FDA — authorised 29 October 2014
- Application: ANDA203801
- Marketing authorisation holder: TRUSTEES UNIV PA
- Status: approved
🇺🇸 Fludeoxyglucose F-18 in United States
FDA authorised Fludeoxyglucose F-18 on 29 October 2014
Marketing authorisations
FDA — authorised 27 February 2015
- Application: ANDA204542
- Marketing authorisation holder: PRECISION NUCLEAR
- Status: approved
FDA — authorised 7 April 2015
- Application: ANDA204546
- Marketing authorisation holder: PRECISION NUCLEAR
- Status: approved
FDA — authorised 24 June 2020
- Application: ANDA203777
- Marketing authorisation holder: 3D IMAGING DRUG
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 May 2021
- Application: NDA208054
- Marketing authorisation holder: BLUE EARTH
- Indication: Labeling
- Status: approved
FDA
- Marketing authorisation holder: 3D IMAGING DRUG
- Status: approved
Fludeoxyglucose F-18 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Fludeoxyglucose F-18 approved in United States?
Yes. FDA authorised it on 29 October 2014; FDA authorised it on 27 February 2015; FDA authorised it on 7 April 2015.
Who is the marketing authorisation holder for Fludeoxyglucose F-18 in United States?
TRUSTEES UNIV PA holds the US marketing authorisation.