🇺🇸 ICE in United States

FDA authorised ICE on 13 January 1984

Marketing authorisations

FDA — authorised 13 January 1984

  • Application: NDA018612
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 8 June 1992

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

FDA — authorised 9 October 2012

  • Application: ANDA203690
  • Marketing authorisation holder: PPI-DAC
  • Status: supplemented

FDA — authorised 26 February 2016

  • Application: ANDA204833
  • Marketing authorisation holder: P AND L
  • Status: approved

FDA — authorised 10 May 2016

  • Application: ANDA204794
  • Marketing authorisation holder: P AND L
  • Status: approved

Other Immunology approved in United States

Frequently asked questions

Is ICE approved in United States?

Yes. FDA authorised it on 13 January 1984; FDA authorised it on 8 June 1992; FDA authorised it on 9 October 2012.

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

HALEON US HOLDINGS holds the US marketing authorisation.