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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Medtronic
Boehringer Ingelheim
Teva
Covington
Daiichi Sankyo
Citi
McKinsey
Argus Health
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Generated: October 23, 2017

DrugPatentWatch Database Preview

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 six 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. Twenty-one suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for NDA: 021654

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
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)

Summary 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 Orange Book 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;ORAL021654-001Nov 10, 2004► Subscribe► Subscribe
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 2004► Subscribe► Subscribe
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 2004► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Dow
US Department of Justice
Moodys
Chinese Patent Office
Farmers Insurance
Teva
Boehringer Ingelheim
Julphar

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