Details for New Drug Application (NDA): 022186

NDA 022186 describes AK-FLUOR 25%, which is a drug marketed by Akorn and is included in one NDA. It is available from two suppliers. Additional details are available on the AK-FLUOR 25% profile page.

The generic ingredient in AK-FLUOR 25% is fluorescein sodium. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluorescein sodium profile page.

Summary for 022186

Tradename:	AK-FLUOR 25%
Applicant:	Akorn
Ingredient:	fluorescein sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022186

Mechanism of Action

Dyes

Medical Subject Heading (MeSH) Categories for 022186

Contrast Media

Fluorescent Dyes

Suppliers and Packaging for NDA: 022186

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	Akorn	17478-250	17478-250-20	12 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-250-20) / 2 mL in 1 VIAL, SINGLE-DOSE
AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	Akorn	17478-253	17478-253-10	12 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-253-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:	Aug 8, 2008	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)
Approval Date:	Aug 8, 2008	TE:		RLD:	Yes

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