FAMOTIDINE | N019462 | BAUSCH HEALTH US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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reducer, seeking confirmation that the product meets the criteria for OTC marketing author | Suitability | 2023-11-15 | Withdrawn | Tenshi Kaizen Private Limited |
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2021-P-0885 · 6 docket documents Zydus Pharmaceuticals (USA) Inc. filed this petition requesting that the FDA determine whether the Reference Listed Drug PEPCID (famotidine) tablets at 20 mg and 40 mg strengths, NDA Number N019462 held by Valeant Pharmaceuticals North America LLC, was voluntarily withdrawn from commercial sale for | 505(q) | 2021-08-12 | Granted | Zydus Pharmaceuticals (USA) Inc. |
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Strips 10 mg suitable for submission as an ANDA with Pepcid ACS Chewable Tablets 10 mg (ap | Suitability | 2008-04-14 | Withdrawn | Olsson, Frank And Weeda, P. C. - Enclosure C - Docket 2004P-0353 (FDA let & ANDA suitability petition) |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.
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