Details for New Drug Application (NDA): 204940

NDA 204940 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 204940

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

Pharmacology for NDA: 204940

Suppliers and Packaging for NDA: 204940

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	204940	ANDA	Amneal Pharmaceuticals LLC	65162-034	65162-034-06	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06)
OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	204940	ANDA	Amneal Pharmaceuticals LLC	65162-034	65162-034-16	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16)

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:	Nov 27, 2015	TE:	AB	RLD:	No

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