Treats pathological hypersecretory conditions. ANDA 75786, held by Chartwell Rx. Famotidine.
As of Nov 15, 2026, ANDA 75786 (Famotidine), held by Chartwell Rx, was first approved by FDA on Apr 16, 2001, with 3 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 tablets 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 |
|---|---|---|---|
| Apr 16, 2001 | Original application | Approved |
| Famotidine20MG · tablet;oral | Famotidine | Rx |
| Famotidine40MG · tablet;oral | Famotidine | Rx |
| Feb 19, 2021 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 12, 2012 | Supplement 4Labeling | Approved | None posted |
| Nov 26, 2004 | Supplement 2Labeling | 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
