🇺🇸 "MAX-40279-01" and "Toripalimab" in United States

FDA authorised "MAX-40279-01" and "Toripalimab" on 17 October 1974

Marketing authorisations

FDA — authorised 17 October 1974

  • Application: ANDA080767
  • Marketing authorisation holder: IMPAX LABS
  • Status: supplemented

FDA — authorised 28 August 1981

  • Application: ANDA086173
  • Marketing authorisation holder: FOSUN PHARMA
  • Status: supplemented

FDA — authorised 18 December 1985

  • Application: ANDA089097
  • Marketing authorisation holder: PLIVA
  • Status: supplemented

FDA — authorised 17 September 2010

  • Application: ANDA079025
  • Marketing authorisation holder: CHARTWELL RX
  • Status: approved

FDA — authorised 1 December 2011

  • Application: NDA200403
  • Marketing authorisation holder: HOSPIRA INC
  • Status: supplemented

Other Oncology approved in United States

Frequently asked questions

Is "MAX-40279-01" and "Toripalimab" approved in United States?

Yes. FDA authorised it on 17 October 1974; FDA authorised it on 28 August 1981; FDA authorised it on 18 December 1985.

Who is the marketing authorisation holder for "MAX-40279-01" and "Toripalimab" in United States?

IMPAX LABS holds the US marketing authorisation.