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Treats pathological hypersecretory conditions. ANDA 215767, held by Annora Pharma. Famotidine.
As of Nov 15, 2026, ANDA 215767 (Famotidine), held by Annora Pharma, was first approved by FDA on Nov 4, 2021, with 0 approved supplements and 0 published complete response letters.
First approved: Nov 4, 2021
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are a histamine-2 (H 2 ) receptor antagonist indicated: In adult and pediatric patients 40 kg and greater for the treatment of:
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
