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Generated: November 12, 2018

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Details for New Drug Application (NDA): 021003

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NDA 021003 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-six suppliers are listed for this compound. Additional details are available on the lamivudine profile page.
Summary for 021003
Tradename:EPIVIR-HBV
Applicant:Glaxosmithkline
Ingredient:lamivudine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021003
Medical Subject Heading (MeSH) Categories for 021003
Suppliers and Packaging for NDA: 021003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIVIR-HBV lamivudine TABLET;ORAL 021003 NDA GlaxoSmithKline LLC 0173-0662 0173-0662-00 60 TABLET, FILM COATED in 1 BOTTLE (0173-0662-00)
EPIVIR-HBV lamivudine TABLET;ORAL 021003 NDA State of Florida DOH Central Pharmacy 53808-0893 53808-0893-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0893-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 8, 1998TE:ABRLD:Yes

Expired US Patents for NDA 021003

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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