Treats hypertension. ANDA 207135, held by Pharmazone. Olmesartan Medoxomil.
As of Nov 15, 2026, ANDA 207135 (Olmesartan Medoxomil), held by Pharmazone, was first approved by FDA on Jul 18, 2019, with 1 approved supplement and 0 published complete response letters.
1. INDICATIONS AND USAGE Olmesartan medoxomil is 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 |
|---|---|---|---|
| Jul 18, 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 |
| Nov 17, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 18, 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
