FDA — authorised 14 December 2012
- Application: NDA203993
- Marketing authorisation holder: LUNDBECK PHARMS LLC
- Local brand name: ONFI
- Indication: SUSPENSION — ORAL
- Status: approved
FDA authorised Clobazam Low Dose on 14 December 2012
Yes. FDA authorised it on 14 December 2012.
LUNDBECK PHARMS LLC holds the US marketing authorisation.