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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Healthtrust
QuintilesIMS
Mallinckrodt
Colorcon
Fish and Richardson
Express Scripts
Farmers Insurance
Cerilliant

Generated: May 21, 2018

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, Ani Pharms Inc, Apotex, Aurobindo Pharma, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, 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, Baxter Hlthcare, Inforlife, and Teva Pharms, and is included in forty NDAs. It is available from forty-six 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:FLUCONAZOLE
Applicant:Aurobindo Pharma Ltd
Ingredient:fluconazole
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 N 16714-695-01
FLUCONAZOLE fluconazole FOR SUSPENSION;ORAL 079150 ANDA NorthStar Rx LLC 16714-696 N 16714-696-01

Profile for product number 001

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

Profile 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 hundreds of leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Healthtrust
Moodys
Queensland Health
Citi
Mallinckrodt
Daiichi Sankyo
Argus Health

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