019507 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019507s007lbl.pdf
2009-07-08 00:00:00
33763 2 019507 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019507s008lbl.pdf
2011-08-24 00:00:00
33764 2 019510 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19510lbl.pdf 2003-
04-30 00:00:00
33765 2 019510 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF
2001-03-14 00:00:00
33766 2 019510 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,0202
49s013lbl.pdf 2007-11-07 00:00:00
33767 2 019516 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf
2010-05-17 00:00:00
33768 2 019516 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s036lbl.pdf
2012-07-12 00:00:00
33769 2 019516 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s037lbl.pdf
2012-07-13 00:00:00
33770 2 019516 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf
2014-04-16 00:00:00
33771 2 019516 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516Orig1s043lbl.pdf
2014-10-30 00:00:00
33772 2 019525 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19525S010lbl.pdf
2005-03-11 00:00:00
33773 2 019527 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf
2002-06-06 00:00:00
33774 2 019527 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19527s027lbl.pdf
2004-12-03 00:00:00
33775 2 019527 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019527s028lbl.pdf
2007-11-07 00:00:00
33776 2 019531 SUPPL 2 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019531s002lbl.pdf
2014-12-05 00:00:00
33777 2 019537 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf
2000-08-30 00:00:00
33778 2 019537 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780s
lr012,014,015_cipro_lbl.pdf 2004-04-05 00:00:00
33779 2 019537 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847s
e5-027,20780se5-013_cipro_lbl.pdf 2004-04-05 00:00:00
33780 2 019537 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780s
lr012,014,015_cipro_lbl.pdf 2004-04-05 00:00:00
33781 2 019537 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s
035,20780s016lbl.pdf 2005-01-11 00:00:00
33782 2 019537 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,01
8lbl.pdf 2004-07-21 00:00:00
33783 2 019537 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s057,020780s019lbl.p
df 2005-05-20 00:00:00
33784 2 019537 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857
s41,020780s20,021473s13lbl.pdf 2005-11-17 00:00:00
33785 2 019537 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s7019847441985751207
80282147325L.pdf 2009-05-11 00:00:00
33786 2 019537 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.p
df 2009-04-16 00:00:00
33787 2 019537 SUPPL 74 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.p
df 2011-11-16 00:00:00
33788 2 019537 SUPPL 78 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.p
df 2011-06-14 00:00:00
33789 2 019537 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,0198
57s059,020780s038,021473s033lbl.pdf 2011-11-04 00:00:00
33790 2 019537 SUPPL 83 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.p
df 2015-03-02 00:00:00
33791 2 019537 SUPPL 86 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s086lbl.pdf
2016-07-26 00:00:00
33792 2 019543 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf
2002-07-17 00:00:00
33793 2 019543 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf
2002-07-17 00:00:00
33794 2 019543 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543slr014_Elocon_lbl.pdf
2002-12-15 00:00:00
33795 2 019543 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019543s024lbl.pdf
2013-04-01 00:00:00
33796 2 019555 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf
2001-10-03 00:00:00
33797 2 019555 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf
2001-10-03 00:00:00
33798 2 019555 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019555s026lbl.pdf
2006-08-28 00:00:00
33799 2 019558 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf
2015-09-03 00:00:00
33801 2 019579 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
2003-03-20 00:00:00
33802 2 019579 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,0199
64s030lbl.pdf 2013-09-27 00:00:00
33803 2 019583 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019583s025lbl.pdf
2006-01-25 00:00:00
33804 2 019591 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf
2003-01-10 00:00:00
33805 2 019591 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf
2003-01-10 00:00:00
33806 2 019591 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591s19lbl_Lariam.pdf
2003-07-09 00:00:00
33807 2 019591 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf
2008-10-03 00:00:00
33808 2 019591 SUPPL 25 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf
2008-10-03 00:00:00
33809 2 019596 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.p
df 2010-09-07 00:00:00
33810 2 019596 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.p
df 2007-09-06 00:00:00
33811 2 019596 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019596s051lbl.pdf
2012-03-29 00:00:00
33812 2 019614 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf
2010-04-04 00:00:00
33813 2 019625 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019625s024lbl.pdf
2013-04-23 00:00:00
33814 2 019626 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19626scs019_dextrose_lbl.p
df 2004-04-05 00:00:00
33815 2 019626 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019626s030lbl.pdf
2015-02-20 00:00:00
33816 2 019627 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf
