Treats hypertension. ANDA 211049, held by Sunshine. Olmesartan Medoxomil.
As of Nov 15, 2026, ANDA 211049 (Olmesartan Medoxomil), held by Sunshine, was first approved by FDA on Feb 22, 2019, with 1 approved supplement and 0 published complete response letters.
Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2019 | 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 |
| Aug 21, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 22, 2019 | Original application | Approved | None posted |
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
