🇺🇸 Ursochol oral tablet in United States

Ursochol oral tablet (Ursochol oral tablet) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Ursochol oral tablet in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Ursochol oral tablet approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Ursochol oral tablet in United States?

Universitaire Ziekenhuizen KU Leuven is the originator. The local marketing authorisation holder may differ — check the official source linked above.