Treats pathological hypersecretory conditions. ANDA 75302, held by Mankind Pharma. Famotidine.
As of Nov 15, 2026, ANDA 75302 (Famotidine), held by Mankind Pharma, was first approved by FDA on Apr 16, 2001, with 1 approved supplement and 0 published complete response letters.
Famotidinetablets 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. Famotidinetablets 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 tablets are 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 |
|---|---|---|---|
| Apr 16, 2001 | Original application | Approved |
| Famotidine20MG · tablet;oral | Famotidine | Rx |
| Famotidine40MG · tablet;oral | Famotidine | Rx |
| Mar 25, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Apr 16, 2001 | Original application | Approved |
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
