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Queensland Health
Colorcon
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Federal Trade Commission
Fuji
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Mallinckrodt

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204940

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NDA 204940 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 204940
Tradename:OMEGA-3-ACID ETHYL ESTERS
Applicant:Amneal Pharms
Ingredient:omega-3-acid ethyl esters
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204940
Ingredient-typeFatty Acids, Omega-3
Suppliers and Packaging for NDA: 204940
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 204940 ANDA NorthStar Rx LLC 16714-660 N 16714-660-01
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 204940 ANDA Atlantic Biologicals Corps 17856-0034 N 17856-0034-2

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 27, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Daiichi Sankyo
Accenture
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Federal Trade Commission
Covington
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Citi

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