Last Updated: September 24, 2026

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, Ascent Pharms Inc, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Onesource, Puracap Pharm Llc, Sofgen Pharms, Sun Pharm, Wilshire Pharms Inc, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from seventeen 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 is one drug master file entry for this compound. Seventeen 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:	Onesource
Ingredient:	omega-3-acid ethyl esters
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:	Jun 24, 2014	TE:		RLD:	No

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