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Treats pathological hypersecretory conditions. ANDA 219863, held by Msn. Famotidine.
As of Nov 15, 2026, ANDA 219863 (Famotidine), held by Msn, was first approved by FDA on Jul 24, 2025, with 0 approved supplements and 0 published complete response letters.
First approved: Jul 24, 2025
Review: Standard
Supplements approved: 0
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 DU 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
