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Federal Trade Commission
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Generated: April 24, 2018

DrugPatentWatch Database Preview

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 four suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Five 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:2
Therapeutic Class:Antivirals
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 REMEDYREPACK INC. 49349-811 N 49349-811-02
LEXIVA fosamprenavir calcium TABLET;ORAL 021548 NDA ViiV Healthcare Company 49702-207 N 49702-207-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 700MG BASE
Approval Date:Oct 20, 2003TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 24, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 15, 2020Product Flag?Substance Flag?Delist Request?Y

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