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FDA NDA · NDA022186

AK-FLUOR

fluorescein

Sponsor: LONG GROVE PHARMS

APPLICATION
NDA022186
TYPE
NDA
ORIGINAL APPROVAL
2008-08-08
LATEST ACTION
2026-03-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

AK-FLUOR 25% · ReferenceDiscontinued
FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) · INJECTABLE · INTRAVENOUS
AK-FLUOR 10% · ReferencePrescription
FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) · INJECTABLE · INTRAVENOUS

Approval history

2026-03-17Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2025-02-28Labeling · Supplement 13 · standard — Label ↗AP
2015-07-20Manufacturing (CMC) · Supplement 2 · standardAP
2008-08-08Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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