🇺🇸 Zyprexa in United States

FDA authorised Zyprexa on 30 September 1996

Marketing authorisations

FDA — authorised 30 September 1996

  • Application: NDA020592
  • Marketing authorisation holder: CHEPLAPHARM
  • Status: supplemented

FDA — authorised 6 April 2000

  • Application: NDA021086
  • Marketing authorisation holder: CHEPLAPHARM
  • Status: supplemented

FDA — authorised 29 March 2004

  • Application: NDA021253
  • Marketing authorisation holder: CHEPLAPHARM
  • Status: supplemented

FDA — authorised 11 December 2009

  • Application: NDA022173
  • Marketing authorisation holder: CHEPLAPHARM
  • Status: supplemented

FDA

  • Status: approved

Other Neuroscience approved in United States

Frequently asked questions

Is Zyprexa approved in United States?

Yes. FDA authorised it on 30 September 1996; FDA authorised it on 6 April 2000; FDA authorised it on 29 March 2004.

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

CHEPLAPHARM holds the US marketing authorisation.