JANSSEN PHARMS FDA Approval NDA 205879

NDA 205879

JANSSEN PHARMS

FDA Drug Application

Application #205879

Documents

Letter2016-09-29
Label2016-09-29
Label2017-07-25
Letter2017-07-28
Label2017-08-14
Letter2017-08-21
Review2017-11-28
Label2018-01-03
Letter2018-01-03
Letter2018-10-30
Label2018-10-30
Label2018-10-31
Letter2018-10-31
Label2020-01-27
Letter2020-01-27
Letter2020-01-28
Medication Guide2020-01-28
Label2020-01-28
Letter2020-08-19
Label2020-08-19
Medication Guide2020-08-19
Letter2022-10-14
Label2022-10-17
Medication Guide2022-10-17

Application Sponsors

NDA 205879JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL50MG;500MG1INVOKAMET XRCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL50MG;1GM1INVOKAMET XRCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL150MG;500MG1INVOKAMET XRCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL150MG;1GM1INVOKAMET XRCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2016-09-20STANDARD
EFFICACY; EfficacySUPPL2AP2018-01-02STANDARD
LABELING; LabelingSUPPL5AP2017-07-25901 REQUIRED
LABELING; LabelingSUPPL6AP2017-08-11STANDARD
EFFICACY; EfficacySUPPL7AP2018-10-29STANDARD
LABELING; LabelingSUPPL9AP2018-10-26901 REQUIRED
EFFICACY; EfficacySUPPL11AP2020-01-27STANDARD
LABELING; LabelingSUPPL14AP2020-01-24901 REQUIRED
EFFICACY; EfficacySUPPL17AP2020-08-18STANDARD
LABELING; LabelingSUPPL18AP2022-10-13901 REQUIRED

Submissions Property Types

ORIG1Null7
SUPPL2Null6
SUPPL5Null15
SUPPL6Null15
SUPPL7Null6
SUPPL9Null6
SUPPL11Null15
SUPPL14Null7
SUPPL17Null6
SUPPL18Null6

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
        )

)
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