Last Updated: August 8, 2026

Details for New Drug Application (NDA): 218949

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NDA 218949 describes ICOSAPENT ETHYL, which is a drug marketed by Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Humanwell Puracap, Onesource Specialty, Qilu, Teva Pharms Usa, Torrent, Xiamen Lp Pharm Co, and Zydus Lifesciences, and is included in twelve NDAs. It is available from eighteen suppliers. Additional details are available on the ICOSAPENT ETHYL profile page.

The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.

Summary for 218949

Tradename:	ICOSAPENT ETHYL
Applicant:	Aurobindo Pharma Ltd
Ingredient:	icosapent ethyl
Patents:	0

Suppliers and Packaging for NDA: 218949

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	218949	ANDA	Aurobindo Pharma Limited	59651-812	59651-812-08	120 CAPSULE in 1 BOTTLE (59651-812-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Jun 24, 2026	TE:	AB	RLD:	No

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