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Data updated: Sep 20, 2026

AK-FLUOR 10% (fluorescein sodium) · LONG GROVE PHARMS

Ophthalmology Approved 2008-08-08

INDICATIONS For testing tear film stability by determining the fluorescein break-up time (FBUT).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
18
Years on Market

Details

Status
Prescription
First Approved
2008-08-08
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

LONG GROVE PHARMS
Active Ingredient: FLUORESCEIN SODIUM

AK-FLUOR 10% Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2008 to 2026
Mar 2026 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Feb 2025 SUPPL
Label · Labeling
FDA Letter Label
Jul 2015 SUPPL
Mfg · Manufacturing (CMC)

What AK-FLUOR 10% Treats

1 FDA approvals

Originally approved for its first indication in 2008 .

  • Other (1)
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Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT06873815 25-002 Ph 2 recruiting A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
NCT06054178 results posted 71857 R25DC020174-03 Ph 2 completed Identification of Nerves Using Fluorescein Sodium
NCT05664555 DOSE B-2211-790-004 Ph 4 completed Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study)
NCT04351373 results posted 19-005178 Ph 2 completed Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
NCT04071080 PH1.20180001 Ph 1 completed The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
NCT02028325 Fluorescein results posted GCBS-0003 Ph 4 terminated Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AK-FLUOR 10% FDA Label Details

Indications & Usage

FDA Label (PDF)

INDICATIONS For testing tear film stability by determining the fluorescein break-up time (FBUT).

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Data Sources

FDA Approval: NDA022186 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.