🇺🇸 Prozac in United States

FDA authorised Prozac on 29 December 1987

Marketing authorisations

FDA — authorised 29 December 1987

  • Application: NDA018936
  • Marketing authorisation holder: ELI LILLY AND CO
  • Status: supplemented

FDA

  • Status: approved

Prozac in other countries

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

Other Neuroscience approved in United States

Frequently asked questions

Is Prozac approved in United States?

Yes. FDA authorised it on 29 December 1987; FDA has authorised it.

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

ELI LILLY AND CO holds the US marketing authorisation.