Treats hypertension. ANDA 75578, held by Dr Reddys. Enalaprilat.
As of Nov 15, 2026, ANDA 75578 (Enalaprilat), held by Dr Reddys, was first approved by FDA on Aug 22, 2000, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection 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 |
|---|---|---|---|
| Aug 22, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enalaprilat1.25MG/ML · injectable;injection | Enalaprilat | Rx |
| Apr 14, 2015 | Supplement 17Labeling | Approved | None posted |
| Apr 27, 2010 | Supplement 7Labeling | Approved | None posted |
| Jan 2, 2004 | Supplement 3Labeling | Approved | None posted |
| Dec 19, 2002 | Supplement 1Labeling | 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
