Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 200153
Company: MERCK SHARP DOHME
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ATORVASTATIN CALCIUM; EZETIMIBE EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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ATORVASTATIN CALCIUM; EZETIMIBE EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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ATORVASTATIN CALCIUM; EZETIMIBE EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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ATORVASTATIN CALCIUM; EZETIMIBE EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English