🇺🇸 Drug: "Abatacept" in United States

FDA authorised Drug: "Abatacept" on 8 June 1992

Marketing authorisations

FDA — authorised 8 June 1992

  • Application: NDA020066
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 12 April 1993

  • Application: NDA019658
  • Marketing authorisation holder: BAYER HEALTHCARE LLC
  • Status: supplemented

FDA — authorised 8 December 1995

  • Application: NDA019835
  • Marketing authorisation holder: KENVUE BRANDS
  • Status: supplemented

FDA — authorised 16 December 2008

  • Application: ANDA079096
  • Marketing authorisation holder: AMNEAL PHARMS NY
  • Status: supplemented

FDA — authorised 28 December 2012

  • Application: ANDA202071
  • Marketing authorisation holder: SHREE HARI INTL
  • Status: approved

FDA

  • Status: approved

Drug: "Abatacept" 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 Drug: "Abatacept" approved in United States?

Yes. FDA authorised it on 8 June 1992; FDA authorised it on 12 April 1993; FDA authorised it on 8 December 1995.

Who is the marketing authorisation holder for Drug: "Abatacept" in United States?

HALEON US HOLDINGS holds the US marketing authorisation.