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Generated: November 19, 2018

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Details for New Drug Application (NDA): 021654

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NDA 021654 describes LOVAZA, which is a drug marketed by Smithkline Beecham and is included in one NDA. It is available from four suppliers. Additional details are available on the LOVAZA profile page.

The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
Summary for 021654
Tradename:LOVAZA
Applicant:Smithkline Beecham
Ingredient:omega-3-acid ethyl esters
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021654
Ingredient-typeFatty Acids, Omega-3
Suppliers and Packaging for NDA: 021654
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654 NDA GlaxoSmithKline LLC 0173-0783 0173-0783-02 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0783-02)
LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654 NDA GlaxoSmithKline LLC 0173-0884 0173-0884-08 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0884-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:Nov 10, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021654

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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