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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, Aurobindo Pharm, Mylan, Glenmark Generics, Unique Pharm Labs, Dr Reddys Labs Inc, Apotex, Teva, Idt Australia Ltd, Ranbaxy Labs Ltd, Hospira, Hikma Farmaceutica, Claris, Mylan Labs Ltd, Fresenius Kabi Usa, Teva Pharms Usa, Eurohlth Intl Sarl, Acs Dobfar Info Sa, Teva Pharms, and Baxter Hlthcare, and is included in thirty-nine NDAs. It is available from thirty-nine 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-seven suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 076077

Tradename:
FLUCONAZOLE
Applicant:
Ivax Sub Teva Pharms
Ingredient:
fluconazole
Patents:0
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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