FDA — authorised 21 June 1976
- Application: NDA017557
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: DANOCRINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Danazol Capsules on 21 June 1976
Yes. FDA authorised it on 21 June 1976.
SANOFI AVENTIS US holds the US marketing authorisation.