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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209437

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NDA 209437 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 209437

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

Suppliers and Packaging for NDA: 209437

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	209437	ANDA	Golden State Medical Supply, Inc.	60429-005	60429-005-12	120 CAPSULE in 1 BOTTLE (60429-005-12)
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	209437	ANDA	Apotex Corp	60505-4033	60505-4033-1	120 CAPSULE in 1 BOTTLE (60505-4033-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Jun 30, 2021	TE:	AB	RLD:	No

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