FDA — authorised 4 October 1995
- Application: NDA020498
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CASODEX
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Casodex on 4 October 1995
Yes. FDA authorised it on 4 October 1995.
ANI PHARMS holds the US marketing authorisation.