ANDA 206227, held by Chartwell Rx. Olmesartan Medoxomil.
As of Nov 15, 2026, ANDA 206227 (Olmesartan Medoxomil), held by Chartwell Rx, was first approved by FDA on Jan 25, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2024 | Original application | Approved | None posted |
| Olmesartan Medoxomil5MG · tablet;oral | Olmesartan Medoxomil | Rx |
| Olmesartan Medoxomil20MG · tablet;oral | Olmesartan Medoxomil | Rx |
| Olmesartan Medoxomil40MG · tablet;oral | Olmesartan Medoxomil | Rx |
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