NDA 204308, held by Azurity. Enalapril Maleate.
As of Nov 13, 2026, NDA 204308 (Epaned Kit), held by Azurity, was first approved by FDA on Aug 13, 2013, with 7 approved supplements and 0 published complete response letters.
| Sep 4, 2014 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 4, 2014 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Aug 13, 2013 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epaned Kit1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for solution;oral | Enalapril Maleate | DiscontinuedReference drug |
| Jul 28, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Mar 22, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Jan 29, 2016 | Supplement 5Labeling · Standard review | Approved | |
| Dec 28, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 4, 2014 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 4, 2014 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 3, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 13, 2013 | Original applicationNew dosage form · 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
