🇺🇸 ZIPRASIDONE in United States

FDA authorised ZIPRASIDONE on 2 March 2012

Marketing authorisations

FDA — authorised 2 March 2012

  • Application: ANDA077561
  • Marketing authorisation holder: APOTEX
  • Status: supplemented

FDA — authorised 2 March 2012

  • Application: ANDA077565
  • Marketing authorisation holder: DR REDDYS LABS INC
  • Status: supplemented

FDA — authorised 5 September 2012

  • Application: ANDA090348
  • Marketing authorisation holder: CHARTWELL RX
  • Status: supplemented

FDA — authorised 26 December 2019

  • Application: ANDA211908
  • Marketing authorisation holder: GLAND
  • Status: approved

FDA — authorised 3 September 2025

  • Application: ANDA217595
  • Marketing authorisation holder: STERISCIENCE
  • Status: approved

FDA

  • Status: approved

ZIPRASIDONE in other countries

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

Frequently asked questions

Is ZIPRASIDONE approved in United States?

Yes. FDA authorised it on 2 March 2012; FDA authorised it on 2 March 2012; FDA authorised it on 5 September 2012.

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

APOTEX holds the US marketing authorisation.