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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 218899

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NDA 218899 describes ICOSAPENT ETHYL, which is a drug marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Onesource Specialty, Pharmobedient, Qilu, Teva Pharms Usa, Xiamen Lp Pharm Co, and Zydus Lifesciences, and is included in eleven NDAs. It is available from seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.

Summary for 218899

Tradename:	ICOSAPENT ETHYL
Applicant:	Qilu
Ingredient:	icosapent ethyl
Patents:	0

Suppliers and Packaging for NDA: 218899

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	218899	ANDA	Qilu Pharmaceutical Co., Ltd.	67184-0582	67184-0582-1	120 CAPSULE in 1 BOTTLE (67184-0582-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Nov 20, 2024	TE:	AB	RLD:	No

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