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Attachment 1 - Copies of relevant pages of Orange Book 45th Edition Cumulative Supplement 10, October 2025 (The eRulemaking Program)

Public Technologies 15 Dec 2025
). RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2025 1 -132. TECHNETIUM TC-99M PENTETATE KIT. INJECTABLE;INJECTION DRAXIMAGE DTPA. AP. +! JUBILANT N/A TECHNETIUM TC-99M PENTETATE KIT. N 018511. 001. Dec 29, 1989. Mar CFTG. AP. CURIUM N/A. A 215146.
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Attachment 2 - Copies of relevant pages of current Orange Book for approved generic applications of Telmisartan Tablets, 20 mg and 80 mg. (The eRulemaking Program)

Public Technologies 15 Dec 2025
). Mkt.Status. Active Ingredient. Proprietary Name. Appl. No. Product Number. Dosage Form. Route. Strength. TE Code. RLD. RS. Applicant Holder. Approval Date. RX. TELMISARTAN. MICARDIS. N020850. 1. TABLET. ORAL. 40MG. AB. RLD. BOEHRINGER INGELHEIM. 10-Nov-98. RX. TELMISARTAN ... 1.
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Attachment 1 - Copy of the relevant excerpt from the current electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (The eRulemaking Program)

Public Technologies 10 Dec 2025
). Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. Mkt.Status. Active Ingredient. Proprietary Name. Appl. No. Dosage Form.
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Attachment 1 - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - Product Details for ANDA 086833 (The eRulemaking Program)

Public Technologies 09 Dec 2025
). ◻ Menu. ◻ Search. An official website of the United States government Here's how you know ◻. ◻ Home / Drug Databases / Orange Book Home. ◻ Share Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. ◻ Tweet. ◻ Linkedin. ◻ Email ... Yes.
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ISN releases 2025 edition of "The Orange Book"

Telegraph Herald 04 Dec 2025
DALLAS — ISN, a global leader in contractor and supplier information management services, has announced the release of its latest edition of “The Orange Book. The Journey to Best-in-Class Contractor Management.” ... .
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Attachment 1 - Orange Book (The eRulemaking Program)

Public Technologies 22 Nov 2025
). ‌Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. Mkt.Status. Active Ingredient. Proprietary Name. Appl. No. Dosage Form. Route. Strength. TE. Code. RLD. RS ... Drug Databases (https.//www.fda.gov/Drugs/InformationOnDrugs/) Orange Book.
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ISN� Releases 2025 Edition of The Orange Book

Business Wire 20 Nov 2025
... of its latest edition of The Orange Book, The Journey to Best-in-Class Contractor Management.
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ISN® Releases 2025 Edition of The Orange Book

The Galveston Daily News 19 Nov 2025
DALLAS--(BUSINESS WIRE)--Nov 19, 2025-- ....
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Reference 40 - FDA Orange book “Indomethacin” (The eRulemaking Program)

Public Technologies 14 Nov 2025
). Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. Mkt.Status. Active. Ingredient. Proprietary Appl. Dosage Name No. Form. Route Strength. TE Code. RLD RS Applicant Holder. RX. INDOMETHACIN. INDOMETHACIN. A215399. SUPPOSITORY. RECTAL ... AB.
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Attachment 1 Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations (1) (The eRulemaking Program)

Public Technologies 12 Nov 2025
). Orange Book. Approved Drug Products with Therapeutic. Equivalence Evaluations. Mkt.Status. Active Ingredient. Proprietary Name. Appl. No.
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Exhibit 9 - FDA Orange Book Patent and Exclusivity Info for N021539 (The eRulemaking Program)

Public Technologies 12 Nov 2025
) ... / Orange Book Home (index.cfm) Orange Book ... Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner ... 001 ... DP.
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Exhibit 10 - FDA Orange Book Cumulative Supplement 9 - 45th Edition Sept. 2025 (The eRulemaking Program)

Public Technologies 12 Nov 2025
). Exhibit 10 ‌CUMULATIVE SUPPLEMENT 9. September 2025. APPROVED DRUG PRODUCTS. WITH. THERAPEUTIC EQUIVALENCE EVALUATIONS 45th EDITION. Department of Health and Human Services ... Office of Generic Drugs Office of Generic Drug Policy. 2025. A - 2 ... APPL/PROD ... NO ... Y.
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Attachment 1 - Orange Book Listing for Clarinex Tablets (The eRulemaking Program)

Public Technologies 24 Oct 2025
). ‌Attachment 1. Drug Databases (https.//www.fda.gov/Drugs/InformationOnDrugs/). Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. Home (index.cfm?resetfields=1) ... Active Ingredient. DESLORATADINE. Proprietary Name. CLARINEX ... 5MG.
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Attachment 1 Orange Book Zanaflex (The eRulemaking Program)

Public Technologies 20 Oct 2025
). / Orange Book Home (index.cfm ). Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. Home (index.cfm?resetfields=1) . Back to Search Results Product Details for NDA 020397. Collapse All ... Marketing Status. Prescription ... ZANAFLEX.
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Attachment 1 - Orange Book - Approved Drug Products with Therapeutic Equivalence - CYTOMEL (The eRulemaking Program)

Public Technologies 20 Oct 2025
). ‌Attachment 1. Drug Databases (https.//www.fda.gov/Drugs/InformationOnDrugs/) Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. Home (index.cfm?resetfields=1) . Back to Search Results Product Details for NDA 010379 ... CYTOMEL.

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