Details for New Drug Application (NDA): 021503

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NDA 021503 describes VIRACEPT, which is a drug marketed by Agouron Pharms and is included in three NDAs. It is available from one supplier. Additional details are available on the VIRACEPT profile page.

The generic ingredient in VIRACEPT is nelfinavir mesylate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nelfinavir mesylate profile page.

Summary for 021503

Tradename:	VIRACEPT
Applicant:	Agouron Pharms
Ingredient:	nelfinavir mesylate
Patents:	0

Pharmacology for NDA: 021503

Mechanism of Action	Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Medical Subject Heading (MeSH) Categories for 021503

HIV Protease Inhibitors

Suppliers and Packaging for NDA: 021503

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503	NDA	AGOURON	63010-027	63010-027-70	120 TABLET, FILM COATED in 1 BOTTLE (63010-027-70)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 625MG BASE
Approval Date:	Apr 30, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021503

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503-001	Apr 30, 2003	⤷ Sign Up	⤷ Sign Up
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503-001	Apr 30, 2003	⤷ Sign Up	⤷ Sign Up
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503-001	Apr 30, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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