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Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077947

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NDA 077947 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Hikma Farmaceutica, Fresenius Kabi Usa, Baxter Hlthcare Corp, Teva Pharms Usa, West-ward Pharms Int, Hospira, Acs Dobfar Info Sa, Renaissance Ssa Llc, Teva Pharms, Baxter Hlthcare, and Mylan Labs Ltd, and is included in fourteen NDAs. It is available from two suppliers. Additional details are available on the FLUCONAZOLE IN SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% 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 077947

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

Suppliers and Packaging for NDA: 077947

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION 077947 ANDA Claris Lifesciences Inc. 36000-004 36000-004-06 6 VIAL, GLASS in 1 CARTON (36000-004-06) > 100 mL in 1 VIAL, GLASS
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION 077947 ANDA Claris Lifesciences Inc. 36000-005 36000-005-06 6 VIAL, GLASS in 1 CARTON (36000-005-06) > 200 mL in 1 VIAL, GLASS

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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