2014-06-10 00:00:00
33817 2 019631 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19631s023lbl.pdf
2004-09-29 00:00:00
33818 2 019634 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019634s033lbl.pdf
2013-02-14 00:00:00
33819 14 019640 SUPPL 33 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33820 14 019640 SUPPL 47 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33821 14 019640 SUPPL 58 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33822 14 019640 SUPPL 92 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33823 2 019641 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
2003-03-20 00:00:00
33824 2 019641 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,0199
64s032lbl.pdf 2014-07-24 00:00:00
33825 2 019643 SUPPL 67 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s067lbl.pdf
2002-02-14 00:00:00
33826 2 019643 SUPPL 69 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s69lbl.pdf
2003-04-17 00:00:00
33827 2 019643 SUPPL 71 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s71lbl.pdf
2002-09-20 00:00:00
33828 2 019643 SUPPL 77 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s077lbl.pdf
2005-06-14 00:00:00
33829 2 019643 SUPPL 78 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s078lbl.pdf
2007-06-04 00:00:00
33830 2 019643 SUPPL 80 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf
2009-03-17 00:00:00
33831 2 019643 SUPPL 81 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019643s081lbl.pdf
2010-07-06 00:00:00
33832 2 019643 SUPPL 86 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf
2012-11-06 00:00:00
33833 2 019643 SUPPL 88 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019643s088lbl.pdf
2014-03-04 00:00:00
33834 2 019645 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s016lbl.pdf
2007-01-24 00:00:00
33835 2 019649 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.p
df 2007-03-15 00:00:00
33836 2 019649 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019649s014lbl.pdf
2009-01-21 00:00:00
33837 2 019650 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf
2001-04-11 00:00:00
33838 2 019651 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019651s020lbl.pdf
2009-10-06 00:00:00
33839 2 019655 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf
2001-03-30 00:00:00
33840 2 019655 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19
655slr038_retrovir_lbl.pdf 2003-04-04 00:00:00
33841 2 019655 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20
528slr011_retrovir_lbl.pdf 2003-10-17 00:00:00
33842 2 019655 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s043lbl.pdf
2006-11-16 00:00:00
33843 2 019655 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.p
df 2009-11-23 00:00:00
33844 2 019655 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,0205
18s023lbl.pdf 2012-06-06 00:00:00
33845 2 019655 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf
2015-01-08 00:00:00
33846 2 019658 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019658s026lbl.pdf
2013-09-18 00:00:00
33847 2 019667 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf
2005-09-08 00:00:00
33848 2 019667 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.p
df 2010-02-04 00:00:00
33849 2 019667 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf
2012-03-27 00:00:00
33850 2 019668 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf
2009-07-23 00:00:00
33851 14 019676 SUPPL 16 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33852 14 019676 SUPPL 20 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33853 14 019676 SUPPL 26 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33854 14 019676 SUPPL 30 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33855 14 019676 SUPPL 42 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33856 2 019678 SUPPL 5 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.p
df 2005-12-15 00:00:00
33857 2 019680 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019680s021lbl.pdf
2006-12-26 00:00:00
33858 2 019680 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf
2011-10-12 00:00:00
33859 2 019680 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf
2011-10-12 00:00:00
33860 2 019680 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s033lbl.pdf
2014-06-23 00:00:00
33861 2 019680 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s035lbl.pdf
2013-09-17 00:00:00
33862 2 019680 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s037lbl.pdf
2014-12-03 00:00:00
33863 2 019680 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s038lbl.pdf
2015-01-08 00:00:00
33864 2 019680 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s040lbl.pdf
2014-08-22 00:00:00
33865 2 019680 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.p
df 2015-03-17 00:00:00
33866 2 019680 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s042lbledt.pdf
2015-10-06 00:00:00
33867 2 019680 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s043lbl.pdf
2016-02-23 00:00:00
33868 2 019684 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019684s023lbl.pdf
2010-10-04 00:00:00
33869 2 019684 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019684s024lbl.pdf
2011-09-30 00:00:00
33870 2 019684 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019684s026lbl.pdf
2013-07-30 00:00:00
33871 2 019684 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019684s027lbl.pdf
2014-05-12 00:00:00
33872 2 019697 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.p
df 2007-05-07 00:00:00
33873 2 019697 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig
