FDA — authorised 24 December 1985
- Application: NDA018998
- Marketing authorisation holder: BAUSCH
- Local brand name: VASOTEC
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Vasotec in United States
FDA authorised Vasotec on 24 December 1985
Marketing authorisations
FDA — authorised 9 February 1988
- Marketing authorisation holder: BIOVAIL LABS INTL
- Status: approved
FDA — authorised 9 February 1988
- Application: NDA019309
- Marketing authorisation holder: BIOVAIL LABS INTL
- Local brand name: VASOTEC
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075571
- Marketing authorisation holder: HOSPIRA
- Local brand name: ENALAPRILAT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075578
- Marketing authorisation holder: DR REDDYS
- Local brand name: ENALAPRILAT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075456
- Marketing authorisation holder: HOSPIRA
- Local brand name: ENALAPRILAT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075634
- Marketing authorisation holder: CHARTWELL INJECTABLE
- Local brand name: ENALAPRILAT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075458
- Marketing authorisation holder: HOSPIRA
- Local brand name: ENALAPRILAT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 2008
- Application: ANDA078687
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: ENALAPRILAT
- Indication: INJECTABLE — INJECTION
- Status: approved
Vasotec in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Vasotec approved in United States?
Yes. FDA authorised it on 24 December 1985; FDA authorised it on 9 February 1988; FDA authorised it on 9 February 1988.
Who is the marketing authorisation holder for Vasotec in United States?
BAUSCH holds the US marketing authorisation.