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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077909

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NDA 077909 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 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-two suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 077909
Tradename:FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Renaissance Ssa Llc
Ingredient:fluconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077909
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 077909 ANDA Baxter Healthcare Corporation 36000-002 36000-002-06 6 BAG in 1 CARTON (36000-002-06) > 100 mL in 1 BAG
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 077909 ANDA Baxter Healthcare Corporation 36000-002 36000-002-10 10 BAG in 1 CARTON (36000-002-10) > 100 mL in 1 BAG

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/50ML (2MG/ML)
Approval Date:Apr 20, 2015TE:RLD:No

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