1s042lbl.pdf 2013-10-04 00:00:00
33874 2 019697 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,0216
90s001lbl.pdf 2015-05-04 00:00:00
33875 2 019699 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19699s013lbl.pdf
2004-09-29 00:00:00
33876 2 019700 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19700s019lbl.pdf
2002-02-08 00:00:00
33877 2 019700 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf
2005-03-11 00:00:00
33878 2 019715 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019715s027lbl.pdf
2009-08-13 00:00:00
33879 2 019716 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf
2005-10-14 00:00:00
33880 14 019717 SUPPL 54 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33881 14 019717 SUPPL 58 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33882 14 019717 SUPPL 94 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33883 14 019717 SUPPL 98 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33884 14 019717 SUPPL 99 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33885 14 019717 SUPPL 101 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33886 14 019717 SUPPL 133 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33887 14 019717 SUPPL 135 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33888 2 019726 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf
1998-07-27 00:00:00
33889 2 019726 SUPPL 52 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf
2009-09-17 00:00:00
33890 2 019726 SUPPL 57 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.p
df 2013-06-17 00:00:00
33891 2 019726 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.p
df 2014-10-09 00:00:00
33892 2 019732 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s
036,020517s024s028s029lbl.pdf 2010-05-07 00:00:00
33893 2 019732 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.p
df 2013-07-11 00:00:00
33894 2 019734 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019734s015lbl.pdf
2010-01-20 00:00:00
33895 2 019734 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019734s017lbl.pdf
2011-02-07 00:00:00
33896 2 019735 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735slr051_floxin_lbl.pdf
2004-04-05 00:00:00
33897 2 019735 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf
2004-09-17 00:00:00
33898 2 019735 SUPPL 53 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf
2004-09-17 00:00:00
33899 2 019735 SUPPL 55 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s055lbl.pdf
2006-06-20 00:00:00
33900 2 019735 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s057lbl.pdf
2007-06-27 00:00:00
33901 2 019735 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s058lbl.pdf
2007-12-14 00:00:00
33902 2 019735 SUPPL 59 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019735s059lbl.pdf
2008-10-09 00:00:00
33903 2 019735 SUPPL 61 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061lbl.pdf
2011-03-04 00:00:00
33904 2 019758 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758s45lbl.pdf
2002-01-14 00:00:00
33905 2 019758 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758se1-
047_Clozaril_lbl.pdf 2003-04-04 00:00:00
33906 2 019758 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s065lbl.pdf
2010-12-04 00:00:00
33907 2 019758 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
2013-03-26 00:00:00
33908 2 019758 SUPPL 69 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
2013-07-23 00:00:00
33909 2 019758 SUPPL 70 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
2013-03-26 00:00:00
33910 2 019758 SUPPL 71 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
2013-07-23 00:00:00
33911 2 019758 SUPPL 72 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s072lbl.pdf
2014-09-30 00:00:00
33912 2 019758 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s074lbl.pdf
2015-09-23 00:00:00
33913 2 019758 SUPPL 78 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s078lbl.pdf
2015-10-22 00:00:00
33914 2 019763 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019763s016lbl.pdf
2011-03-28 00:00:00
33915 2 019763 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019763s017lbl.pdf
2012-03-06 00:00:00
33916 2 019763 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019763s019lbl.pdf
2014-09-03 00:00:00
33917 14 019764 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33918 14 019764 SUPPL 25 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33919 14 019764 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33920 14 019764 SUPPL 49 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33921 14 019764 SUPPL 72 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33922 2 019766 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-
S040_Zocor_prntlbl.pdf 2000-04-27 00:00:00
33923 2 019766 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf
2002-05-06 00:00:00
33924 2 019766 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf
2002-03-21 00:00:00
33925 2 019766 SUPPL 56 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf
2002-10-18 00:00:00
33926 2 019766 SUPPL 70 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf
2005-05-20 00:00:00
33927 2 019766 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf
2007-06-04 00:00:00
33928 2 019766 SUPPL 77 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf
2011-06-08 00:00:00
33929 2 019766 SUPPL 81 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf
2010-11-04 00:00:00
33930 2 019766 SUPPL 82 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf
2011-06-08 00:00:00
