FDA — authorised 14 January 2013
- Application: NDA203634
- Marketing authorisation holder: SALIX
- Status: supplemented
🇺🇸 Uceris in United States
FDA authorised Uceris on 14 January 2013
Marketing authorisations
FDA — authorised 7 October 2014
- Application: NDA205613
- Marketing authorisation holder: SALIX
- Status: approved
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Uceris approved in United States?
Yes. FDA authorised it on 14 January 2013; FDA authorised it on 7 October 2014; FDA has authorised it.
Who is the marketing authorisation holder for Uceris in United States?
SALIX holds the US marketing authorisation.