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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077988

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NDA 077988 describes FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Hospira, Hikma Farmaceutica, Claris, and Mylan Labs Ltd, and is included in four NDAs. It is available from three suppliers. Additional details are available on the FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER is fluconazole. There are twenty-three drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 077988

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077988

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION 077988 ANDA Claris Lifesciences Inc. 36000-006 36000-006-06 6 BAG in 1 CARTON (36000-006-06) > 100 mL in 1 BAG
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION 077988 ANDA Claris Lifesciences Inc. 36000-006 36000-006-10 10 BAG in 1 CARTON (36000-006-10) > 100 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:May 26, 2010TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/200ML (2MG/ML)
Approval Date:May 26, 2010TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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