33931 2 019766 SUPPL 83 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf
2011-10-12 00:00:00
33932 2 019766 SUPPL 87 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf
2012-11-02 00:00:00
33933 2 019771 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19771S20lbl.pdf
2003-06-10 00:00:00
33934 14 019774 SUPPL 14 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33935 14 019774 SUPPL 23 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33936 14 019774 SUPPL 26 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33937 14 019774 SUPPL 27 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33938 14 019774 SUPPL 28 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33939 2 019777 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-
044,slr042_zestril_lbl.pdf 2003-07-08 00:00:00
33940 2 019777 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-
044,slr042_zestril_lbl.pdf 2004-01-02 00:00:00
33941 2 019777 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s057lbl.pdf
2014-06-30 00:00:00
33942 2 019777 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019777s058lbl.pdf
2011-08-12 00:00:00
33943 2 019777 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s062lbl.pdf
2012-08-15 00:00:00
33944 2 019777 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019777s074lbl.pdf
2016-04-29 00:00:00
33945 2 019778 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_prntlbl.pdf
1998-10-28 00:00:00
33946 2 019778 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778Orig1s046_REPLACEMEN
T.pdf 2011-11-21 00:00:00
33947 2 019778 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s047lbl.pdf
2011-08-30 00:00:00
33948 2 019778 SUPPL 48 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019778s048lbl.pdf
2012-06-11 00:00:00
33949 2 019779 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf
2004-12-30 00:00:00
33950 2 019781 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf
2009-07-06 00:00:00
33951 2 019787 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s037lbl.pdf
2005-07-15 00:00:00
33952 2 019787 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf
2005-09-30 00:00:00
33953 2 019787 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019787s045lbl.pdf
2010-02-23 00:00:00
33954 2 019787 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s047lbl.pdf
2011-05-09 00:00:00
33955 2 019790 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdf
2014-11-18 00:00:00
33956 2 019796 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf
2002-07-17 00:00:00
33957 2 019796 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019796s020lbl.pdf
2005-09-15 00:00:00
33958 2 019805 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf
2014-03-19 00:00:00
33959 2 019807 SUPPL 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s001lbl.pdf
2011-03-28 00:00:00
33960 2 019810 SUPPL 3 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-
058,slr003_prilosec_lbl.pdf 2004-04-05 00:00:00
33961 2 019810 SUPPL 58 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-
058,slr003_prilosec_lbl.pdf 2004-04-05 00:00:00
33962 2 019810 SUPPL 67 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_l
bl.pdf 2003-10-16 00:00:00
33963 2 019810 SUPPL 74 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19810s074lbl.pdf
2002-07-12 00:00:00
33964 2 019810 SUPPL 80 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_l
bl.pdf 2003-10-16 00:00:00
33965 2 019810 SUPPL 82 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19810s082lbl.pdf
2005-03-10 00:00:00
33966 2 019810 SUPPL 83 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s083lbl.pdf
2006-01-27 00:00:00
33967 2 019810 SUPPL 84 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s084lbl.pdf
2006-09-26 00:00:00
33968 2 019810 SUPPL 88 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.p
df 2010-03-05 00:00:00
33969 2 019810 SUPPL 90 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.p
df 2010-09-10 00:00:00
33970 2 019810 SUPPL 94 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbled
t.pdf 2012-02-06 00:00:00
33971 2 019810 SUPPL 95 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.p
df 2012-10-12 00:00:00
33972 2 019810 SUPPL 98 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.p
df 2014-04-01 00:00:00
33973 2 019810 SUPPL 99 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.p
df 2014-02-27 00:00:00
33974 2 019813 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019813s033lbl.pdf
2008-02-14 00:00:00
33975 2 019813 SUPPL 36 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19813se1-
036_duragesic_lbl.pdf 2003-06-08 00:00:00
33976 2 019813 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19813s039lbl.pdf
2005-02-08 00:00:00
33977 2 019813 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019813s044lblnew.pdf
2010-04-01 00:00:00
33978 2 019813 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019813s052lbl.pdf
2012-07-12 00:00:00
33979 2 019813 SUPPL 63 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019813s063lbl.pdf
2014-04-16 00:00:00
33980 2 019814 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814S11lbl.pdf
2003-06-10 00:00:00
33982 2 019816 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019816s011lbl.pdf
2007-08-02 00:00:00
33983 14 019818 SUPPL 34 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
33984 2 019821 SUPPL 6 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf
2003-04-28 00:00:00
33985 2 019821 SUPPL 10 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821scp010_soriatane_lbl.
