FDA — authorised 26 April 2016
- Application: NDA208090
- Marketing authorisation holder: COLLEGIUM PHARM INC
- Local brand name: XTAMPZA ER
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Xtampza ER on 26 April 2016
Yes. FDA authorised it on 26 April 2016.
COLLEGIUM PHARM INC holds the US marketing authorisation.