Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 50MG;500MG | 1 | INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
002 | TABLET, EXTENDED RELEASE;ORAL | 50MG;1GM | 1 | INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
003 | TABLET, EXTENDED RELEASE;ORAL | 150MG;500MG | 1 | INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
004 | TABLET, EXTENDED RELEASE;ORAL | 150MG;1GM | 1 | INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2016-09-20 | STANDARD |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2018-01-02 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2017-07-25 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 6 | AP | 2017-08-11 | STANDARD |
EFFICACY; Efficacy | SUPPL | 7 | AP | 2018-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2018-10-26 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 11 | AP | 2020-01-27 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2020-01-24 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 17 | AP | 2020-08-18 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 6 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 6 |
SUPPL | 9 | Null | 6 |
SUPPL | 11 | Null | 15 |
SUPPL | 14 | Null | 7 |
SUPPL | 17 | Null | 6 |
SUPPL | 18 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 205879
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/204353s039,205879s017lbl.pdf#page=58"]
[products] => [{"drugName":"INVOKAMET XR","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"50MG;500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVOKAMET XR","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"50MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVOKAMET XR","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"150MG;500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVOKAMET XR","activeIngredients":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"150MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/18\/2020","submission":"SUPPL-17","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-11","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-14","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-7","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-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205879s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/02\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205879s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205879s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205879s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205879s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/20\/2016","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\\\/2016\\\/205879s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205879Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/205879Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/18\/2020","submission":"SUPPL-17","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-14","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-11","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\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204353Orig1s033,%20205879Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205879s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204353Orig1s031,205879Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/29\/2018","submission":"SUPPL-7","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-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205879s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205879Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205879s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205879Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/02\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205879s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205879s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-08-18
)
)