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Serving leading biopharmaceutical companies globally:

McKinsey
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Moodys
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Mallinckrodt
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Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091028

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NDA 091028 describes OMEGA-3-ACID ETHYL ESTERS, which is a drug marketed by Par Pharm Inc, Teva Pharms Usa, Amneal Pharms, Apotex Inc, and Strides Pharma, 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 091028

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091028

Ingredient-typeFatty Acids, Omega-3

Suppliers and Packaging for NDA: 091028

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 091028 ANDA Teva Pharmaceuticals USA Inc 0093-5401 0093-5401-89 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-5401-89)

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:Apr 7, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Harvard Business School
QuintilesIMS
Fuji
Boehringer Ingelheim
US Department of Justice
Moodys
Chinese Patent Office
Medtronic

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