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Details for New Drug Application (NDA): 076042

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NDA 076042 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, Aurobindo Pharm, Mylan, Glenmark Generics, Unique Pharm Labs, Dr Reddys Labs Inc, Apotex, Teva, Idt Australia Ltd, Ranbaxy Labs Ltd, Hospira, Hikma Farmaceutica, Claris, Mylan Labs Ltd, Fresenius Kabi Usa, Teva Pharms Usa, Eurohlth Intl Sarl, Acs Dobfar Info Sa, Teva Pharms, and Baxter Hlthcare, and is included in thirty-nine 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-eight suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 076042

Mylan Pharms Inc
Therapeutic Class:Antifungals

Suppliers and Packaging for NDA: 076042

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 076042 ANDA REMEDYREPACK INC. 49349-729 49349-729-02 30 TABLET in 1 BLISTER PACK (49349-729-02)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Jul 29, 2004TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Jul 29, 2004TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Jul 29, 2004TE:RLD:No

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