FDA — authorised 10 November 1976
- Application: NDA017869
- Marketing authorisation holder: NOVARTIS
- Local brand name: FUNDUSCEIN-25
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 FLUORESCEIN SODIUM in United States
FDA authorised FLUORESCEIN SODIUM on 10 November 1976 · 294 US adverse-event reports
Marketing authorisations
FDA — authorised 8 August 2008
- Application: NDA022186
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: AK-FLUOR 10%
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 March 2020
- Application: NDA211039
- Marketing authorisation holder: BAUSCH LOMB IRELAND
- Status: approved
FDA — authorised 25 September 2023
- Application: ANDA215709
- Marketing authorisation holder: NEXUS
- Local brand name: FLUORESCEIN SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 April 2026
- Application: ANDA220046
- Marketing authorisation holder: BPI LABS
- Local brand name: FLUORESCEIN SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
The FDA approved FLUORESCEIN SODIUM for intravenous use on 30 April 2026. This approval was granted to BPI Labs, the marketing authorisation holder. The approval was based on a standard application, not an expedited pathway.
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 294
Most-reported reactions
- Pruritus — 50 reports (17.01%)
- Nausea — 39 reports (13.27%)
- Anaphylactic Shock — 31 reports (10.54%)
- Dizziness — 30 reports (10.2%)
- Rash — 30 reports (10.2%)
- Vomiting — 29 reports (9.86%)
- Loss Of Consciousness — 23 reports (7.82%)
- Hyperhidrosis — 21 reports (7.14%)
- Urticaria — 21 reports (7.14%)
- Anaphylactic Reaction — 20 reports (6.8%)
FLUORESCEIN SODIUM 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 FLUORESCEIN SODIUM approved in United States?
Yes. FDA authorised it on 10 November 1976; FDA authorised it on 8 August 2008; FDA authorised it on 9 March 2020.
Who is the marketing authorisation holder for FLUORESCEIN SODIUM in United States?
NOVARTIS holds the US marketing authorisation.