🇺🇸 Orectalip in United States

Orectalip (Orectalip) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Orectalip in other countries

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

Other Other approved in United States

Frequently asked questions

Is Orectalip approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Orectalip in United States?

Sinphar Pharmaceutical Co., Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.