Details for New Drug Application (NDA): 090973

NDA 090973 describes OMEGA-3-ACID ETHYL ESTERS, which is a drug marketed by Amneal Pharms, Apotex, Ascent Pharms Inc, Bionpharma, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Slayback Pharma Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, and Zydus, 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 090973

Tradename:	OMEGA-3-ACID ETHYL ESTERS
Applicant:	Apotex
Ingredient:	omega-3-acid ethyl esters
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 090973

Suppliers and Packaging for NDA: 090973

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	090973	ANDA	Major Pharmaceuticals	0904-6706	0904-6706-06	50 BLISTER PACK in 1 CARTON (0904-6706-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	090973	ANDA	AvKARE	42291-657	42291-657-12	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-657-12)

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:	Sep 30, 2014	TE:	AB	RLD:	No

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