Details for New Drug Application (NDA): 020564

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NDA 020564 describes EPIVIR, which is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. It is available from one supplier. Additional details are available on the EPIVIR profile page.

The generic ingredient in EPIVIR is lamivudine. There are twenty-nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

Summary for 020564

Tradename:	EPIVIR
Applicant:	Viiv Hlthcare
Ingredient:	lamivudine
Patents:	0

Pharmacology for NDA: 020564

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 020564

Anti-HIV Agents
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 020564

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPIVIR	lamivudine	TABLET;ORAL	020564	NDA	ViiV Healthcare Company	49702-203	49702-203-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-203-18)
EPIVIR	lamivudine	TABLET;ORAL	020564	NDA	ViiV Healthcare Company	49702-204	49702-204-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-204-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Nov 17, 1995	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jun 24, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020564

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	5,047,407*PED	⤷ Subscribe
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	5,047,407*PED	⤷ Subscribe
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	6,180,639*PED	⤷ Subscribe
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	5,905,082*PED	⤷ Subscribe
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	7,119,202*PED	⤷ Subscribe
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	6,180,639*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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