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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Mallinckrodt
Chubb
Boehringer Ingelheim
Fish and Richardson
Baxter
Covington
QuintilesIMS
Cerilliant

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078764

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NDA 078764 describes FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Hikma Farmaceutica, Hospira, Mylan Labs Ltd, and Renaissance Ssa Llc, 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-three suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 078764
Tradename:FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Hikma Farmaceutica
Ingredient:fluconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078764
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078764 ANDA West-Ward Pharmaceutical Corp 0143-9666 N 0143-9666-06
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078764 ANDA West-Ward Pharmaceutical Corp 0143-9667 N 0143-9667-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Jan 30, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/200ML (2MG/ML)
Approval Date:Jan 30, 2012TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Julphar
Medtronic
Healthtrust
Mallinckrodt
US Army
Covington
Harvard Business School

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