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Generated: June 24, 2018

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 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 suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
Summary for 091028
Tradename:OMEGA-3-ACID ETHYL ESTERS
Applicant:Teva Pharms Usa
Ingredient:omega-3-acid ethyl esters
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 N 0093-5401-89
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 091028 ANDA QPharma Inc 42708-067 N 42708-067-28

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:Apr 7, 2014TE:ABRLD:No

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