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Last Updated: December 9, 2019

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Details for New Drug Application (NDA): 022116

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NDA 022116 describes LEXIVA, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from two suppliers. 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 022116
Tradename:LEXIVA
Applicant:Viiv Hlthcare
Ingredient:fosamprenavir calcium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEXIVA fosamprenavir calcium SUSPENSION;ORAL 022116 NDA ViiV Healthcare Company 49702-208 49702-208-53 225 mL in 1 BOTTLE (49702-208-53)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrengthEQ 50MG BASE/ML
Approval Date:Jun 14, 2007TE:RLD:Yes

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