FDA — authorised 10 October 2019
- Application: NDA200655
- Marketing authorisation holder: FEINSTEIN
- Local brand name: FLUORODOPA F18
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Fluorodopa F18 in United States
FDA authorised Fluorodopa F18 on 10 October 2019
Marketing authorisations
FDA
- Marketing authorisation holder: FEINSTEIN
- Status: approved
Fluorodopa F18 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Fluorodopa F18 approved in United States?
Yes. FDA authorised it on 10 October 2019; FDA has authorised it.
Who is the marketing authorisation holder for Fluorodopa F18 in United States?
FEINSTEIN holds the US marketing authorisation.