ANDA 218461, held by Graviti Pharms. Famotidine.
As of Nov 15, 2026, ANDA 218461 (Famotidine), held by Graviti Pharms, was first approved by FDA on Mar 14, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2024 | Original application | Approved | None posted |
| Famotidine10MG · tablet;oral | Famotidine | OTC |
| Famotidine20MG · tablet;oral | Famotidine | OTC |
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
