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FDA NDA · NDA021980

FLUORESCITE

fluorescein sodium

Sponsor: ALCON LABS INC

APPLICATION
NDA021980
TYPE
NDA
ORIGINAL APPROVAL
2006-03-28
LATEST ACTION
2026-06-10
ROUTE
OPHTHALMIC, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FLUORESCITE · ReferencePrescription
FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) · INJECTABLE · INTRAVENOUS

Approval history

2026-06-10Labeling · Supplement 12 · standard — Letter ↗AP
2021-11-17Labeling · Supplement 7 · standard — Label ↗AP
2016-02-02Labeling · Supplement 4 · standard — Label ↗AP
2015-02-09Manufacturing (CMC) · Supplement 6 · priorityAP
2014-02-12Manufacturing (CMC) · Supplement 5 · priorityAP
2006-03-28Type 5 - New Formulation or New Manufacturer · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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