pdf 2004-04-05 00:00:00
33986 2 019821 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821s011lbl.pdf
2004-10-15 00:00:00
33987 2 019821 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf
2007-10-22 00:00:00
33988 2 019821 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018lbl.pdf
2011-11-29 00:00:00
33989 2 019821 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s023lbl.pdf
2014-01-31 00:00:00
33990 2 019822 SUPPL 6 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19822slr006_Pre-
Scrub_lbl.pdf 2003-01-09 00:00:00
33991 2 019824 SUPPL 8 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf
2003-03-28 00:00:00
33992 2 019824 SUPPL 23 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,0205
19s016lbl.pdf 2013-07-11 00:00:00
33993 2 019826 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019826s023lbl.pdf
2012-02-22 00:00:00
33994 2 019828 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_ox
istat_lbl.pdf 2004-02-02 00:00:00
33995 2 019829 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf
2013-08-05 00:00:00
33996 2 019830 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019830s018lbl.pdf
2013-02-06 00:00:00
33997 2 019832 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19832lbl.pdf 1998-
06-05 00:00:00
33998 2 019834 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf
2012-11-02 00:00:00
33999 2 019835 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf
2002-10-21 00:00:00
34000 2 019835 SUPPL 16 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30
346slr011_zyrtec_lbl.pdf 2004-04-05 00:00:00
34001 2 019839 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf
2003-04-25 00:00:00
34002 2 019839 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-
839S035_Zoloft_Prntlbl.pdf 2001-08-17 00:00:00
34003 2 019839 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf
2002-05-16 00:00:00
34004 2 019839 SUPPL 47 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,01
7lbl.pdf 2004-08-25 00:00:00
34005 2 019839 SUPPL 54 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf
2005-07-14 00:00:00
34006 2 019839 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s
026lbl.pdf 2006-09-15 00:00:00
34007 2 019839 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027l
bl.pdf 2007-08-03 00:00:00
34008 2 019839 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027l
bl.pdf 2007-08-03 00:00:00
34009 2 019839 SUPPL 65 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.p
df 2007-10-10 00:00:00
34010 2 019839 SUPPL 72 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s
033s036s037lbl.pdf 2011-08-24 00:00:00
34011 2 019839 SUPPL 73 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s0
40lbl.pdf 2012-12-28 00:00:00
34012 2 019839 SUPPL 79 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.p
df 2013-02-06 00:00:00
34013 2 019839 SUPPL 81 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s0
40lbl.pdf 2012-12-28 00:00:00
34014 2 019842 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf
2007-09-11 00:00:00
34015 2 019845 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019845s020lbl.pdf
2007-06-12 00:00:00
34016 2 019847 SUPPL 24 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf
2000-08-30 00:00:00
34017 2 019847 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf
2002-04-17 00:00:00
34018 2 019847 SUPPL 28 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s03
3,034,036lbl.pdf 2004-07-21 00:00:00
34019 2 019847 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s03
3,034,036lbl.pdf 2004-07-21 00:00:00
34020 2 019847 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.p
df 2005-05-20 00:00:00
34021 2 019847 SUPPL 39 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019847s39lbl.pdf
2007-06-27 00:00:00
34022 2 019847 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.p
df 2008-01-23 00:00:00
34023 2 019847 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s4
9,20780s26,21473s24lbl.pdf 2008-10-09 00:00:00
34024 2 019847 SUPPL 44 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s7019847441985751207
80282147325L.pdf 2009-05-11 00:00:00
34025 2 019847 SUPPL 46 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.p
df 2011-11-16 00:00:00
34026 2 019847 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.p
df 2013-02-01 00:00:00
34027 2 019847 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s054lbl.pdf
2013-08-15 00:00:00
34028 2 019847 SUPPL 57 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019847s057lbl.pdf
2016-07-26 00:00:00
34029 2 019851 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019851s038lbl.pdf
2009-11-16 00:00:00
34030 2 019851 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf
2012-05-22 00:00:00
34031 2 019851 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s043lbl.pdf
2012-01-23 00:00:00
34032 2 019851 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s044lbl.pdf
2012-09-25 00:00:00
34033 2 019851 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019851s046lbl.pdf
2014-12-16 00:00:00
34034 2 019851 SUPPL 47 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s047lbl.pdf
2015-01-30 00:00:00
34035 2 019851 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf
2015-07-24 00:00:00
34036 2 019853 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.
