← FDA DRUG APPROVALS

FDA NDA · NDA200153

LIPTRUZET

Sponsor: ORGANON

APPLICATION
NDA200153
TYPE
NDA
ORIGINAL APPROVAL
2013-05-03
LATEST ACTION
2024-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LIPTRUZET · ReferenceDiscontinued
ATORVASTATIN CALCIUM EQ 40MG BASE, EZETIMIBE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LIPTRUZET · ReferenceDiscontinued
ATORVASTATIN CALCIUM EQ 10MG BASE, EZETIMIBE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LIPTRUZET · ReferenceDiscontinued
ATORVASTATIN CALCIUM EQ 80MG BASE, EZETIMIBE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LIPTRUZET · ReferenceDiscontinued
ATORVASTATIN CALCIUM EQ 20MG BASE, EZETIMIBE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-10-28Labeling · Supplement 14 · standard — Label ↗AP
2024-10-28Labeling · Supplement 13 · standard — Label ↗AP
2024-10-28Labeling · Supplement 9 · standard — Label ↗AP
2020-09-25Labeling · Supplement 12 · 901 required — Letter ↗AP
2017-09-28Labeling · Supplement 5 · standard — Label ↗AP
2017-08-04Labeling · Supplement 6 · standard — Label ↗AP
2014-05-16Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
2014-02-13Manufacturing (CMC) · Supplement 2 · standardAP
2013-05-03Type 2 New Active Ingredient and Type 4 New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →