PEPCID

FDA-2023-P-5042

Tenshi Kaizen Private Limited filed a petition regarding famotidine orally disintegrating tablets 20 mg, requesting a determination of regulatory eligibility or suitability for this product formulation.

FDA-2023-P-5042

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-2023-P-5042

Tenshi Kaizen Private Limited filed a petition regarding Maximum Strength Pepcid AC Famotidine Tablets 20mg, an acid reducer product, requesting a determination of regulatory eligibility or suitability status for the formulation.

FDA-2023-P-5042

Tenshi Kaizen Private Limited filed a petition requesting that the FDA establish a reference standard (RE suitability) for famotidine orally disintegrating tablets at the 10 mg strength to enable the company to develop and submit an ANDA for this pharmaceutical product.

FDA-2021-P-1111

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whether PEPCID (famotidine) suspension 40mg/5mL, NDA Number N019527 held by Salix Pharmaceuticals Inc, was voluntarily withdrawn from the commercial market for safety or efficacy reasons, or for commercial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

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PEPCID (famotidine) for Suspension, 40 mg/5 mL, NDA Number 019527, held by Salix Pharmaceuticals Inc., was voluntarily withdrawn from the market for safety or effectiveness reasons.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

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