FDA — authorised 10 December 1997
- Application: NDA020675
- Marketing authorisation holder: ABBVIE
- Status: supplemented
FDA authorised URSO Forte on 10 December 1997
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 10 December 1997; FDA has authorised it.
ABBVIE holds the US marketing authorisation.