ANDA 207480, held by Amneal. Olmesartan Medoxomil.
As of Nov 15, 2026, ANDA 207480 (Olmesartan Medoxomil), held by Amneal, was first approved by FDA on Jul 11, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2023 | Original application | Approved | None posted |
| Olmesartan Medoxomil5MG · tablet;oral | Olmesartan Medoxomil | Discontinued |
| Olmesartan Medoxomil20MG · tablet;oral | Olmesartan Medoxomil | Discontinued |
| Olmesartan Medoxomil40MG · tablet;oral | Olmesartan Medoxomil | 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
