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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076507

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NDA 076507 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 076507

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

Suppliers and Packaging for NDA: 076507

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE fluconazole TABLET;ORAL 076507 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4064 51672-4064-0 10 BLISTER PACK in 1 CARTON (51672-4064-0) > 10 TABLET in 1 BLISTER PACK
FLUCONAZOLE fluconazole TABLET;ORAL 076507 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4064 51672-4064-6 30 TABLET in 1 BOTTLE (51672-4064-6)

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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