FDA — authorised 30 September 1997
- Application: NDA020758
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: AVALIDE
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Avalide on 30 September 1997
Yes. FDA authorised it on 30 September 1997; FDA has authorised it.
SANOFI AVENTIS US holds the US marketing authorisation.