Last Updated: August 10, 2026

Details for New Drug Application (NDA): 216811

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NDA 216811 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 216811

Tradename:	ICOSAPENT ETHYL
Applicant:	Ascent Pharms Inc
Ingredient:	icosapent ethyl
Patents:	0

Suppliers and Packaging for NDA: 216811

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	216811	ANDA	Northstar Rx LLC	16714-636	16714-636-01	120 CAPSULE in 1 BOTTLE (16714-636-01)
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	216811	ANDA	Camber Pharmaceuticals, Inc.	31722-298	31722-298-24	240 CAPSULE in 1 BOTTLE (31722-298-24)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Dec 7, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Feb 16, 2024	TE:	AB	RLD:	No

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