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Generated: December 12, 2018

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Details for New Drug Application (NDA): 021004

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NDA 021004 describes EPIVIR-HBV, which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the EPIVIR-HBV profile page.

The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-nine drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the lamivudine profile page.
Summary for 021004
Tradename:EPIVIR-HBV
Applicant:Glaxosmithkline
Ingredient:lamivudine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021004
Medical Subject Heading (MeSH) Categories for 021004
Suppliers and Packaging for NDA: 021004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIVIR-HBV lamivudine SOLUTION;ORAL 021004 NDA GlaxoSmithKline LLC 0173-0663 0173-0663-00 240 mL in 1 BOTTLE (0173-0663-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML
Approval Date:Dec 8, 1998TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 20, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021004

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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