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 two 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. Sixteen 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

Pharmacology for NDA: 021003

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 021003

Anti-HIV Agents
Reverse Transcriptase Inhibitors

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 AUTHORIZED GENERIC	Prasco Laboratories	66993-478	66993-478-60	60 TABLET, FILM COATED in 1 BOTTLE (66993-478-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 8, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 021003

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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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