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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076303

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NDA 076303 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Hospira, Acs Dobfar Info Sa, West-ward Pharms Int, Renaissance Ssa Llc, Teva Pharms, Baxter Hlthcare, Mylan Labs Ltd, and Hikma Farmaceutica, and is included in nine NDAs. It is available from five 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-one suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 076303

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

Suppliers and Packaging for NDA: 076303

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 076303 ANDA Hospira, Inc. 0409-4688 0409-4688-12 24 BAG in 1 CASE (0409-4688-12) > 200 mL in 1 BAG (0409-4688-16)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION 076303 ANDA Hospira, Inc. 0409-4688 0409-4688-18 24 BAG in 1 CASE (0409-4688-18) > 100 mL in 1 BAG (0409-4688-22)

Summary for product number 001

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

Summary 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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