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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078107

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NDA 078107 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Dr Reddys, Hikma, Hikma Farmaceutica, Hospira, Inforlife, Mylan Labs Ltd, 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-four suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for 078107

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

Medical Subject Heading (MeSH) Categories for 078107

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	Jul 30, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	400MG/200ML (2MG/ML)
Approval Date:	Jul 30, 2008	TE:	AP	RLD:	No

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