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As of Nov 15, 2026, ANDA 217655 (Famotidine), held by Somerset Theraps LLC, was first approved by FDA on Jun 16, 2023, with 1 approved supplement and 0 published complete response letters.
First approved: Jun 16, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Famotidine for oral suspension is indicated in adults for the treatment of:
reduction of the risk of duodenal ulcer recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older 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
