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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Accenture
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Covington
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Federal Trade Commission
Chinese Patent Office
Fuji
Dow
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091018

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NDA 091018 describes OMEGA-3-ACID ETHYL ESTERS, which is a drug marketed by Par Pharm Inc, Teva Pharms Usa, Amneal Pharms, and Apotex Inc, and is included in four NDAs. It is available from thirteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for NDA: 091018

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

Pharmacology for NDA: 091018

Ingredient-typeFatty Acids, Omega-3

Suppliers and Packaging for NDA: 091018

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 091018 ANDA Par Pharmaceutical, Inc. 49884-019 49884-019-02 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49884-019-02)
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL 091018 ANDA Par Pharmaceutical, Inc. 49884-019 49884-019-08 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49884-019-08)

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:Jun 24, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Express Scripts
Deloitte
Chubb
US Department of Justice
Argus Health
McKesson
Cantor Fitzgerald
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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