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US Department of Justice
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090973

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NDA 090973 describes OMEGA-3-ACID ETHYL ESTERS, which is a drug marketed by Amneal Pharms, Apotex Inc, Par Pharm Inc, Strides Pharma, and Teva Pharms Usa, and is included in five NDAs. It is available from seventeen suppliers. Additional details are available on the OMEGA-3-ACID ETHYL ESTERS profile page.

The generic ingredient in OMEGA-3-ACID ETHYL ESTERS 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 090973
Tradename:OMEGA-3-ACID ETHYL ESTERS
Applicant:Apotex Inc
Ingredient:omega-3-acid ethyl esters
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090973
Ingredient-typeFatty Acids, Omega-3
Suppliers and Packaging for NDA: 090973
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 090973 ANDA AvKARE, Inc. 42291-657 N 42291-657-12
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 090973 ANDA Apotex Corp. 60505-3170 N 60505-3170-3

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:Sep 30, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Colorcon
Express Scripts
QuintilesIMS
Harvard Business School
Accenture
Chinese Patent Office
Fuji
Cantor Fitzgerald

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