ANDA 217375, held by Alkem Labs Ltd. Famotidine.
As of Nov 15, 2026, ANDA 217375 (Famotidine), held by Alkem Labs Ltd, was first approved by FDA on Apr 24, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 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
