Liptruzet

NDA 200153, held by Organon. Atorvastatin Calcium; Ezetimibe.

As of Nov 15, 2026, NDA 200153 (Liptruzet), held by Organon, was first approved by FDA on May 3, 2013, with 8 approved supplements and 0 published complete response letters.

First approved: May 3, 2013
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
May 3, 2013	Original applicationTYPE 2/4 · Standard review	Approved	Review Summary Review Label Letter

Products

4 strengths and forms


LiptruzetEQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Atorvastatin Calcium; Ezetimibe	DiscontinuedReference drug
LiptruzetEQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Atorvastatin Calcium; Ezetimibe	DiscontinuedReference drug
LiptruzetEQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Atorvastatin Calcium; Ezetimibe	DiscontinuedReference drug
LiptruzetEQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Atorvastatin Calcium; Ezetimibe	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Oct 28, 2024	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 28, 2024	Supplement 13Labeling · Standard review	Approved	Letter Label
Oct 28, 2024	Supplement 14Labeling · Standard review	Approved	Letter Label
Sep 25, 2020	Supplement 12Labeling	Approved	Label Letter
Sep 28, 2017	Supplement 5Labeling · Standard review	Approved	Label Letter
Aug 4, 2017	Supplement 6Labeling · Standard review	Approved	Label Letter
May 16, 2014	Supplement 3Manufacturing · Standard review	Approved	Letter Label
Feb 13, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
May 3, 2013	Original applicationTYPE 2/4 · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 200153
Drugs@FDA: Overview at FDA
Company: Organon

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters