FDA — authorised 26 January 2016
- Application: NDA208056
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: DEXILANT SOLUTAB
- Indication: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Empirical therapy group in United States
FDA authorised Empirical therapy group on 26 January 2016
Marketing authorisations
FDA — authorised 19 April 2017
- Application: ANDA202294
- Marketing authorisation holder: PH HEALTH
- Local brand name: DEXLANSOPRAZOLE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 16 September 2022
- Application: ANDA202666
- Marketing authorisation holder: TWI PHARMS
- Local brand name: DEXLANSOPRAZOLE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
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
Empirical therapy group in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Empirical therapy group approved in United States?
Yes. FDA authorised it on 26 January 2016; FDA authorised it on 19 April 2017; FDA authorised it on 16 September 2022.
Who is the marketing authorisation holder for Empirical therapy group in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.