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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021654

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NDA 021654 describes LOVAZA, which is a drug marketed by Waylis Therap and is included in one NDA. Additional details are available on the LOVAZA profile page.

The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for 021654

Tradename:	LOVAZA
Applicant:	Waylis Therap
Ingredient:	omega-3-acid ethyl esters
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:	Nov 10, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021654

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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