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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
Fuji
Argus Health
Chinese Patent Office
Medtronic
AstraZeneca
Baxter
Farmers Insurance

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076766

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NDA 076766 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Hikma Farmaceutica, Hospira, Inforlife, Mylan Labs Ltd, Renaissance Ssa Llc, Teva Pharms, and West-ward Pharms Int, and is included in nine NDAs. It is available from four suppliers. Additional details are available on the FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% 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 076766
Tradename:FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:fluconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076766
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076766 ANDA Baxter Healthcare Corporation 0338-6045 N 0338-6045-37
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076766 ANDA Baxter Healthcare Corporation 0338-6046 N 0338-6046-48

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Jul 29, 2004TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/200ML (2MG/ML)
Approval Date:Jul 29, 2004TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Johnson and Johnson
Citi
Queensland Health
Fish and Richardson
Baxter
Daiichi Sankyo
Covington
Harvard Business School

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