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Last Updated: March 19, 2026

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. 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. Two 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 20, 2003TE:RLD: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 6,436,989*PED ⤷  Get Started Free
Viiv Hlthcare LEXIVA fosamprenavir calcium TABLET;ORAL 021548-001 Oct 20, 2003 6,514,953*PED ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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