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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 three 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. Three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the fosamprenavir calcium profile page.

Summary for NDA: 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 49349-811-02 30 TABLET, FILM COATED in 1 BLISTER PACK (49349-811-02)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 700MG BASE
Approval Date:Oct 20, 2003TE:ABRLD:Yes
Patent:6,436,989*PEDPatent Expiration:Jun 24, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,514,953*PEDPatent Expiration:Jan 15, 2020Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Oct 27, 2015
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY


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