FDA — authorised 20 February 2001
- Application: NDA021153
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: NEXIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
🇺🇸 Stomopral in United States
FDA authorised Stomopral on 20 February 2001
Marketing authorisations
FDA — authorised 27 February 2008
- Application: NDA022101
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: NEXIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Stomopral approved in United States?
Yes. FDA authorised it on 20 February 2001; FDA authorised it on 27 February 2008.
Who is the marketing authorisation holder for Stomopral in United States?
ASTRAZENECA holds the US marketing authorisation.