FDA — authorised 30 May 2023
- Application: ANDA214862
- Marketing authorisation holder: APOTEX
- Local brand name: OBETICHOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ocaliva in United States
FDA authorised Ocaliva on 30 May 2023
Marketing authorisation
Other Other approved in United States
Frequently asked questions
Is Ocaliva approved in United States?
Yes. FDA authorised it on 30 May 2023.
Who is the marketing authorisation holder for Ocaliva in United States?
APOTEX holds the US marketing authorisation.