ANDA 218631, held by Regcon Holdings. Famotidine.
As of Nov 15, 2026, ANDA 218631 (Famotidine), held by Regcon Holdings, was first approved by FDA on Mar 25, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 25, 2025 | 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