pdf 2003-06-08 00:00:00
34037 2 019856 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf
2014-07-22 00:00:00
34038 2 019856 SUPPL 24 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf
2014-07-22 00:00:00
34039 2 019856 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019856s027lbl.pdf
2011-02-04 00:00:00
34040 2 019857 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf
2002-04-17 00:00:00
34041 2 019857 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s03
3,034,036lbl.pdf 2004-07-21 00:00:00
34042 2 019857 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s
035,20780s016lbl.pdf 2005-01-11 00:00:00
34043 2 019857 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.p
df 2005-05-20 00:00:00
34044 2 019857 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857
s41,020780s20,021473s13lbl.pdf 2005-11-17 00:00:00
34045 2 019857 SUPPL 48 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.p
df 2008-01-23 00:00:00
34046 2 019857 SUPPL 49 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s4
9,20780s26,21473s24lbl.pdf 2008-10-09 00:00:00
34047 2 019857 SUPPL 51 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s7019847441985751207
80282147325L.pdf 2009-05-11 00:00:00
34048 2 019857 SUPPL 53 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.p
df 2011-11-16 00:00:00
34049 2 019857 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,0198
57s058,020780s037,021473s032MedG.pdf 2011-08-12 00:00:00
34050 2 019857 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.p
df 2013-02-01 00:00:00
34051 2 019857 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.p
df 2015-03-02 00:00:00
34052 2 019857 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.p
df 2015-03-20 00:00:00
34053 2 019858 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf
2002-04-17 00:00:00
34054 2 019862 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/in111med042403LB.pdf
2004-03-16 00:00:00
34055 2 019865 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf
2011-02-04 00:00:00
34056 2 019865 SUPPL 20 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf
2011-08-24 00:00:00
34057 2 019872 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pd
f 2003-06-08 00:00:00
34058 2 019872 SUPPL 14 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pd
f 2003-06-08 00:00:00
34059 2 019872 SUPPL 36 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019872Orig1s036lbl.pdf
2014-01-09 00:00:00
34060 2 019872 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s037lbl.pdf
2014-01-09 00:00:00
34061 2 019872 SUPPL 42 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s042lbl.pdf
2015-01-05 00:00:00
34062 2 019881 SUPPL 9 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19881slr009_gynazole_lbl.p
df 2003-08-06 00:00:00
34063 2 019885 SUPPL 35 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf
2012-01-23 00:00:00
34064 2 019885 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf
2013-04-16 00:00:00
34065 2 019885 SUPPL 40 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf
2014-05-06 00:00:00
34066 2 019886 SUPPL 22 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019886s022lbl.pdf
2006-04-13 00:00:00
34067 2 019886 SUPPL 27 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
2011-01-11 00:00:00
34068 2 019886 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf
2012-01-12 00:00:00
34069 2 019887 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019887s014lbl.pdf
2011-02-09 00:00:00
34070 2 019888 SUPPL 45 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s045lbl.pdf
2009-05-25 00:00:00
34071 2 019888 SUPPL 49 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s049lbl.pdf
2011-03-11 00:00:00
34072 2 019888 SUPPL 50 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s050lbl.pdf
2011-08-05 00:00:00
34073 2 019888 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s051lbl.pdf
2012-05-07 00:00:00
34074 2 019888 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s052lbl.pdf
2012-03-29 00:00:00
34075 2 019888 SUPPL 54 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s054lbl.pdf
2012-08-15 00:00:00
34076 2 019890 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19890s17lbl.pdf
2002-01-14 00:00:00
34077 2 019898 SUPPL 42 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s42lbl.pdf
2001-06-15 00:00:00
34078 2 019898 SUPPL 46 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s46lbl.pdf
2001-12-18 00:00:00
34079 2 019898 SUPPL 52 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s052lbl.pdf
2002-10-29 00:00:00
34080 2 019898 SUPPL 63 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf
2012-11-06 00:00:00
34081 2 019898 SUPPL 64 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf
2012-11-06 00:00:00
34082 2 019899 SUPPL 15 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf
2003-08-06 00:00:00
34083 2 019901 SUPPL 60 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s060lbl.pdf
2013-09-23 00:00:00
34084 2 019901 SUPPL 62 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s062lbl.pdf
2013-11-04 00:00:00
34085 2 019901 SUPPL 64 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019901s064lbl.pdf
2014-05-06 00:00:00
34086 2 019901 SUPPL 65 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019901s065lbl.pdf
2015-09-14 00:00:00
