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Generated: September 26, 2018

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Details for New Drug Application (NDA): 203893

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NDA 203893 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. Nineteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
Summary for 203893
Tradename:OMEGA-3-ACID ETHYL ESTERS
Applicant:Strides Pharma
Ingredient:omega-3-acid ethyl esters
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203893
Ingredient-typeFatty Acids, Omega-3
Suppliers and Packaging for NDA: 203893
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 203893 ANDA Par Pharmaceutical Inc. 0254-3010 0254-3010-08 120 CAPSULE in 1 BOTTLE (0254-3010-08)

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:Sep 19, 2017TE:ABRLD:No

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