Last Updated: September 24, 2026

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. Additional details are available on the EPIVIR-HBV profile page.

The generic ingredient in EPIVIR-HBV is lamivudine. There is one drug master file entry for this compound. Fourteen 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

Medical Subject Heading (MeSH) Categories for 021003

Anti-HIV Agents
Reverse Transcriptase Inhibitors

Profile for product number 001

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

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