Treats pathological hypersecretory conditions. ANDA 215630, held by Vkt Pharma. Famotidine.
As of Nov 15, 2026, ANDA 215630 (Famotidine), held by Vkt Pharma, was first approved by FDA on Jan 7, 2022, with 1 approved supplement 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 (H2) 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 |
|---|---|---|---|
| Jan 7, 2022 | Original application | Approved | None posted |
| Famotidine20MG · tablet;oral | Famotidine | Rx |
| Famotidine40MG · tablet;oral | Famotidine | Rx |
| Jul 5, 2023 | Supplement 3Manufacturing | Approved | None posted |
| Jan 7, 2022 | Original application | Approved | None posted |
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
