FDA — authorised 15 September 1999
- Application: NDA050778
- Marketing authorisation holder: PFIZER INC
- Local brand name: ELLENCE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Epirubicin (E) on 15 September 1999
Yes. FDA authorised it on 15 September 1999.
PFIZER INC holds the US marketing authorisation.