Sold as Funduscein-25, Fluorescite, Ak-Fluor 10%, Ak-Fluor 25%. Every FDA application for this active ingredient: 3 branded and 3 generic.
As of Nov 15, 2026, FDA lists 6 applications for Fluorescein Sodium (sold as Funduscein-25, Fluorescite, Ak-Fluor 10% and others), first approved Nov 10, 1976, with 0 new uses approved and 0 published complete response letters.
| A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.Keratitis, Autoimmunity · Guangdong ProCapZoom Biosciences Co., Ltd. | Phase 1 | Not yet recruiting | Oct 29, 2026 |
| Real-time Fluorescence Microscopy for Intraoperative Assessment of Prostate Biopsy Cores (FLASH)Prostate Cancer (Diagnosis), Prostatic Neoplasms · Shanghai East Hospital | — | Not yet recruiting | Sep 29, 2026 |
| Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary LesionsPeripheral Pulmonary Lesions · First Affiliated Hospital of Ningbo University | — | Not yet recruiting | Sep 18, 2026 |
| Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic PatientsMeibomian Gland Dysfunction, Dry Eye Syndromes · Assiut University | — | Not yet recruiting | Sep 9, 2026 |
| Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological AnalysesGlioblastoma · Patrick Morris | Not applicable | Recruiting | Jul 28, 2026 |
| Ocular Manifestations of Granulomatosis With Polyangiitis.GPA, Vasculitis · Military Institute od Medicine National Research Institute | — | Recruiting | Jun 24, 2026 |
| Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy PatientsHead and Neck Disorder, Head and Neck Cancer · Matthew Spector | Phase 2 | Recruiting | Jun 8, 2026 |
| TearCare in Young AdultsMeibomian Gland Dysfunction (Disorder) · University of Alabama at Birmingham | Not applicable | Not yet recruiting | May 11, 2026 |
| Nov 10, 1976 | Funduscein-25NDA 17869 · New molecular entity | Novartis | 5 | Discontinued |
| Mar 28, 2006 | FluoresciteNDA 21980 · New formulation or manufacturer | Alcon Labs Inc | 5 | Marketed |
| Aug 8, 2008 | Ak-Fluor 10%, Ak-Fluor 25%NDA 22186 · New dosage form | Long Grove Pharms | 3 | Marketed |
| Sep 25, 2023 | Fluorescein SodiumANDA 215709 | Nexus | 0 | Marketed |
| Apr 30, 2026 | Fluorescein SodiumANDA 220046 | Bpi Labs | 0 | Marketed |
| Jun 1, 2026 | Fluorescein SodiumANDA 218651 | Zydus Lifesciences | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Novartis
Alcon Labs Inc
Zydus Lifesciences