Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 100MG | 1 | INVOKANA | CANAGLIFLOZIN |
002 | TABLET;ORAL | 300MG | 1 | INVOKANA | CANAGLIFLOZIN |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2013-03-29 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2014-05-15 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-06-05 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2015-03-03 | STANDARD |
EFFICACY; Efficacy | SUPPL | 6 | AP | 2015-09-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2015-09-09 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2016-03-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2016-03-08 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2015-12-04 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 15 | AP | 2016-05-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2016-06-16 | STANDARD |
EFFICACY; Efficacy | SUPPL | 18 | AP | 2017-02-01 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2016-05-20 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 22 | AP | 2016-08-17 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 26 | AP | 2017-07-25 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 27 | AP | 2018-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2018-10-26 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 32 | AP | 2019-09-27 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 34 | AP | 2020-08-18 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2020-01-24 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 39 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
ORIG | 1 | Null | 40 |
SUPPL | 2 | Null | 6 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 7 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 7 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 15 |
SUPPL | 15 | Null | 15 |
SUPPL | 16 | Null | 0 |
SUPPL | 18 | Null | 7 |
SUPPL | 19 | Null | 7 |
SUPPL | 22 | Null | 6 |
SUPPL | 26 | Null | 7 |
SUPPL | 27 | Null | 7 |
SUPPL | 31 | Null | 15 |
SUPPL | 32 | Null | 6 |
SUPPL | 34 | Null | 31 |
SUPPL | 36 | Null | 6 |
SUPPL | 39 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 204042
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/204042s034lbl.pdf#page=48"]
[products] => [{"drugName":"INVOKANA","activeIngredients":"CANAGLIFLOZIN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVOKANA","activeIngredients":"CANAGLIFLOZIN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/18\/2020","submission":"SUPPL-34","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204042s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204042s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2019","submission":"SUPPL-32","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204042s032lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2018","submission":"SUPPL-27","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204042s027lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204042s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204042s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2017","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204042s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s015s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2016","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s015s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204042s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2015","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204042s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204042s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204042s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204042s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204042s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/29\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204042s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204042Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204042Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/NDA\\\/2013\\\/204042Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204042s036lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/18\/2020","submission":"SUPPL-34","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204042s034lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204042Orig1s034ltr.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2019","submission":"SUPPL-32","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204042s032lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204042Orig1s032ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/204042Orig1s032TOC.cfm\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204042s031lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204042Orig1s031ltr.pdf\"}]","notes":">"},{"actionDate":"10\/29\/2018","submission":"SUPPL-27","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204042s027lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204042Orig1s027ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2021\\\/204042Orig1s027.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204042s026lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204042Orig1s026ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/204042Orig1s026.pdf\"}]","notes":">"},{"actionDate":"08\/17\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204042Orig1s022ltr.pdf\"}]","notes":">"},{"actionDate":"05\/20\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s015s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204042Orig1s015,s019ltr.pdf\"}]","notes":">"},{"actionDate":"02\/01\/2017","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204042s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204042Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2016","submission":"SUPPL-16","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/20\/2016","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s015s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204042Orig1s015,s019ltr.pdf\"}]","notes":">"},{"actionDate":"12\/04\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204042s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204042Orig1s013ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/204042Orig1s013.pdf\"}]","notes":">"},{"actionDate":"03\/08\/2016","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/28\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204042s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204042Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"09\/09\/2015","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/10\/2015","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204042s006lbl.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204042s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204042Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"06\/05\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/15\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204042s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204042Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"11\/26\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-18
)
)