Details for New Drug Application (NDA): 021548

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NDA 021548 describes LEXIVA, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the LEXIVA profile page.

The generic ingredient in LEXIVA is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.

Summary for 021548

Tradename:	LEXIVA
Applicant:	Viiv Hlthcare
Ingredient:	fosamprenavir calcium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021548

Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors P-Glycoprotein Inducers

Suppliers and Packaging for NDA: 021548

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548	NDA	ViiV Healthcare Company	49702-207	49702-207-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-207-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 700MG BASE
Approval Date:	Oct 20, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021548

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003	See Plans and Pricing	See Plans and Pricing
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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