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Details for New Drug Application (NDA): 076077

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NDA 076077 describes FLUCONAZOLE, which is a drug marketed by Taro, Roxane, Taro Pharm Inds, Ivax Sub Teva Pharms, Harris Pharm, Pliva, Aurobindo Pharma, Sun Pharm Inds Ltd, Gedeon Richter Usa, Mylan Pharms Inc, West-ward Pharms Int, Aurobindo Pharma Ltd, Mylan, Glenmark Generics, Unique Pharm Labs, Dr Reddys Labs Inc, Zydus Pharms Usa Inc, Apotex, Teva, Idt Australia Ltd, Ranbaxy Labs Ltd, Hospira, Hikma Farmaceutica, Claris, Mylan Labs Ltd, Fresenius Kabi Usa, Teva Pharms Usa, Acs Dobfar Info Sa, Teva Pharms, and Baxter Hlthcare, and is included in forty NDAs. It is available from forty 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. Forty-eight suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 076077

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

Suppliers and Packaging for NDA: 076077

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE
fluconazole
TABLET;ORAL 076077 ANDA IVAX Pharmaceuticals, Inc. 0172-5410 0172-5410-46 30 TABLET in 1 BOTTLE (0172-5410-46)
FLUCONAZOLE
fluconazole
TABLET;ORAL 076077 ANDA IVAX Pharmaceuticals, Inc. 0172-5410 0172-5410-60 100 TABLET in 1 BOTTLE (0172-5410-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 29, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 29, 2004TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 29, 2004TE:ABRLD:No


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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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