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Last Updated: May 28, 2020

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Details for New Drug Application (NDA): 208963

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NDA 208963 describes FLUCONAZOLE, which is a drug marketed by Aurobindo Pharma Ltd, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Ani Pharms Inc, Aurobindo Pharma, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Unique Pharm Labs, Zydus Pharms, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, West-ward Pharms Int, Baxter Hlthcare, and Inforlife, and is included in forty NDAs. It is available from thirty-two 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 208963
Applicant:Zydus Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE fluconazole TABLET;ORAL 208963 ANDA A-S Medication Solutions 50090-4425 50090-4425-0 1 BLISTER PACK in 1 CARTON (50090-4425-0) > 1 TABLET in 1 BLISTER PACK
FLUCONAZOLE fluconazole TABLET;ORAL 208963 ANDA A-S Medication Solutions 50090-4864 50090-4864-1 30 TABLET in 1 BOTTLE (50090-4864-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 16, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Feb 16, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Feb 16, 2017TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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