Details for New Drug Application (NDA): 021267

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NDA 021267 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-one suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 021267

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

Pharmacology for NDA: 021267

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

Medical Subject Heading (MeSH) Categories for 021267

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

Suppliers and Packaging for NDA: 021267

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VFEND	voriconazole	POWDER;INTRAVENOUS	021267	NDA	Roerig	0049-3190	0049-3190-01	1 VIAL, SINGLE-USE in 1 CARTON (0049-3190-01) / 20 mL in 1 VIAL, SINGLE-USE
VFEND	voriconazole	POWDER;INTRAVENOUS	021267	NDA	Roerig	0049-3190	0049-3190-28	1 VIAL, SINGLE-DOSE in 1 CARTON (0049-3190-28) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	200MG/VIAL
Approval Date:	May 24, 2002	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021267

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002	6,632,803	⤷ Get Started Free
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002	5,116,844	⤷ Get Started Free
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002	5,773,443	⤷ Get Started Free
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002	5,376,645	⤷ Get Started Free
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002	5,567,817	⤷ Get Started Free
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002	5,364,938	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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