Details for New Drug Application (NDA): 019949

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NDA 019949 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-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for 019949

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

Pharmacology for NDA: 019949

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

Medical Subject Heading (MeSH) Categories for 019949

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

Suppliers and Packaging for NDA: 019949

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFLUCAN	fluconazole	TABLET;ORAL	019949	NDA	Roerig	0049-3420	0049-3420-30	30 TABLET in 1 BOTTLE (0049-3420-30)
DIFLUCAN	fluconazole	TABLET;ORAL	019949	NDA	Roerig	0049-3420	0049-3420-41	100 BLISTER PACK in 1 CARTON (0049-3420-41) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jan 29, 1990	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jan 29, 1990	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 29, 1990	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019949

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-001	Jan 29, 1990	⤷ Sign Up	⤷ Sign Up
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990	⤷ Sign Up	⤷ Sign Up
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-004	Jun 30, 1994	⤷ Sign Up	⤷ Sign Up
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990	⤷ Sign Up	⤷ Sign Up
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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