🇺🇸 TC in United States

FDA authorised TC on 17 February 1981

Marketing authorisations

FDA — authorised 17 February 1981

  • Application: NDA018107
  • Marketing authorisation holder: CARDINAL HEALTH 414
  • Status: supplemented

FDA — authorised 22 September 2008

  • Application: ANDA078098
  • Marketing authorisation holder: CURIUM
  • Status: supplemented

FDA — authorised 29 April 2009

  • Application: ANDA078806
  • Marketing authorisation holder: JUBILANT DRAXIMAGE
  • Status: supplemented

FDA — authorised 30 January 2023

  • Application: NDA216820
  • Marketing authorisation holder: JUBILANT DRAXIMAGE
  • Status: approved

FDA — authorised 26 March 2025

  • Application: ANDA215146
  • Marketing authorisation holder: CURIUM
  • Status: approved

Other Oncology approved in United States

Frequently asked questions

Is TC approved in United States?

Yes. FDA authorised it on 17 February 1981; FDA authorised it on 22 September 2008; FDA authorised it on 29 April 2009.

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

CARDINAL HEALTH 414 holds the US marketing authorisation.