ANDA 75458, held by Hospira. Enalaprilat.
As of Nov 15, 2026, ANDA 75458 (Enalaprilat), held by Hospira, was first approved by FDA on Aug 22, 2000, with 3 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 · injectable;injection | Enalaprilat | Discontinued |
| Sep 5, 2017 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 28, 2010 | Supplement 7Labeling | Approved | |
| Jun 13, 2003 | Supplement 3Labeling | 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
