🇺🇸 Ursodeoxycholic acid only in United States

Ursodeoxycholic acid only (Ursodeoxycholic acid only) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Ursodeoxycholic acid only 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 Ursodeoxycholic acid only approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Ursodeoxycholic acid only in United States?

West China Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.