Details for New Drug Application (NDA): 215458

NDA 215458 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 215458

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

Pharmacology for NDA: 215458

Suppliers and Packaging for NDA: 215458

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	215458	ANDA	Major Pharmaceuticals	0904-7495	0904-7495-06	50 BLISTER PACK in 1 CARTON (0904-7495-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	215458	ANDA	Lifestar Pharma LLC	70756-423	70756-423-22	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (70756-423-22)

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 15, 2021	TE:	AB	RLD:	No

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