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Last Updated: February 23, 2020

DrugPatentWatch Database Preview

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. Twenty 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020564
Medical Subject Heading (MeSH) Categories for 020564
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:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 17, 1995TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jun 24, 2002TE:ABRLD:Yes

Expired US Patents for NDA 020564

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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