🇺🇸 Risperdal in United States

FDA authorised Risperdal on 29 December 1993

Marketing authorisations

FDA — authorised 29 December 1993

  • Application: NDA020272
  • Marketing authorisation holder: JANSSEN PHARMS
  • Status: supplemented

FDA — authorised 10 June 1996

  • Application: NDA020588
  • Marketing authorisation holder: JANSSEN PHARMS
  • Status: supplemented

FDA — authorised 2 April 2003

  • Application: NDA021444
  • Marketing authorisation holder: JANSSEN PHARMS
  • Status: supplemented

FDA — authorised 29 October 2003

  • Application: NDA021346
  • Marketing authorisation holder: JANSSEN PHARMS
  • Status: supplemented

FDA

  • Status: approved

Other Neuroscience approved in United States

Frequently asked questions

Is Risperdal approved in United States?

Yes. FDA authorised it on 29 December 1993; FDA authorised it on 10 June 1996; FDA authorised it on 2 April 2003.

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

JANSSEN PHARMS holds the US marketing authorisation.