Treats pathological hypersecretory conditions. NDA 219935, held by Sagent. Famotidine.
As of Nov 13, 2026, NDA 219935 (Famotidine), held by Sagent, was first approved by FDA on Jul 16, 2025, with 0 approved supplements and 0 published complete response letters.
Famotidine Injection is indicated for use in hospitalized adults, or as an alternative to oral famotidine 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 endoscopy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. FAMOTIDINE Injection is a histamine-2 (H 2 ) receptor antagonist indicated: In hospitalized adults, or as an alternative to oral famotidine in adults, for the treatment of: active duodenal ulcer (DU).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine20MG/5ML (4MG/ML) · solution;intravenous | Famotidine | DiscontinuedReference drug |
| Famotidine40MG/10ML (4MG/ML) · solution;intravenous | Famotidine | DiscontinuedReference drug |
| Famotidine200MG/50ML (4MG/ML) · solution;intravenous | Famotidine | DiscontinuedReference drug |
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
