Mkt.

Status Active Ingredient

RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX BACLOFEN
RX CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASS
RX INDIUM IN-111 PENTETATE DISODIUM
RX NUSINERSEN SODIUM
RX TOFERSEN
RX ZICONOTIDE ACETATE
RX ZICONOTIDE ACETATE
RX ZICONOTIDE ACETATE
DISCN BACLOFEN
DISCN BACLOFEN
DISCN CHLOROPROCAINE HYDROCHLORIDE
DISCN GENTAMICIN SULFATE
DISCN IOTROLAN
DISCN IOTROLAN
DISCN ZICONOTIDE ACETATE
 Orange Book: Approved Drug Products with Therap
Proprietary Name Appl. No. Product Number Dosage Form Route
BACLOFEN A091193 001 INJECTABLE INTRATHECAL
BACLOFEN A210777 001 INJECTABLE INTRATHECAL
BACLOFEN A091193 002 INJECTABLE INTRATHECAL
BACLOFEN A210048 001 INJECTABLE INTRATHECAL
BACLOFEN A209592 001 INJECTABLE INTRATHECAL
BACLOFEN A217324 001 INJECTABLE INTRATHECAL
BACLOFEN A210315 001 INJECTABLE INTRATHECAL
BACLOFEN A209594 001 INJECTABLE INTRATHECAL
BACLOFEN A217324 002 INJECTABLE INTRATHECAL
BACLOFEN A091193 003 INJECTABLE INTRATHECAL
BACLOFEN A210048 002 INJECTABLE INTRATHECAL
BACLOFEN A209592 002 INJECTABLE INTRATHECAL
BACLOFEN A217324 003 INJECTABLE INTRATHECAL
GABLOFEN N022462 001 INJECTABLE INTRATHECAL
GABLOFEN N022462 002 INJECTABLE INTRATHECAL
GABLOFEN N022462 004 INJECTABLE INTRATHECAL
GABLOFEN N022462 003 INJECTABLE INTRATHECAL
LIORESAL N020075 003 INJECTABLE INTRATHECAL
LIORESAL N020075 001 INJECTABLE INTRATHECAL
LIORESAL N020075 002 INJECTABLE INTRATHECAL
ELLIOTTS B SOLUTION N020577 001 INJECTABLE INTRATHECAL
MPI INDIUM DTPA IN 111 N017707 001 INJECTABLE INTRATHECAL
SPINRAZA N209531 001 SOLUTION INTRATHECAL
QALSODY N215887 001 SOLUTION INTRATHECAL
PRIALT N021060 002 INJECTABLE INTRATHECAL
PRIALT N021060 001 INJECTABLE INTRATHECAL
PRIALT N021060 004 INJECTABLE INTRATHECAL
BACLOFEN A216309 001 INJECTABLE INTRATHECAL
BACLOFEN A216309 002 INJECTABLE INTRATHECAL
CLOROTEKAL N208791 001 SOLUTION INTRATHECAL
GARAMYCIN N050505 001 INJECTABLE INTRATHECAL
OSMOVIST 190 N019580 001 INJECTABLE INTRATHECAL
OSMOVIST 240 N019580 002 INJECTABLE INTRATHECAL
PRIALT N021060 003 INJECTABLE INTRATHECAL
ed Drug Products with Therapeutic Equivalence Evaluations
Strength TE Code RLD RS
0.05MG/ML AP
0.05MG/ML AP
0.5MG/ML AP
0.5MG/ML AP
0.5MG/ML AP
0.5MG/ML AP
1MG/ML AP
1MG/ML AP
1MG/ML AP
2MG/ML AP
2MG/ML AP
2MG/ML AP
2MG/ML AP
0.05MG/ML AP RLD RS
0.5MG/ML AP RLD RS
1MG/ML AP RLD RS
2MG/ML AP RLD RS
0.05MG/ML AP RLD RS
0.5MG/ML AP RLD RS
2MG/ML AP RLD RS
0.2MG/ML; 0.8MG/ML; 0.3MG/ML; 0.3MG/ML; 1.9MG/ML; 7.3MG/ML; 0. RLD RS
1mCi/ML RLD RS
EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) RLD RS
100MG/15ML (6.7MG/ML) RLD RS
100MCG/1ML (100MCG/ML) RLD RS
500MCG/20ML (25MCG/ML) RLD RS
500MCG/5ML (100MCG/ML) RLD RS
0.5MG/ML
2MG/ML
50MG/5ML (10MG/ML) RLD
EQ 2MG BASE/ML **Federal Register determination that product was not dis
RLD
40.6%
51.3%
200MCG/2ML (100MCG/ML)
Applicant Holder Approval Date
AMNEAL PHARMACEUTICALS LLC May 3, 2016
MAIA PHARMACEUTICALS INC Jan 15, 2021
AMNEAL PHARMACEUTICALS LLC May 3, 2016
MAIA PHARMACEUTICALS INC Sep 11, 2019
NORVIUM BIOSCIENCE LLC Mar 21, 2018
RUBICON RESEARCH PRIVATE LTD Feb 22, 2023
MAIA PHARMACEUTICALS INC Jul 30, 2019
NORVIUM BIOSCIENCE LLC Mar 6, 2018
RUBICON RESEARCH PRIVATE LTD Feb 22, 2023
AMNEAL PHARMACEUTICALS LLC May 3, 2016
MAIA PHARMACEUTICALS INC Sep 11, 2019
NORVIUM BIOSCIENCE LLC Mar 21, 2018
RUBICON RESEARCH PRIVATE LTD Feb 22, 2023
PIRAMAL CRITICAL CARE INC Nov 19, 2010
PIRAMAL CRITICAL CARE INC Nov 19, 2010
PIRAMAL CRITICAL CARE INC Jun 22, 2012
PIRAMAL CRITICAL CARE INC Nov 19, 2010
AMNEAL PHARMACEUTICALS LLC Nov 7, 1996
AMNEAL PHARMACEUTICALS LLC Jun 17, 1992
AMNEAL PHARMACEUTICALS LLC Jun 17, 1992
LUKARE MEDICAL LLC Sep 27, 1996
GE HEALTHCARE Feb 18, 1982
BIOGEN IDEC INC Dec 23, 2016
BIOGEN MA INC Apr 25, 2023
TERSERA THERAPEUTICS LLC Dec 28, 2004
TERSERA THERAPEUTICS LLC Dec 28, 2004
TERSERA THERAPEUTICS LLC Dec 28, 2004
HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS
Aug 10, 2023
HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS
Aug 10, 2023
B BRAUN MEDICAL INC Sep 26, 2017
SCHERING CORP SUB SCHERING PLOUGH CORP Approved Prior to Jan 1, 1982
BAYER HEALTHCARE PHARMACEUTICALS INC Dec 7, 1989
BAYER HEALTHCARE PHARMACEUTICALS INC Dec 7, 1989
TERSERA THERAPEUTICS LLC Dec 28, 2004