Details for New Drug Application (NDA): 020090

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NDA 020090 describes DIFLUCAN, which is a drug marketed by Pfizer and is included in three NDAs. It is available from two suppliers. Additional details are available on the DIFLUCAN profile page.

The generic ingredient in DIFLUCAN 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 020090

Tradename:	DIFLUCAN
Applicant:	Pfizer
Ingredient:	fluconazole
Patents:	0

Pharmacology for NDA: 020090

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

Medical Subject Heading (MeSH) Categories for 020090

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

Suppliers and Packaging for NDA: 020090

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090	NDA	Roerig	0049-3450	0049-3450-19	1 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE
DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-5029	59762-5029-1	1 BOTTLE in 1 CARTON (59762-5029-1) / 35 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	50MG/5ML
Approval Date:	Dec 23, 1993	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML
Approval Date:	Dec 23, 1993	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020090

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	4,404,216*PED	⤷ Subscribe
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-002	Dec 23, 1993	4,416,682	⤷ Subscribe
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-002	Dec 23, 1993	4,404,216*PED	⤷ Subscribe
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	4,416,682	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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