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Last Updated: May 28, 2022

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
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:RXDosage:TABLET;ORALStrengthEQ 700MG BASE
Approval Date:Oct 20, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021548

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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