Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Application Products
001 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 39MG/0.25ML (39MG/0.25ML) | 1 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE |
002 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 78MG/0.5ML (78MG/0.5ML) | 1 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE |
003 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 117MG/0.75ML (117MG/0.75ML) | 1 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE |
004 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 156MG/ML (156MG/ML) | 1 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE |
005 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 234MG/1.5ML (156MG/ML) | 1 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2009-07-31 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2011-06-15 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2010-12-01 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 5 | AP | 2012-08-29 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2011-09-24 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2014-04-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2013-08-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2014-08-25 | STANDARD |
EFFICACY; Efficacy | SUPPL | 13 | AP | 2014-11-12 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 14 | AP | 2014-11-12 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 15 | AP | 2017-12-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2015-06-16 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2015-06-09 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2016-03-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2016-11-16 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2017-06-15 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2017-02-23 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 27 | AP | 2018-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2019-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2021-02-12 | STANDARD |
LABELING; Labeling | SUPPL | 33 | TA | 2021-02-10 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2022-07-29 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 6 |
SUPPL | 2 | Null | 6 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 6 |
SUPPL | 10 | Null | 6 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 15 |
SUPPL | 14 | Null | 15 |
SUPPL | 15 | Null | 6 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 15 |
SUPPL | 19 | Null | 6 |
SUPPL | 23 | Null | 6 |
SUPPL | 24 | Null | 7 |
SUPPL | 27 | Null | 6 |
SUPPL | 29 | Null | 15 |
SUPPL | 30 | Null | 6 |
SUPPL | 33 | Null | 15 |
SUPPL | 34 | Null | 15 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
004 | Prescription | AP |
005 | Prescription | AP |
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
)
)