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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076658

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NDA 076658 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 Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, Norvium Bioscience, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, Zydus Pharms, Hikma Farmaceutica, Hospira, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, Mylan Labs Ltd, and West-ward Pharms Int, and is included in forty-two NDAs. It is available from thirty-eight 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-five suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for 076658

Tradename:	FLUCONAZOLE
Applicant:	Dr Reddys Labs Inc
Ingredient:	fluconazole
Patents:	0

Pharmacology for NDA: 076658

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 076658

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors

Suppliers and Packaging for NDA: 076658

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUCONAZOLE	fluconazole	TABLET;ORAL	076658	ANDA	Major Pharmaceuticals	0904-6500	0904-6500-06	50 BLISTER PACK in 1 CARTON (0904-6500-06) / 1 TABLET in 1 BLISTER PACK
FLUCONAZOLE	fluconazole	TABLET;ORAL	076658	ANDA	Major Pharmaceuticals	0904-6500	0904-6500-61	100 BLISTER PACK in 1 CARTON (0904-6500-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 29, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 29, 2004	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jul 29, 2004	TE:	AB	RLD:	No

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