FDA — authorised 30 January 2009
- Application: NDA022287
- Marketing authorisation holder: TAKEDA PHARMS USA
- Status: supplemented
🇺🇸 Dexilant in United States
FDA authorised Dexilant on 30 January 2009
Marketing authorisations
FDA — authorised 19 January 2024
- Application: ANDA205205
- Marketing authorisation holder: MYLAN
- Local brand name: DEXLANSOPRAZOLE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Dexilant in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Dexilant approved in United States?
Yes. FDA authorised it on 30 January 2009; FDA authorised it on 19 January 2024; FDA has authorised it.
Who is the marketing authorisation holder for Dexilant in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.