Details for New Drug Application (NDA): 021266

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NDA 021266 describes VFEND, which is a drug marketed by Pf Prism Cv and is included in three NDAs. It is available from two suppliers. Additional details are available on the VFEND profile page.

The generic ingredient in VFEND is voriconazole. There are fourteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 021266

Tradename:	VFEND
Applicant:	Pf Prism Cv
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 021266

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

Medical Subject Heading (MeSH) Categories for 021266

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 021266

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VFEND	voriconazole	TABLET;ORAL	021266	NDA	Roerig	0049-3170	0049-3170-30	30 TABLET, FILM COATED in 1 BOTTLE (0049-3170-30)
VFEND	voriconazole	TABLET;ORAL	021266	NDA	Roerig	0049-3180	0049-3180-30	30 TABLET, FILM COATED in 1 BOTTLE (0049-3180-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 24, 2002	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 24, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021266

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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