34087 2 019906 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19906s9lbl.pdf
2003-06-10 00:00:00
34088 2 019908 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf
2010-04-19 00:00:00
34089 2 019908 SUPPL 34 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s
015lbl.pdf 2013-04-23 00:00:00
34090 2 019908 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.p
df 2014-10-09 00:00:00
34091 2 019909 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19909s16s17lbl.pdf
2003-06-10 00:00:00
34092 2 019909 SUPPL 20 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,0199
09s020lbl.pdf 2005-12-15 00:00:00
34093 2 019910 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf
2001-03-30 00:00:00
34094 2 019910 SUPPL 26 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19
655slr038_retrovir_lbl.pdf 2003-04-04 00:00:00
34095 2 019910 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033lbl.pdf
2008-09-23 00:00:00
34096 2 019910 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,0205
18s022lbl.pdf 2011-11-25 00:00:00
34097 2 019910 SUPPL 40 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,0205
18s023lbl.pdf 2012-06-06 00:00:00
34098 2 019910 SUPPL 41 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf
2015-01-08 00:00:00
34099 2 019915 SUPPL 37 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19915se5-
037_monopril_lbl.pdf 2003-06-08 00:00:00
34100 2 019922 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-
005_colopam_lbl.pdf 2004-04-05 00:00:00
34101 2 019922 SUPPL 16 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf
2015-12-18 00:00:00
34102 2 019927 SUPPL 28 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019927s028lbl.pdf
2009-09-17 00:00:00
34103 2 019931 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019931s019lbl.pdf
2010-07-06 00:00:00
34104 14 019938 SUPPL 32 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34105 14 019938 SUPPL 37 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34106 14 019938 SUPPL 63 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34107 14 019938 SUPPL 64 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34108 14 019938 SUPPL 66 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34109 2 019941 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941S11LBL.PDF
2000-01-28 00:00:00
34110 2 019941 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019941s017lbl.pdf
2006-01-05 00:00:00
34111 2 019943 SUPPL 29 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.p
df 2009-06-04 00:00:00
34112 2 019943 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,0207
08s031lbl.pdf 2012-03-28 00:00:00
34113 2 019943 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.p
df 2011-06-16 00:00:00
34114 2 019943 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s033lbl.pdf
2012-01-23 00:00:00
34115 2 019943 SUPPL 34 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019943s034lbl.pdf
2013-11-05 00:00:00
34116 2 019946 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019946s007lbl.pdf
2010-11-22 00:00:00
34117 2 019949 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33
,37,20090s12,14,17lbl.pdf 2004-10-08 00:00:00
34118 2 019949 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33
,37,20090s12,14,17lbl.pdf 2004-10-08 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf
2002-08-07 00:00:00
34120 2 019949 SUPPL 35 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33
,37,20090s12,14,17lbl.pdf 2004-10-08 00:00:00
34121 2 019949 SUPPL 41 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,0200
90s022lbl.pdf 2008-04-16 00:00:00
34122 2 019949 SUPPL 51 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s051lbl.pdf
2011-06-06 00:00:00
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,0200
90s038lbl.pdf 2011-11-21 00:00:00
34124 2 019949 SUPPL 60 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.p
df 2014-11-04 00:00:00
34125 2 019950 SUPPL 31 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33
,37,20090s12,14,17lbl.pdf 2004-10-08 00:00:00
34126 2 019950 SUPPL 33 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33
,37,20090s12,14,17lbl.pdf 2004-10-08 00:00:00
34127 2 019950 SUPPL 43 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,0200
90s022lbl.pdf 2008-04-16 00:00:00
34128 2 019950 SUPPL 59 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,0200
90s038lbl.pdf 2011-11-21 00:00:00
34129 2 019950 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,0200
90s040lbl.pdf 2013-09-17 00:00:00
34130 2 019950 SUPPL 62 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,0200
90s042lbl.pdf 2014-03-25 00:00:00
34131 2 019951 SUPPL 19 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr019_retrovir_lbl.p
df 2003-08-14 00:00:00
34132 2 019951 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019951s023lbl.pdf
2006-07-13 00:00:00
34133 2 019951 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019951s029lbl.pdf
2011-11-25 00:00:00
34134 2 019951 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019951s030lbl.pdf
2012-06-06 00:00:00
34135 2 019952 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019952s021lbl.pdf
2009-03-17 00:00:00
34136 2 019952 SUPPL 26 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019952s026lbl.pdf
2011-12-23 00:00:00
34137 2 019952 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s030lbl.pdf
