Treats hypertension. ANDA 203012, held by Alembic. Olmesartan Medoxomil.
As of Nov 15, 2026, ANDA 203012 (Olmesartan Medoxomil), held by Alembic, was first approved by FDA on Apr 24, 2017, with 1 approved supplement and 0 published complete response letters.
1. INDICATIONS AND USAGE Olmesartan medoxomil is indicated for the treatment of hypertension, 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2017 | 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 |
| Jun 27, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 24, 2017 | 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
