FDA — authorised 14 January 2013
- Application: NDA203634
- Marketing authorisation holder: SALIX
- Local brand name: UCERIS
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Ekmasonid on 14 January 2013
Yes. FDA authorised it on 14 January 2013; FDA authorised it on 7 October 2014.
SALIX holds the US marketing authorisation.