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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 077523


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NDA 077523 describes FLUCONAZOLE, which is a drug marketed by Aurobindo Pharma, Hainan Poly, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Lupin Ltd, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, Zydus Pharms, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, and West-ward Pharms Int, and is included in forty-two 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-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 077523
Tradename:FLUCONAZOLE
Applicant:Ivax Sub Teva Pharms
Ingredient:fluconazole
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

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

Profile for product number 002

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

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