FDA — authorised 1 February 2013
- Application: NDA204412
- Marketing authorisation holder: ABBVIE
- Local brand name: DELZICOL
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised Delzicol on 1 February 2013
Yes. FDA authorised it on 1 February 2013.
ABBVIE holds the US marketing authorisation.