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Details for New Drug Application (NDA): 022186

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NDA 022186 describes AK-FLUOR 25%, which is a drug marketed by Akorn and is included in one NDA. It is available from one supplier. 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. Two suppliers are listed for this compound. Additional details are available on the fluorescein sodium profile page.

Summary for NDA: 022186

Tradename:
AK-FLUOR 10%
Applicant:
Akorn
Ingredient:
fluorescein sodium
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 022186

Mechanism of ActionDyes

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:Aug 8, 2008TE:APRLD:No

Summary for product number 002

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


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