FDA — authorised 8 June 2006
- Application: ANDA076674
- Marketing authorisation holder: COREPHARMA
- Indication: Labeling
- Status: approved
🇺🇸 Zestril in United States
FDA authorised Zestril on 8 June 2006
Marketing authorisations
FDA — authorised 20 February 2013
- Application: ANDA076059
- Marketing authorisation holder: WATSON LABS
- Indication: Labeling
- Status: approved
FDA — authorised 2 June 2015
- Application: ANDA203508
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 4 January 2016
- Application: ANDA075743
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
FDA — authorised 28 July 2017
- Application: NDA208401
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
Zestril 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 Zestril approved in United States?
Yes. FDA authorised it on 8 June 2006; FDA authorised it on 20 February 2013; FDA authorised it on 2 June 2015.
Who is the marketing authorisation holder for Zestril in United States?
COREPHARMA holds the US marketing authorisation.