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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

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. 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-three 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   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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