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Fluconazole - Generic Drug Details

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Fluconazole is the generic ingredient in eight branded drugs marketed by Hospira, Acs Dobfar Info Sa, Eurohlth Intl Sarl, Taro, Claris, Roxane, Taro Pharm Inds, Ivax Sub Teva Pharms, Harris Pharm, Pliva, Aurobindo Pharma, Sun Pharm Inds Ltd, Gedeon Richter Usa, Hikma Farmaceutica, Teva Pharms, Mylan Pharms Inc, Fresenius Kabi Usa, West-ward Pharms Int, Pfizer, Aurobindo Pharm, Mylan, Teva Pharms Usa, Glenmark Generics, Unique Pharm Labs, Dr Reddys Labs Inc, Apotex, Baxter Hlthcare, Teva, Idt Australia Ltd, Ranbaxy Labs Ltd, and Mylan Labs Ltd, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for fluconazole. Forty-seven suppliers are listed for this compound.

Summary for Generic Name: fluconazole

Tradenames:8
Patents:0
Applicants:31
NDAs:42
Drug Master File Entries: see list23
Suppliers / Packagers: see list47
Bulk Api Vendors: see list90
Clinical Trials: see list52
Patent Applications: see list9,909
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: fluconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-003Jan 29, 1990RXYes► subscribe► subscribe
Glenmark Generics
FLUCONAZOLE
fluconazole
TABLET;ORAL077253-002Jan 25, 2006RXNo► subscribe► subscribe
Claris
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION077947-001May 26, 2010RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: fluconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION019950-001Jan 29, 19904,404,216*PED► subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-001Jan 29, 19904,404,216*PED► subscribe
Pfizer
DIFLUCAN
fluconazole
FOR SUSPENSION;ORAL020090-001Dec 23, 19934,404,216*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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