NDA 207946

JANSSEN PHARMS

FDA Drug Application

Application #207946

Documents

• Letter: 2015-05-21
• Letter: 2016-03-03
• Label: 2015-05-20
• Review: 2016-02-08
• Label: 2016-03-03
• Summary Review: 2016-02-08
• Label: 2017-02-24
• Letter: 2017-03-02
• Letter: 2018-07-30
• Label: 2018-09-21
• Label: 2019-01-28
• Letter: 2019-02-13
• Letter: 2021-02-17
• Label: 2021-02-17
• Letter: 2021-08-10
• Label: 2021-08-11
• Letter: 2021-08-31
• Label: 2021-09-01

Application Sponsors

NDA 207946

JANSSEN PHARMS

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
        )

)