Treats hypertension. NDA 208686, held by Azurity. Enalapril Maleate.
As of Nov 14, 2026, NDA 208686 (Epaned), held by Azurity, was first approved by FDA on Sep 20, 2016, with 1 approved supplement and 0 published complete response letters.
Enalapril maleate is an angiotensin-converting enzyme inhibitor indicated for: treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. treatment of symptomatic heart failure. treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. 1.1 Hypertension Enalapril maleate is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epaned1MG/ML · solution;oral | Enalapril Maleate | RxReference drug |
| Jul 28, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Sep 20, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
