Treats hypertension. ANDA 208283, held by Breckenridge. Eplerenone.
As of Nov 15, 2026, ANDA 208283 (Eplerenone), held by Breckenridge, was first approved by FDA on Sep 14, 2018, with 1 approved supplement and 0 published complete response letters.
Eplerenone Tablets are an aldosterone antagonist 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. 1.2 Hypertension Eplerenone Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 2018 | Original application | Approved | None posted |
| Eplerenone25MG · tablet;oral | Eplerenone | Rx |
| Eplerenone50MG · tablet;oral | Eplerenone | Rx |
| May 20, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 14, 2018 | 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
