Treats pathological hypersecretory conditions. ANDA 218181, held by Rising. Famotidine.
As of Nov 15, 2026, ANDA 218181 (Famotidine), held by Rising, was first approved by FDA on Dec 22, 2023, with 0 approved supplements and 0 published complete response letters.
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater 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. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2023 | Original application | Approved | None posted |
| Famotidine20MG · tablet;oral | Famotidine | Rx |
| Famotidine40MG · tablet;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
