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Generated: September 21, 2017

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Details for New Drug Application (NDA): 077523

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NDA 077523 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, Mylan Labs Ltd, Renaissance Ssa Llc, Fresenius Kabi Usa, Baxter Hlthcare Corp, Teva Pharms Usa, Acs Dobfar Info Sa, Teva Pharms, and Baxter Hlthcare, and is included in forty NDAs. It is available from forty-three 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 NDA: 077523

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

Suppliers and Packaging for NDA: 077523

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE
fluconazole
FOR SUSPENSION;ORAL 077523 ANDA Teva Pharmaceuticals USA Inc 0093-5414 0093-5414-95 35 mL in 1 BOTTLE (0093-5414-95)
FLUCONAZOLE
fluconazole
FOR SUSPENSION;ORAL 077523 ANDA Teva Pharmaceuticals USA Inc 0093-5415 0093-5415-95 35 mL in 1 BOTTLE (0093-5415-95)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength50MG/5ML
Approval Date:Sep 12, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Sep 12, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Julphar
Chubb
Medtronic
Novartis
Farmers Insurance
Cerilliant
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Boehringer Ingelheim
Fish and Richardson

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