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Last Updated: April 5, 2026

Details for New Drug Application (NDA): 218994

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NDA 218994 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 218994

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

Profile for product number 001

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

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