FDA — authorised 28 March 2006
- Application: NDA021980
- Marketing authorisation holder: ALCON LABS INC
- Local brand name: FLUORESCITE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 Fluorescite in United States
FDA authorised Fluorescite on 28 March 2006
Marketing authorisations
FDA — authorised 9 March 2020
- Marketing authorisation holder: BAUSCH
- Status: approved
Fluorescite in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Fluorescite approved in United States?
Yes. FDA authorised it on 28 March 2006; FDA authorised it on 9 March 2020.
Who is the marketing authorisation holder for Fluorescite in United States?
ALCON LABS INC holds the US marketing authorisation.