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Treats pathological hypersecretory conditions. ANDA 75805, held by Carlsbad. Famotidine.
As of Nov 15, 2026, ANDA 75805 (Famotidine), held by Carlsbad, was first approved by FDA on Apr 16, 2001, with 3 approved supplements and 0 published complete response letters.
First approved: Apr 16, 2001
Supplements approved: 3
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 above for the treatment of:
reduction of the risk of duodenal ulcer recurrence. Famotidine is a histamine-2 (H 2 ) receptor antagonist indicated: In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer.
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
