🇺🇸 Codeine only in United States

Codeine only (Codeine only) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Codeine 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 Codeine only approved in United States?

Yes. FDA has authorised it.

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

Mayo Clinic is the originator. The local marketing authorisation holder may differ — check the official source linked above.