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Last Updated: January 1, 2026

Details for New Drug Application (NDA): 209525

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NDA 209525 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 sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.

Summary for 209525

Tradename:	ICOSAPENT ETHYL
Applicant:	Teva Pharms Usa
Ingredient:	icosapent ethyl
Patents:	0

Suppliers and Packaging for NDA: 209525

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	209525	ANDA	Teva Pharmaceuticals, Inc.	0480-0126	0480-0126-49	240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49)
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	209525	ANDA	Teva Pharmaceuticals, Inc.	0480-0127	0480-0127-89	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0127-89)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Sep 11, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Sep 11, 2020	TE:	AB	RLD:	No

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