ANDA 75799, held by Hikma. Famotidine.
As of Nov 15, 2026, ANDA 75799 (Famotidine), held by Hikma, was first approved by FDA on Apr 30, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2002 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine10MG/ML ยท injectable;injection | Famotidine | Discontinued |
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