ANDA 75634, held by Chartwell Injectable. Enalaprilat.
As of Nov 15, 2026, ANDA 75634 (Enalaprilat), held by Chartwell Injectable, was first approved by FDA on Aug 22, 2000, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enalaprilat1.25MG/ML ยท injectable;injection | Enalaprilat | Rx |
| May 27, 2010 | Supplement 7Labeling | Approved | None posted |
| Apr 3, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Aug 22, 2000 | Original application | 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
