FDA — authorised 26 December 1985
- Application: NDA018677
- Marketing authorisation holder: BAUSCH
- Local brand name: CESAMET
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Nabilone, flexible dosing on 26 December 1985
Yes. FDA authorised it on 26 December 1985.
BAUSCH holds the US marketing authorisation.