JANSSEN PHARMS FDA Approval NDA 022264

NDA 022264

JANSSEN PHARMS

FDA Drug Application

Application #022264

Documents

Letter2009-08-17
Letter2010-05-18
Letter2011-06-24
Letter2010-12-07
Letter2015-06-10
Letter2016-03-03
Label2009-10-01
Label2014-05-02
Label2014-12-20
Label2015-06-11
Label2016-03-03
Letter2012-08-30
Letter2011-09-28
Letter2014-05-01
Letter2014-11-14
Letter2014-11-14
Label2010-05-17
Label2011-06-16
Label2010-12-04
Label2012-08-31
Label2011-09-30
Label2014-12-20
Review2010-05-13
Other Important Information from FDA2011-12-22
Summary Review2010-05-13
Label2017-02-24
Letter2017-03-02
Label2017-06-16
Letter2017-06-16
Label2017-12-26
Letter2017-12-27
Letter2018-07-30
Label2018-09-21
Label2019-01-28
Letter2019-02-13
Review2020-05-08
Letter2021-02-17
Label2021-02-17
Letter2021-08-10
Label2021-08-11
Letter2022-08-01
Label2022-08-10

Application Sponsors

NDA 022264JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR39MG/0.25ML (39MG/0.25ML)1INVEGA SUSTENNAPALIPERIDONE PALMITATE
002SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR78MG/0.5ML (78MG/0.5ML)1INVEGA SUSTENNAPALIPERIDONE PALMITATE
003SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR117MG/0.75ML (117MG/0.75ML)1INVEGA SUSTENNAPALIPERIDONE PALMITATE
004SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR156MG/ML (156MG/ML)1INVEGA SUSTENNAPALIPERIDONE PALMITATE
005SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR234MG/1.5ML (156MG/ML)1INVEGA SUSTENNAPALIPERIDONE PALMITATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2009-07-31STANDARD
LABELING; LabelingSUPPL2AP2011-06-15STANDARD
LABELING; LabelingSUPPL4AP2010-12-01901 REQUIRED
EFFICACY; EfficacySUPPL5AP2012-08-29STANDARD
LABELING; LabelingSUPPL6AP2011-09-24STANDARD
LABELING; LabelingSUPPL10AP2014-04-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2013-08-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2014-08-25STANDARD
EFFICACY; EfficacySUPPL13AP2014-11-12PRIORITY
EFFICACY; EfficacySUPPL14AP2014-11-12PRIORITY
EFFICACY; EfficacySUPPL15AP2017-12-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2015-06-16STANDARD
LABELING; LabelingSUPPL18AP2015-06-09STANDARD
LABELING; LabelingSUPPL19AP2016-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2016-11-16STANDARD
LABELING; LabelingSUPPL23AP2017-06-15STANDARD
LABELING; LabelingSUPPL24AP2017-02-23901 REQUIRED
LABELING; LabelingSUPPL27AP2018-07-27STANDARD
LABELING; LabelingSUPPL29AP2019-01-25STANDARD
LABELING; LabelingSUPPL30AP2021-02-12STANDARD
LABELING; LabelingSUPPL33TA2021-02-10STANDARD
LABELING; LabelingSUPPL34AP2022-07-29STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null6
SUPPL4Null7
SUPPL5Null15
SUPPL6Null6
SUPPL10Null6
SUPPL11Null0
SUPPL12Null0
SUPPL13Null15
SUPPL14Null15
SUPPL15Null6
SUPPL17Null0
SUPPL18Null15
SUPPL19Null6
SUPPL23Null6
SUPPL24Null7
SUPPL27Null6
SUPPL29Null15
SUPPL30Null6
SUPPL33Null15
SUPPL34Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP
005PrescriptionAP

CDER Filings

JANSSEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22264
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"INVEGA SUSTENNA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"39MG\/0.25ML (39MG\/0.25ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"INVEGA SUSTENNA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"78MG\/0.5ML (78MG\/0.5ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"INVEGA SUSTENNA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"117MG\/0.75ML (117MG\/0.75ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"INVEGA SUSTENNA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"156MG\/ML (156MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"INVEGA SUSTENNA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"234MG\/1.5ML (156MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/09\/2021","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022264Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2021","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022264s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022264s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2017","submission":"SUPPL-15","supplementCategories":"Efficacy-Accelerated Approval Confirmatory Study","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022264s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022264s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022264s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022264s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022264s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2014","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022264s013s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2014","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022264s013s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022264s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2012","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022264s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2011","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022264s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022264s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022264s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2010","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022264s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022264lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INVEGA SUSTENNA","submission":"PALIPERIDONE PALMITATE","actionType":"39MG\/0.25ML (39MG\/0.25ML)","submissionClassification":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA SUSTENNA","submission":"PALIPERIDONE PALMITATE","actionType":"78MG\/0.5ML (78MG\/0.5ML)","submissionClassification":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA SUSTENNA","submission":"PALIPERIDONE PALMITATE","actionType":"117MG\/0.75ML (117MG\/0.75ML)","submissionClassification":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA SUSTENNA","submission":"PALIPERIDONE PALMITATE","actionType":"156MG\/ML (156MG\/ML)","submissionClassification":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA SUSTENNA","submission":"PALIPERIDONE PALMITATE","actionType":"234MG\/1.5ML (156MG\/ML)","submissionClassification":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-08-09
        )

)
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