Last Updated: May 14, 2026

Details for New Drug Application (NDA): 200153


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NDA 200153 describes LIPTRUZET, which is a drug marketed by Organon and is included in one NDA. Additional details are available on the LIPTRUZET profile page.

The generic ingredient in LIPTRUZET is atorvastatin calcium; ezetimibe. There are sixty-two drug master file entries for this compound. Additional details are available on the atorvastatin calcium; ezetimibe profile page.
Summary for 200153
Tradename:LIPTRUZET
Applicant:Organon
Ingredient:atorvastatin calcium; ezetimibe
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 3, 2013TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 3, 2013TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 3, 2013TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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