Details for New Drug Application (NDA): 215709

NDA 215709 describes FLUORESCEIN SODIUM, which is a drug marketed by Nexus and Bausch Lomb Ireland and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FLUORESCEIN SODIUM profile page.

The generic ingredient in FLUORESCEIN SODIUM is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.

Summary for 215709

Tradename:	FLUORESCEIN SODIUM
Applicant:	Nexus
Ingredient:	fluorescein sodium
Patents:	0

Pharmacology for NDA: 215709

Mechanism of Action

Dyes

Medical Subject Heading (MeSH) Categories for 215709

Contrast Media

Fluorescent Dyes

Suppliers and Packaging for NDA: 215709

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUORESCEIN SODIUM	fluorescein sodium	INJECTABLE;INTRAVENOUS	215709	ANDA	Nexus Pharmaceuticals LLC	14789-122	14789-122-05	10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07)
FLUORESCEIN SODIUM	fluorescein sodium	INJECTABLE;INTRAVENOUS	215709	ANDA	Nexus Pharmaceuticals LLC	14789-123	14789-123-05	10 VIAL in 1 CARTON (14789-123-05) / 2 mL in 1 VIAL (14789-123-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:	Sep 25, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)
Approval Date:	Sep 25, 2023	TE:		RLD:	No

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