ANDA 75312, held by Teva. Famotidine.
As of Nov 15, 2026, ANDA 75312 (Famotidine), held by Teva, was first approved by FDA on May 31, 2001, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine10MG ยท tablet;oral | Famotidine | Discontinued |
| Mar 21, 2007 | Supplement 4Labeling | Approved | None posted |
| Feb 23, 2004 | Supplement 3Labeling | Approved | None posted |
| May 31, 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
