FDA — authorised 28 June 2012
- Application: NDA202611
- Marketing authorisation holder: APGDI
- Local brand name: MYRBETRIQ
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Bladogra on 28 June 2012
Yes. FDA authorised it on 28 June 2012.
APGDI holds the US marketing authorisation.