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Last Updated: April 15, 2021

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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. There is one patent 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. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
Summary for 021548
Applicant:Viiv Hlthcare
Ingredient:fosamprenavir calcium
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)
Paragraph IV (Patent) Challenges for 021548
Tradename Dosage Ingredient NDA Submissiondate
LEXIVA TABLET;ORAL fosamprenavir calcium 021548 2012-01-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 700MG BASE
Approval Date:Oct 20, 2003TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 15, 2020Product Flag?Substance Flag?Delist Request?

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