Treats hypertension. ANDA 206922, held by Accord Hlthcare. Eplerenone.
As of Nov 15, 2026, ANDA 206922 (Eplerenone), held by Accord Hlthcare, was first approved by FDA on Jul 13, 2017, with 3 approved supplements and 0 published complete response letters.
Eplerenone is an aldosterone antagonist indicated for: Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Heart Failure Post-Myocardial Infarction Eplerenone is indicated to improve survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2017 | Original application | Approved | None posted |
| Eplerenone25MG · tablet;oral | Eplerenone | Rx |
| Eplerenone50MG · tablet;oral | Eplerenone | Rx |
| Aug 17, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 17, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 3, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 13, 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
