Orange Book product · Generic (ANDA)

FLUORESCEIN SODIUM

Generic (ANDA)ANDA 220046TE APRX BPI LABS

View FLUORESCEIN SODIUM family Open on FDA Orange Book

At a glance

Apr 30, 2026

Approved

Generic (ANDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Apr 30, 2026
2 mo ago
Today

Pharmaceutical detail

Active ingredient

FLUORESCEIN SODIUM

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

ANDA 220046

Product number

001

Marketing status

Reference listed drug (RLD)

Reference standard (RS)

Active-ingredient family

View full family

Generic (ANDA) of FLUORESCEIN SODIUM

AK-FLUOR 10%Brand (NDA)
NDA 022186 · LONG GROVE PHARMS
2008
FLUORESCITEBrand (NDA)
NDA 021980 · ALCON LABS INC
2006
FUNDUSCEIN-25Brand (NDA)
NDA 017869 · NOVARTIS
—
FLUORESCEIN SODIUMGeneric (ANDA)
ANDA 218651 · ZYDUS LIFESCIENCES
2026
FLUORESCEIN SODIUMGeneric (ANDA)
ANDA 215709 · NEXUS
2023

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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