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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021654


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NDA 021654 describes LOVAZA, which is a drug marketed by Woodward 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. Twenty-two 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:Woodward
Ingredient:omega-3-acid ethyl esters
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:Nov 10, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021654

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Woodward LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ⤷  Sign Up ⤷  Sign Up
Woodward LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ⤷  Sign Up ⤷  Sign Up
Woodward LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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