FDA — authorised 30 January 2009
- Application: NDA022287
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: DEXILANT
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised Dexlansoprazole MR on 30 January 2009
Yes. FDA authorised it on 30 January 2009.
TAKEDA PHARMS USA holds the US marketing authorisation.