PEPCID

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-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-2021-P-0885

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at 20 mg and 40 mg strengths, NDA Number N019462 held by Valeant Pharmaceuticals North America LLC, was voluntarily withdrawn from commercial sale for