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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
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Chinese Patent Office
Boehringer Ingelheim
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078698

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NDA 078698 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Acs Dobfar Info Sa, Baxter Hlthcare, Hikma Farmaceutica, Hospira, 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 078698
Tradename:FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Hikma Farmaceutica
Ingredient:fluconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078698
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 078698 ANDA West-Ward Pharmaceutical Corp 0143-9668 0143-9668-06 6 CONTAINER in 1 CARTON (0143-9668-06) > 200 mL in 1 CONTAINER (0143-9668-01)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078698 ANDA West-Ward Pharmaceutical Corp 0143-9669 0143-9669-06 6 CONTAINER in 1 CARTON (0143-9669-06) > 100 mL in 1 CONTAINER (0143-9669-01)

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 leading biopharmaceutical companies globally:

US Department of Justice
Moodys
Teva
McKinsey
Daiichi Sankyo
Colorcon
Covington
Baxter
Dow

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