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Last Updated: December 5, 2023

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 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. Seventeen 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:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021004

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 021004

Anti-HIV Agents
Reverse Transcriptase Inhibitors

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:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/ML
Approval Date:	Dec 8, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 021004

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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