2013-01-11 00:00:00
34138 2 019952 SUPPL 31 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s031lbl.pdf
2013-09-09 00:00:00
34139 2 019953 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf
2009-03-17 00:00:00
34140 2 019953 SUPPL 25 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf
2011-12-23 00:00:00
34141 2 019953 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf
2013-01-11 00:00:00
34142 2 019953 SUPPL 30 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf
2013-09-09 00:00:00
34143 2 019955 SUPPL 13 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,0199
55s013lbl.pdf 2007-11-07 00:00:00
34144 2 019957 SUPPL 9 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
2003-06-10 00:00:00
34145 2 019957 SUPPL 12 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf
2015-02-20 00:00:00
34146 2 019958 SUPPL 8 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf
1999-06-17 00:00:00
34147 2 019958 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf
1999-06-17 00:00:00
34148 2 019958 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf
2002-04-16 00:00:00
34149 2 019958 SUPPL 17 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf
2010-09-07 00:00:00
34150 14 019959 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34151 14 019959 SUPPL 36 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34152 14 019959 SUPPL 66 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34153 14 019959 SUPPL 75 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34154 2 019962 SUPPL 27 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19962s027lbl.pdf
2005-02-17 00:00:00
34155 2 019962 SUPPL 32 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf
2006-08-04 00:00:00
34156 2 019962 SUPPL 33 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019962s033lbl.pdf
2007-07-24 00:00:00
34157 2 019962 SUPPL 38 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019962s038lbl.pdf
2009-03-02 00:00:00
34158 2 019962 SUPPL 43 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019962s43lbl.pdf
2012-11-02 00:00:00
34159 2 019962 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019962s044lbl.pdf
2014-05-12 00:00:00
34160 2 019963 SUPPL 5 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF
2000-08-01 00:00:00
34161 2 019963 SUPPL 7 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF
2000-08-01 00:00:00
34162 2 019964 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
2003-03-20 00:00:00
34163 2 019964 SUPPL 30 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,0199
64s030lbl.pdf 2013-09-27 00:00:00
34164 2 019964 SUPPL 32 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,0199
64s032lbl.pdf 2014-07-24 00:00:00
34165 2 019967 SUPPL 4 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019967s004lbl.pdf
2003-04-07 00:00:00
34166 2 019967 SUPPL 10 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19967s010lbl.pdf
2004-09-17 00:00:00
34167 2 019967 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019967s015lbl.pdf
2012-04-02 00:00:00
34168 2 019968 SUPPL 11 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf
2012-04-02 00:00:00
34169 2 019970 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019970s015lbl.pdf
2014-10-03 00:00:00
34170 2 019979 SUPPL 18 0
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-
979S018_Ticlid_prntlbl.pdf 2001-04-18 00:00:00
34171 2 019982 SUPPL 14 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019982s014lbl.pdf
2010-08-12 00:00:00
34172 14 019991 SUPPL 31 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34173 14 019991 SUPPL 32 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34174 14 019991 SUPPL 68 This Former NDA Was Deemed To Be a BLA on
March 23, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
event=faq.page#nda_bla 2020-03-23 00:00:00
34175 2 019992 SUPPL 19 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf
2004-08-25 00:00:00
34176 2 019998 SUPPL 13 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf
2007-07-16 00:00:00
34177 2 020007 SUPPL 39 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.p
df 2006-08-23 00:00:00
34178 2 020007 SUPPL 44 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020007s044lbl.pdf
2013-12-11 00:00:00
34179 2 020010 ORIG 1 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20010lbl.pdf 2000-
12-08 00:00:00
34180 2 020010 SUPPL 21 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020010s021lbl.pdf
2009-05-13 00:00:00
34181 2 020011 SUPPL 37 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.p
df 2010-10-29 00:00:00
34182 2 020011 SUPPL 38 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,0207
08s031lbl.pdf 2012-03-28 00:00:00
34183 2 020013 SUPPL 15 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf
2005-03-18 00:00:00
34184 2 020031 SUPPL 23 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s23lbl.pdf
2003-04-24 00:00:00
34185 2 020031 SUPPL 29 0
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s29lbl.pdf
2001-12-14 00:00:00
34186 2 020031 SUPPL 58 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s
030lbl.pdf 2011-07-12 00:00:00
34187 2 020031 SUPPL 61 0

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.p
df 2009-02-04 00:00:00
34188 2 020031 SUPPL

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