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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Federal Trade Commission
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Medtronic
Covington
Farmers Insurance
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Colorcon

Generated: December 14, 2017

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 sixteen 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:1
Applicant:1
Ingredient:1
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 16714-660-01 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (16714-660-01)
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 204940 ANDA Atlantic Biologicals Corps 17856-0034 17856-0034-2 50 CAPSULE, LIQUID FILLED in 1 POUCH (17856-0034-2)

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 27, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
McKinsey
Chubb
QuintilesIMS
Fuji
Colorcon
Merck
Federal Trade Commission
Cerilliant

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