Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 0.5MG | 1 | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE |
| 002 | TABLET;ORAL | EQ 1MG | 1 | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE |
| 003 | TABLET;ORAL | EQ 2MG | 1 | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2013-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2014-08-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-09-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2015-11-20 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2017-06-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-02-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2018-04-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-03-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2018-05-04 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2019-10-06 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2020-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2020-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2021-05-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2022-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2021-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2022-01-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2022-05-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2022-06-22 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
CDER Filings
NOVARTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 204114
[companyName] => NOVARTIS
[docInserts] => ["",""]
[products] => [{"drugName":"MEKINIST","activeIngredients":"TRAMETINIB DIMETHYL SULFOXIDE","strength":"EQ 0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"MEKINIST","activeIngredients":"TRAMETINIB DIMETHYL SULFOXIDE","strength":"EQ 1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MEKINIST","activeIngredients":"TRAMETINIB DIMETHYL SULFOXIDE","strength":"EQ 2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/204114s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2021","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204114s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2021","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204114s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204114s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/09\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204114s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204114s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204114s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2018","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204114Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2018","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204114s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204114s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204114s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204114s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204114s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2015","submission":"SUPPL-4","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204114s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2014","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204114s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204114s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/29\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204114s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204114Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204114Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204114Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/22\/2022","submission":"SUPPL-24","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/204114s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/204114Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"05\/27\/2022","submission":"SUPPL-23","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/204114s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/204114Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2022","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/204114s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/204114Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"12\/03\/2021","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204114s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/204114Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2022","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/204114s019lbl.pdf\"},{\"name\":\"Letter 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204114Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"10\/06\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204114s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204114Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"05\/04\/2018","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204114Orig1s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204114Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"03\/09\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204114s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204114Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/30\/2018","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204114s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204114Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"02\/24\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204114s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204114Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/22\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204114s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204114Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/20\/2015","submission":"SUPPL-4","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204114s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204114Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/26\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/13\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/08\/2014","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204114s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204114Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2022-06-22
)
)