Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
Application Products
001 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 273MG/0.875ML (273MG/0.875ML) | 1 | INVEGA TRINZA | PALIPERIDONE PALMITATE |
002 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 410MG/1.315ML (311.79MG/ML) | 1 | INVEGA TRINZA | PALIPERIDONE PALMITATE |
003 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 546MG/1.75ML (312MG/ML) | 1 | INVEGA TRINZA | PALIPERIDONE PALMITATE |
004 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 819MG/2.625ML (312MG/ML) | 1 | INVEGA TRINZA | PALIPERIDONE PALMITATE |
005 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 1,092MG/3.5ML | 2 | INVEGA HAFYERA | PALIPERIDONE PALMITATE |
006 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 1,560MG/5ML | 2 | INVEGA HAFYERA | PALIPERIDONE PALMITATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2015-05-18 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 2017-02-23 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 6 | AP | 2018-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2019-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2021-02-12 | STANDARD |
EFFICACY; Efficacy | SUPPL | 10 | AP | 2021-08-30 | STANDARD |
LABELING; Labeling | SUPPL | 11 | TA | 2021-02-10 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 6 |
SUPPL | 3 | Null | 15 |
SUPPL | 6 | Null | 6 |
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 11 | Null | 15 |
TE Codes
005 | Prescription | TBD |
006 | Prescription | TBD |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 207946
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"INVEGA HAFYERA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"1.092GM\/3.5ML (312MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVEGA HAFYERA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"1.560GM\/5ML (312MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVEGA TRINZA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"273MG\/0.875ML (273MG\/0.875ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVEGA TRINZA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"410MG\/1.315ML (311.79MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVEGA TRINZA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"546MG\/1.75ML (312MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVEGA TRINZA","activeIngredients":"PALIPERIDONE PALMITATE","strength":"819MG\/2.625ML (312MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/30\/2021","submission":"SUPPL-10","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207946Orig1s010lbl.pdf\"}]","notes":"Label for INVEGA HAFYERA"},{"actionDate":"08\/09\/2021","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207946Orig1s011lbl.pdf\"}]","notes":"Label for INVEGA TRINZA"},{"actionDate":"02\/12\/2021","submission":"SUPPL-9","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-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207946s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207946s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207946s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207946s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207946s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/18\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207946s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207946Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207946Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207946Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/09\/2021","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207946Orig1s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207946Orig1s011ltr.pdf\"}]","notes":"> Label for INVEGA TRINZA"},{"actionDate":"08\/30\/2021","submission":"SUPPL-10","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207946Orig1s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207946Orig1s010ltr.pdf\"}]","notes":"> Label for INVEGA HAFYERA"},{"actionDate":"02\/12\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"01\/25\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207946s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/021999Orig1s036,022264Orig1s029,207946Orig1s008Ltr.pdf\"}]","notes":">"},{"actionDate":"07\/27\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207946s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"02\/23\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207946s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"03\/01\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207946s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2021-08-30
)
)