FDA — authorised 17 February 1981
- Application: NDA018107
- Marketing authorisation holder: CARDINAL HEALTH 414
- Status: supplemented
🇺🇸 TECHNETIUM TC-99M in United States
FDA authorised TECHNETIUM TC-99M on 17 February 1981
Marketing authorisations
FDA — authorised 10 January 1986
- Application: NDA018321
- Marketing authorisation holder: CURIUM
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 February 1988
- Application: NDA017538
- Marketing authorisation holder: CURIUM
- Indication: Labeling
- Status: approved
FDA — authorised 22 September 2008
- Application: ANDA078098
- Marketing authorisation holder: CURIUM
- Indication: Labeling
- Status: approved
FDA — authorised 29 April 2009
- Application: ANDA078806
- Marketing authorisation holder: JUBILANT DRAXIMAGE
- Status: supplemented
FDA — authorised 19 September 2018
- Application: NDA019829
- Marketing authorisation holder: GE HEALTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 30 January 2023
- Application: NDA216820
- Marketing authorisation holder: JUBILANT DRAXIMAGE
- Status: approved
FDA — authorised 29 September 2023
- Application: NDA022335
- Marketing authorisation holder: CYCLOMEDICA
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 26 March 2025
- Application: ANDA215146
- Marketing authorisation holder: CURIUM
- Status: approved
TECHNETIUM TC-99M 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 TECHNETIUM TC-99M approved in United States?
Yes. FDA authorised it on 17 February 1981; FDA authorised it on 10 January 1986; FDA authorised it on 22 February 1988.
Who is the marketing authorisation holder for TECHNETIUM TC-99M in United States?
CARDINAL HEALTH 414 holds the US marketing authorisation.