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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200153
Company: ORGANON

Summary Review

Products on NDA 200153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200153

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2013	ORIG-1	Approval	Type 2 New Active Ingredient and Type 4 New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200153s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200153Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153_liptruzet_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200153Orig1s009, 200153Orig1s013, 200153Orig1s014ltr.pdf
10/28/2024	SUPPL-13	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200153Orig1s009, 200153Orig1s013, 200153Orig1s014ltr.pdf
09/25/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200153s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200153Orig1s012ltr.pdf
10/28/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200153Orig1s009, 200153Orig1s013, 200153Orig1s014ltr.pdf
08/04/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200153Orig1s006ltr.pdf
09/28/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200153Orig1s005ltr.pdf
05/16/2014	SUPPL-3	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200153s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200153Orig1s003ltr.pdf
02/13/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 200153

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf
10/28/2024	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf
10/28/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf
10/28/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf
09/25/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200153s012lbl.pdf
09/28/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s005lbl.pdf
08/04/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s006lbl.pdf
05/16/2014	SUPPL-3	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200153s003lbl.pdf
05/03/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200153s000lbl.pdf

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