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Serving leading biopharmaceutical companies globally:

Colorcon
Healthtrust
QuintilesIMS
US Army
Chubb
Queensland Health
Harvard Business School
Accenture
Johnson and Johnson
Teva

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079150

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NDA 079150 describes FLUCONAZOLE, which is a drug marketed by Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, West-ward Pharms Int, Apotex, Aurobindo Pharma, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Idt Australia Ltd, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Unique Pharm Labs, Zydus Pharms Usa Inc, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Renaissance Ssa Llc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Teva Pharms Usa, Acs Dobfar Info Sa, Baxter Hlthcare, and Teva Pharms, and is included in forty NDAs. It is available from forty-five suppliers. Additional details are available on the FLUCONAZOLE profile page.

The generic ingredient in FLUCONAZOLE 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 079150

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

Suppliers and Packaging for NDA: 079150

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE fluconazole FOR SUSPENSION;ORAL 079150 ANDA NorthStar Rx LLC 16714-695 16714-695-01 1 BOTTLE in 1 CARTON (16714-695-01) > 35 mL in 1 BOTTLE
FLUCONAZOLE fluconazole FOR SUSPENSION;ORAL 079150 ANDA NorthStar Rx LLC 16714-696 16714-696-01 1 BOTTLE in 1 CARTON (16714-696-01) > 35 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength50MG/5ML
Approval Date:Sep 18, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Sep 18, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cerilliant
Dow
Colorcon
Deloitte
Teva
AstraZeneca
Chinese Patent Office
Express Scripts
Accenture
Novartis

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