FDA — authorised 17 March 2015
- Application: NDA205750
- Marketing authorisation holder: MIRUM
- Local brand name: CHOLBAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Cholbam on 17 March 2015
Yes. FDA authorised it on 17 March 2015; FDA has authorised it.
MIRUM holds the US marketing authorisation.