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PEPCID (famotidine) for Suspension, 40 mg/5 mL, NDA Number 019527, held by Salix Pharmaceuticals Inc., was voluntarily withdrawn from the market for safety or effectiveness reasons.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