Documents
Application Sponsors
| NDA 200153 | MERCK SHARP DOHME | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE |
| 002 | TABLET;ORAL | EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE |
| 003 | TABLET;ORAL | EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE |
| 004 | TABLET;ORAL | EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE |
FDA Submissions
| TYPE 2/4; Type 2 New Active Ingredient and Type 4 New Combination | ORIG | 1 | AP | 2013-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2014-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-09-25 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 12 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 200153
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"LIPTRUZET","activeIngredients":"ATORVASTATIN CALCIUM; EZETIMIBE","strength":"EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LIPTRUZET","activeIngredients":"ATORVASTATIN CALCIUM; EZETIMIBE","strength":"EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LIPTRUZET","activeIngredients":"ATORVASTATIN CALCIUM; EZETIMIBE","strength":"EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LIPTRUZET","activeIngredients":"ATORVASTATIN CALCIUM; EZETIMIBE","strength":"EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/200153s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200153s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200153s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200153s003lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/03\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200153s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/03\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 New Active Ingredient and Type 4 New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200153s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200153Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/200153_liptruzet_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/200153Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/200153s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/200153Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"08\/04\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200153s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200153Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"09\/28\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200153s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200153Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"05\/16\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200153s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200153Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"02\/13\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-25
)
)