FDA — authorised 30 September 1997
- Application: NDA020757
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: AVAPRO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Avapro in United States
FDA authorised Avapro on 30 September 1997
Marketing authorisations
FDA
- Status: approved
Avapro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Avapro approved in United States?
Yes. FDA authorised it on 30 September 1997; FDA has authorised it.
Who is the marketing authorisation holder for Avapro in United States?
SANOFI AVENTIS US holds the US marketing authorisation.