FDA — authorised 14 September 2016
- Application: NDA205103
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: YOSPRALA
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised PA32540 on 14 September 2016
Yes. FDA authorised it on 14 September 2016.
GENUS LIFESCIENCES holds the US marketing authorisation.