🇺🇸 Abilify in United States

FDA authorised Abilify on 15 November 2002

Marketing authorisations

FDA — authorised 15 November 2002

  • Application: NDA021436
  • Marketing authorisation holder: OTSUKA
  • Status: supplemented

FDA — authorised 28 February 2013

  • Application: NDA202971
  • Marketing authorisation holder: OTSUKA PHARM CO LTD
  • Status: supplemented

FDA — authorised 13 November 2017

  • Application: NDA207202
  • Marketing authorisation holder: OTSUKA
  • Status: supplemented

FDA — authorised 27 April 2023

  • Application: NDA217006
  • Marketing authorisation holder: OTSUKA
  • Status: approved

FDA

  • Status: approved

Abilify 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 Abilify approved in United States?

Yes. FDA authorised it on 15 November 2002; FDA authorised it on 28 February 2013; FDA authorised it on 13 November 2017.

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

OTSUKA holds the US marketing authorisation.