FDA — authorised 22 March 2017
- Application: ANDA207809
- Marketing authorisation holder: ALVOGEN
- Local brand name: MELPHALAN
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Lenalidomide and melphalan on 22 March 2017
Yes. FDA authorised it on 22 March 2017.
ALVOGEN holds the US marketing authorisation.