FDA — authorised 21 December 1990
- Application: NDA019785
- Marketing authorisation holder: SHINE
- Status: supplemented
🇺🇸 Technetium Tc99m Sestamibi in United States
FDA authorised Technetium Tc99m Sestamibi on 21 December 1990
Marketing authorisations
FDA — authorised 28 April 2009
- Application: ANDA078809
- Marketing authorisation holder: CARDINAL HEALTH 414
- Status: approved
Other Cardiovascular approved in United States
Frequently asked questions
Is Technetium 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 Technetium Tc99m Sestamibi in United States?
SHINE holds the US marketing authorisation.