Treats pathological hypersecretory conditions. ANDA 216427, held by Amneal. Famotidine.
As of Nov 15, 2026, ANDA 216427 (Famotidine), held by Amneal, was first approved by FDA on Aug 4, 2022, with 0 approved supplements and 0 published complete response letters.
Famotidine for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). 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: peptic ulcer disease. GERD with or without esophagitis and ulcerations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine40MG/5ML · for suspension;oral | Famotidine | Rx |
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
