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Last Updated: March 17, 2025

Details for New Drug Application (NDA): 077731

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NDA 077731 describes FLUCONAZOLE, which is a drug marketed by Aurobindo Pharma, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Zhejiang Poly Pharm, 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, and Mylan Labs Ltd, 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 077731

Tradename:	FLUCONAZOLE
Applicant:	Aurobindo Pharma
Ingredient:	fluconazole
Patents:	0

Pharmacology for NDA: 077731

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

Medical Subject Heading (MeSH) Categories for 077731

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

Suppliers and Packaging for NDA: 077731

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUCONAZOLE	fluconazole	TABLET;ORAL	077731	ANDA	NorthStar Rx LLC	16714-691	16714-691-01	30 TABLET in 1 BOTTLE (16714-691-01)
FLUCONAZOLE	fluconazole	TABLET;ORAL	077731	ANDA	NorthStar Rx LLC	16714-691	16714-691-02	100 TABLET in 1 BOTTLE (16714-691-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Oct 7, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Oct 7, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Oct 7, 2008	TE:	AB	RLD:	No

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