Details for New Drug Application (NDA): 211355

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, Puracap Pharm Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, Wilshire Pharms Inc, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-two 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-two 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	Procaps S A	49264-4274	49264-4274-1	39 BOTTLE in 1 BOX (49264-4274-1) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE
OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	211355	ANDA	Procaps S A	49264-4274	49264-4274-2	156 BOTTLE in 1 BOX (49264-4274-2) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE

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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