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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 three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EPIVIR-HBV profile page.

The generic ingredient in EPIVIR-HBV 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: 021004

Tradename:
EPIVIR-HBV
Applicant:
Glaxosmithkline
Ingredient:
lamivudine
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021004

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML
Approval Date:Dec 8, 1998TE:RLD:Yes
Patent:6,004,968*PEDPatent Expiration:Sep 20, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021004

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19985,047,407*PED► subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RE39155*PED► subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19987,119,202*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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