Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 20MG BASE | 1 | CABOMETYX | CABOZANTINIB S-MALATE |
| 002 | TABLET;ORAL | EQ 40MG BASE | 1 | CABOMETYX | CABOZANTINIB S-MALATE |
| 003 | TABLET;ORAL | EQ 60MG BASE | 1 | CABOMETYX | CABOZANTINIB S-MALATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2016-04-25 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2017-12-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2019-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2020-11-05 | N/A |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2021-01-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2021-09-17 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2022-07-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 10 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Orphan | 5 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 7 |
CDER Filings
EXELIXIS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208692
[companyName] => EXELIXIS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CABOMETYX","activeIngredients":"CABOZANTINIB S-MALATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"CABOMETYX","activeIngredients":"CABOZANTINIB S-MALATE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"CABOMETYX","activeIngredients":"CABOZANTINIB S-MALATE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/16\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208692s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208692s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208692s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208692s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208692s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208692s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208692s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208692Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208692Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/16\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208692s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208692Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"01\/31\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208692s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208692Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/14\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208692s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208692Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2017","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208692s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208692Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"11\/16\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208692Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-16
)
)