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LOVAZA Drug Profile

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Lovaza is a drug marketed by Smithkline Beecham and is included in one NDA. It is available from six suppliers.

The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for Tradename: LOVAZA

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list6

Pharmacology for Tradename: LOVAZA

Clinical Trials for: LOVAZA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 2004RXYes<disabled><disabled>
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Expired Patents for Tradename: LOVAZA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 20045,502,077<disabled>
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 20045,698,594<disabled>
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Paragraph IV activity for: LOVAZA

Drugname Dosage Strength RLD Submissiondate
omega-3-acid ethyl estersCapsules1 gLovaza11/10/2008
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