Details for New Drug Application (NDA): 077909

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NDA 077909 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Dr Reddys, Hikma Farmaceutica, Hospira, Inforlife, Mylan Labs Ltd, West-ward Pharms Int, and Woodward, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 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.

Tradename:	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:	Woodward
Ingredient:	fluconazole
Patents:	0

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

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

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	077909	ANDA	Woodward Pharma Services LLC	69784-261	69784-261-24	50 mL in 1 CONTAINER (69784-261-24)

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	May 26, 2010	TE:	AP	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	400MG/200ML (2MG/ML)
Approval Date:	May 26, 2010	TE:	AP	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/50ML (2MG/ML)
Approval Date:	Apr 20, 2015	TE:		RLD:	No

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