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Last Updated: December 15, 2025

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, Ascent Pharms Inc, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Onesource Specialty, Puracap Pharm Llc, Sofgen Pharms, Sun Pharm, Wilshire Pharms Inc, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from eighteen 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 203893
Tradename:OMEGA-3-ACID ETHYL ESTERS
Applicant:Onesource Specialty
Ingredient:omega-3-acid ethyl esters
Patents:0
Pharmacology for NDA: 203893
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)
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 203893 ANDA American Health Packaging 60687-846 60687-846-65 50 BLISTER PACK in 1 CARTON (60687-846-65) / 1 CAPSULE in 1 BLISTER PACK (60687-846-11)

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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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