Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET;ORAL | 50MG;500MG | 1 | INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
002 | TABLET;ORAL | 50MG;1GM | 1 | INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
003 | TABLET;ORAL | 150MG;500MG | 1 | INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
004 | TABLET;ORAL | 150MG;1GM | 1 | INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2014-08-08 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2015-03-03 | STANDARD |
EFFICACY; Efficacy | SUPPL | 3 | AP | 2015-09-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2015-06-08 | STANDARD |
EFFICACY; Efficacy | SUPPL | 6 | AP | 2016-05-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2015-12-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2016-03-17 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2016-03-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2016-04-14 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2015-12-04 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 14 | AP | 2017-02-01 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2016-05-20 | 901 REQUIRED |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2016-11-23 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2016-08-17 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 23 | AP | 2017-07-25 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 24 | AP | 2017-08-11 | STANDARD |
EFFICACY; Efficacy | SUPPL | 25 | AP | 2018-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2018-10-26 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 33 | AP | 2020-01-27 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2020-01-24 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 39 | AP | 2020-08-18 | STANDARD |
LABELING; Labeling | SUPPL | 41 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 6 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 7 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 10 | Null | 15 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 6 |
SUPPL | 14 | Null | 6 |
SUPPL | 15 | Null | 6 |
SUPPL | 20 | Null | 7 |
SUPPL | 23 | Null | 15 |
SUPPL | 24 | Null | 6 |
SUPPL | 25 | Null | 6 |
SUPPL | 31 | Null | 15 |
SUPPL | 33 | Null | 7 |
SUPPL | 36 | Null | 6 |
SUPPL | 39 | Null | 15 |
SUPPL | 41 | Null | 7 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 204353
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/204353s039,205879s017lbl.pdf#page=58"]
[products] => [{"drugName":"INVOKAMET","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"50MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVOKAMET","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"50MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVOKAMET","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"150MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVOKAMET","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"150MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/18\/2020","submission":"SUPPL-39","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204353s039,205879s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2020","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204353s033,205879s011lbl.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\\\/204353s036,205879s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2018","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204353s025,205879s007lbl.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\\\/204353s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204353s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204353s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204353s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s006s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2016","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s006s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204353s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2015","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204353s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204353s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/08\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204353s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/08\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204353s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204353Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204353Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204353Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/18\/2020","submission":"SUPPL-39","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204353s039,205879s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204353Orig1s039,205879Orig1s017ltr.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\\\/204353s036,205879s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"01\/27\/2020","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204353s033,205879s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","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\\\/204353s031lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204353Orig1s031,205879Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/29\/2018","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204353s025,205879s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204353Orig1s025,205879Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"08\/11\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204353s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204353Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204353s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204353Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"08\/17\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204353Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"11\/23\/2016","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/20\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s006s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204353Orig1s006,s015ltr.pdf\"}]","notes":">"},{"actionDate":"02\/01\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204353s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204353Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"12\/04\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204353s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204353Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"04\/14\/2016","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/28\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204353Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"03\/17\/2016","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/23\/2015","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/20\/2016","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204353s006s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204353Orig1s006,s015ltr.pdf\"}]","notes":">"},{"actionDate":"06\/08\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/10\/2015","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204353s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204353Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204353s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204353Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-08-18
)
)