Is Enalaprilat approved by the US FDA?

Drugs@FDA lists 7 application product lines for Enalaprilat, including ENALAPRILAT (Prescription); ENALAPRILAT (Prescription); ENALAPRILAT (Prescription); VASOTEC (Discontinued); ENALAPRILAT (Discontinued).

Active substance

Enalaprilat

US FDA 7
Health Canada 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ENALAPRILAT	1.25MG/ML	injectable · injection	DR REDDYS	Prescription	22 Aug 2000
ENALAPRILAT	1.25MG/ML	injectable · injection	CHARTWELL INJECTABLE	Prescription	22 Aug 2000
ENALAPRILAT	1.25MG/ML	injectable · injection	HIKMA FARMACEUTICA	Prescription	23 Dec 2008
VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	BIOVAIL LABS INTL	Discontinued	9 Feb 1988
ENALAPRILAT	1.25MG/ML	injectable · injection	HOSPIRA	Discontinued	22 Aug 2000
ENALAPRILAT	1.25MG/ML	injectable · injection	HOSPIRA	Discontinued	22 Aug 2000
ENALAPRILAT	1.25MG/ML	injectable · injection	HOSPIRA	Discontinued	22 Aug 2000

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ENALAPRILAT INJECTION USP	02388499	1.25 MG / ML	SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.