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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-two 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

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
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
SOLUTION;ORAL021004-001Dec 8, 1998RE39155*PED► subscribe
SOLUTION;ORAL021004-001Dec 8, 19985,047,407*PED► subscribe
SOLUTION;ORAL021004-001Dec 8, 19985,532,246*PED► subscribe
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