PEPCID

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

FDA-2021-P-1111 · 4 docket documents

Lachman Consultant Services Inc filed this citizen petition requesting that the FDA determine whether PEPCID (famotidine) suspension 40mg/5mL, NDA Number N019527 held by Salix Pharmaceuticals Inc, was voluntarily withdrawn from the commercial market for safety or efficacy reasons, or for commercial

FDA-2021-P-1097 · 4 docket documents

Ajanta Pharma Limited filed this petition requesting that the FDA determine whether PEPCID (famotidine) for Suspension, 40 mg/5 mL, NDA Number 019527, held by Salix Pharmaceuticals Inc., was voluntarily withdrawn from the market for safety or effectiveness reasons. The petitioner seeks this determin

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