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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 seven suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the EPIVIR profile page.

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

Summary for NDA: 020564

Tradename:
EPIVIR
Applicant:
Viiv Hlthcare
Ingredient:
lamivudine
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 KAISER FOUNDATION HOSPITALS 0179-0087 0179-0087-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0087-70)
EPIVIR
lamivudine
TABLET;ORAL 020564 NDA Rebel Distributors Corp 21695-367 21695-367-06 6 TABLET, FILM COATED in 1 BOTTLE (21695-367-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 17, 1995TE:ABRLD:No
Patent:5,905,082*PEDPatent Expiration:Nov 18, 2016Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Mar 23, 2018
Regulatory Exclusivity Use:ONCE DAILY DOSING IN PEDIATRIC PATIENTS 3 MONTHS OF AGE AND OLDER IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jun 24, 2002TE:ABRLD:Yes
Patent:5,905,082*PEDPatent Expiration:Nov 18, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book 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;ORAL020564-003Jun 24, 20025,047,407*PED► subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-003Jun 24, 20025,905,082*PED► subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 19955,047,407*PED► subscribe
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