JANSSEN PHARMS FDA Approval NDA 204042

Application #204042

Documents

Letter	2014-05-20
Letter	2015-03-04
Letter	2016-05-24
Label	2015-09-11
Label	2015-12-08
Label	2016-05-23
Letter	2013-04-01
Letter	2016-03-30
Letter	2015-12-08
Letter	2016-05-24
Label	2013-04-01
Label	2014-05-19
Label	2015-03-05
Label	2016-03-30
Label	2016-05-23
Review	2013-05-10
Label	2016-08-22
Letter	2016-08-17
Letter	2017-02-01
Label	2017-02-01
Label	2017-07-25
Letter	2017-07-28
Review	2018-02-27
Letter	2018-10-30
Label	2018-10-30
Label	2018-10-31
Letter	2018-10-31
Letter	2019-09-30
Label	2019-09-30
Review	2019-10-10
Medication Guide	2019-10-10
Summary Review	2013-04-01
Label	2020-01-27
Medication Guide	2020-01-27
Letter	2020-01-27
Review	2020-03-24
Letter	2020-08-19
Label	2020-08-19
Medication Guide	2020-08-19
Review	2021-09-24
Letter	2022-10-14
Label	2022-10-17
Medication Guide	2022-10-17

Application Sponsors

NDA 204042

JANSSEN PHARMS

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
        )

)

NDA 204042

JANSSEN PHARMS

FDA Drug Application

Application #204042

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

JANSSEN PHARMS