🇺🇸 Tc99m sestamibi in United States

FDA authorised Tc99m sestamibi on 21 December 1990

Marketing authorisations

FDA — authorised 21 December 1990

  • Application: NDA019785
  • Marketing authorisation holder: SHINE
  • Status: supplemented

FDA — authorised 28 April 2009

  • Application: ANDA078809
  • Marketing authorisation holder: CARDINAL HEALTH 414
  • Status: approved

Frequently asked questions

Is Tc99m sestamibi approved in United States?

Yes. FDA authorised it on 21 December 1990; FDA authorised it on 28 April 2009.

Who is the marketing authorisation holder for Tc99m sestamibi in United States?

SHINE holds the US marketing authorisation.