FAMOTIDINE | N019510 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sagent Pharmaceuticals FDA-2026-P-1791 · 2 docket documents Sagent Pharmaceuticals submitted a citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA assign a therapeutic equivalence rating, specifically an "AP" code, to NDA 219935 Famotidine Injection (available in 4 mg/mL concentrations in single-dose and multi-dose vials) in the Orange B | 505(q) | 2026-02-19 | Open | Sagent Pharmaceuticals |
Attachment 2 - Original Strength Pepcid AC Famotidine Tablets 10mg Acid Reduc... FDA-2023-P-5042 · 10 docket documents Tenshi Kaizen Private Limited filed a petition requesting FDA evaluation of the regulatory eligibility and suitability of Original Strength Pepcid AC Famotidine Tablets 10mg for over-the-counter use as an acid reducer, seeking confirmation that the product meets the criteria for OTC marketing author | Suitability | 2023-11-15 | Withdrawn | Tenshi Kaizen Private Limited |
Background Material re Citizen Petition from Olsson, Frank And Weeda, P. C. -... FDA-2007-P-0059 · 5 docket documents Lachman Consultant Services, Inc. filed a citizen petition on August 4, 2004, under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Famotidine Orally Dissolving Strips 10 mg suitable for submission as an ANDA with Pepcid ACS Chewable Tablets 10 mg (ap | Suitability | 2008-04-14 | Withdrawn | Olsson, Frank And Weeda, P. C. - Enclosure C - Docket 2004P-0353 (FDA let & ANDA suitability petition) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.