JANSSEN PHARMS FDA Approval NDA 204353

NDA 204353

JANSSEN PHARMS

FDA Drug Application

Application #204353

Documents

Letter2014-08-11
Letter2015-03-04
Letter2016-05-24
Letter2016-03-30
Letter2015-12-08
Label2014-08-12
Label2015-09-11
Label2016-03-30
Review2014-09-03
Letter2015-09-14
Letter2016-05-24
Label2015-03-20
Label2016-05-23
Label2015-12-08
Label2016-05-23
Summary Review2014-09-03
Letter2016-08-17
Label2016-08-22
Letter2017-02-01
Label2017-02-01
Label2017-07-25
Letter2017-07-28
Label2017-08-14
Letter2017-08-21
Letter2018-10-30
Label2018-10-30
Label2018-10-31
Letter2018-10-31
Label2020-01-27
Letter2020-01-27
Letter2020-01-28
Label2020-01-28
Medication Guide2020-01-28
Letter2020-08-19
Label2020-08-19
Medication Guide2020-08-19
Letter2022-10-14
Medication Guide2022-10-17
Label2022-10-17

Application Sponsors

NDA 204353JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL50MG;500MG1INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
002TABLET;ORAL50MG;1GM1INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
003TABLET;ORAL150MG;500MG1INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
004TABLET;ORAL150MG;1GM1INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2014-08-08STANDARD
LABELING; LabelingSUPPL2AP2015-03-03STANDARD
EFFICACY; EfficacySUPPL3AP2015-09-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2015-06-08STANDARD
EFFICACY; EfficacySUPPL6AP2016-05-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2015-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2016-03-17STANDARD
LABELING; LabelingSUPPL10AP2016-03-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2016-04-14STANDARD
LABELING; LabelingSUPPL12AP2015-12-04901 REQUIRED
EFFICACY; EfficacySUPPL14AP2017-02-01STANDARD
LABELING; LabelingSUPPL15AP2016-05-20901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2016-11-23STANDARD
LABELING; LabelingSUPPL20AP2016-08-17901 REQUIRED
LABELING; LabelingSUPPL23AP2017-07-25901 REQUIRED
LABELING; LabelingSUPPL24AP2017-08-11STANDARD
EFFICACY; EfficacySUPPL25AP2018-10-29STANDARD
LABELING; LabelingSUPPL31AP2018-10-26901 REQUIRED
EFFICACY; EfficacySUPPL33AP2020-01-27STANDARD
LABELING; LabelingSUPPL36AP2020-01-24901 REQUIRED
EFFICACY; EfficacySUPPL39AP2020-08-18STANDARD
LABELING; LabelingSUPPL41AP2022-10-13901 REQUIRED

Submissions Property Types

ORIG1Null7
SUPPL2Null6
SUPPL3Null7
SUPPL4Null0
SUPPL6Null7
SUPPL7Null0
SUPPL8Null0
SUPPL10Null15
SUPPL11Null0
SUPPL12Null6
SUPPL14Null6
SUPPL15Null6
SUPPL20Null7
SUPPL23Null15
SUPPL24Null6
SUPPL25Null6
SUPPL31Null15
SUPPL33Null7
SUPPL36Null6
SUPPL39Null15
SUPPL41Null7

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
        )

)
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