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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 211355

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NDA 211355 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. Nineteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for 211355

Tradename:	OMEGA-3-ACID ETHYL ESTERS
Applicant:	Sofgen Pharms
Ingredient:	omega-3-acid ethyl esters
Patents:	0

Pharmacology for NDA: 211355

Suppliers and Packaging for NDA: 211355

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	211355	ANDA	Chartwell RX, LLC	62135-780	62135-780-12	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-780-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:	Jul 10, 2019	TE:	AB	RLD:	No

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