ANDA 75311, held by Teva. Famotidine.
As of Nov 15, 2026, ANDA 75311 (Famotidine), held by Teva, was first approved by FDA on Apr 16, 2001, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 2001 | Original application | Approved |
| Famotidine20MG · tablet;oral | Famotidine | Discontinued |
| Famotidine40MG · tablet;oral | Famotidine | Discontinued |
| Mar 26, 2003 | Supplement 1Labeling | 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
