Details for New Drug Application (NDA): 021630

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NDA 021630 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 021630

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

Pharmacology for NDA: 021630

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

Medical Subject Heading (MeSH) Categories for 021630

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

Suppliers and Packaging for NDA: 021630

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VFEND	voriconazole	FOR SUSPENSION;ORAL	021630	NDA	Roerig	0049-3160	0049-3160-44	1 BOTTLE in 1 CARTON (0049-3160-44) / 75 mL in 1 BOTTLE
VFEND	voriconazole	FOR SUSPENSION;ORAL	021630	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-0935	59762-0935-3	1 BOTTLE in 1 CARTON (59762-0935-3) / 75 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML
Approval Date:	Dec 19, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021630

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	VFEND	voriconazole	FOR SUSPENSION;ORAL	021630-001	Dec 19, 2003	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	VFEND	voriconazole	FOR SUSPENSION;ORAL	021630-001	Dec 19, 2003	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	VFEND	voriconazole	FOR SUSPENSION;ORAL	021630-001	Dec 19, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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