FDA — authorised 16 July 2009
- Application: NDA022266
- Marketing authorisation holder: ADALVO
- Local brand name: ONSOLIS
- Indication: FILM — BUCCAL
- Status: approved
FDA authorised BEMA Fentanyl on 16 July 2009
Yes. FDA authorised it on 16 July 2009.
ADALVO holds the US marketing authorisation.