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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Covington
Julphar
Colorcon
Fuji
Argus Health
AstraZeneca
Mallinckrodt
UBS

Generated: January 23, 2018

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 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 091018
Tradename:OMEGA-3-ACID ETHYL ESTERS
Applicant:Par Pharm Inc
Ingredient:omega-3-acid ethyl esters
Patents:0
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)

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:Jun 24, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Dow
UBS
Baxter
Fuji
US Army
Citi
Cantor Fitzgerald
Deloitte
Farmers Insurance

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