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Generated: August 21, 2018

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Details for New Drug Application (NDA): 020596

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NDA 020596 describes EPIVIR, which is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. It is available from five suppliers. There is one patent 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-nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the lamivudine profile page.
Summary for 020596
Tradename:EPIVIR
Applicant:Viiv Hlthcare
Ingredient:lamivudine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 020596
Medical Subject Heading (MeSH) Categories for 020596
Suppliers and Packaging for NDA: 020596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIVIR lamivudine SOLUTION;ORAL 020596 NDA ViiV Healthcare Company 49702-205 N 49702-205-48

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Nov 17, 1995TE:AARLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 20, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Healthtrust
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Queensland Health
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