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Cerilliant
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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077253

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NDA 077253 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, Baxter Hlthcare, Inforlife, and Teva Pharms, and is included in forty NDAs. It is available from forty-four 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-one suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 077253
Tradename:FLUCONAZOLE
Applicant:Glenmark Generics
Ingredient:fluconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE fluconazole TABLET;ORAL 077253 ANDA Blenheim Pharmacal, Inc. 10544-610 E 10544-610-03
FLUCONAZOLE fluconazole TABLET;ORAL 077253 ANDA Blenheim Pharmacal, Inc. 10544-855 E 10544-855-91

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 25, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 25, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 25, 2006TE:ABRLD:No

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