🇺🇸 Provera in United States

FDA authorised Provera on 18 June 1959

Marketing authorisations

FDA — authorised 18 June 1959

  • Application: NDA011839
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

FDA — authorised 29 October 1992

  • Application: NDA020246
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

FDA — authorised 17 December 2004

  • Application: NDA021583
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Provera approved in United States?

Yes. FDA authorised it on 18 June 1959; FDA authorised it on 29 October 1992; FDA authorised it on 17 December 2004.

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

PFIZER holds the US marketing authorisation.