Treats hypertension. ANDA 78687, held by Hikma Farmaceutica. Enalaprilat.
As of Nov 15, 2026, ANDA 78687 (Enalaprilat), held by Hikma Farmaceutica, was first approved by FDA on Dec 23, 2008, with 2 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Enalaprilat injection, USP is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection, USP has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enalaprilat1.25MG/ML · injectable;injection | Enalaprilat | Rx |
| Sep 27, 2010 | Supplement 7Labeling | Approved | None posted |
| Apr 29, 2010 | Supplement 6Labeling | Approved | None posted |
| Dec 23, 2008 | 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
