JANSSEN PHARMS FDA Approval NDA 021999

NDA 021999

JANSSEN PHARMS

FDA Drug Application

Application #021999

Documents

Letter2008-01-09
Letter2008-09-05
Letter2008-08-19
Letter2009-08-06
Letter2009-07-23
Letter2011-02-18
Letter2011-04-11
Label2009-11-04
Label2009-08-04
Label2009-07-23
Label2011-02-24
Label2010-03-05
Label2010-12-04
Label2011-04-07
Label2016-03-03
Other Important Information from FDA2011-12-22
Letter2006-12-28
Letter2008-01-09
Letter2008-08-28
Letter2008-05-21
Letter2008-08-28
Letter2009-08-06
Letter2010-03-11
Letter2011-04-11
Letter2010-12-07
Letter2014-05-01
Letter2016-03-03
Label2006-12-28
Label2008-01-08
Label2008-08-29
Label2008-09-05
Label2008-08-29
Label2008-08-26
Label2009-08-04
Label2011-04-07
Label2014-05-02
Review2007-03-30
Review2014-08-05
Label2017-02-24
Letter2017-03-02
Label2017-08-18
Letter2017-08-21
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-07-30
Label2018-09-21
Label2019-01-28
Letter2019-02-13
Pediatric Written Request1900-01-01
Pediatric Amendment 11900-01-01
Pediatric Amendment 21900-01-01
Letter2021-02-17
Label2021-02-17
Label2022-04-11

Application Sponsors

NDA 021999JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Discontinued004
Prescription006

Application Products

001TABLET, EXTENDED RELEASE;ORAL3MG1INVEGAPALIPERIDONE
002TABLET, EXTENDED RELEASE;ORAL6MG1INVEGAPALIPERIDONE
003TABLET, EXTENDED RELEASE;ORAL9MG1INVEGAPALIPERIDONE
004TABLET, EXTENDED RELEASE;ORAL12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1INVEGAPALIPERIDONE
006TABLET, EXTENDED RELEASE;ORAL1.5MG1INVEGAPALIPERIDONE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2006-12-19STANDARD
LABELING; LabelingSUPPL2AP2007-12-21STANDARD
LABELING; LabelingSUPPL3AP2007-04-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2009-12-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2008-08-26N/A
LABELING; LabelingSUPPL6AP2008-09-04STANDARD
LABELING; LabelingSUPPL7AP2008-05-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2008-08-26STANDARD
LABELING; LabelingSUPPL10AP2008-08-14STANDARD
LABELING; LabelingSUPPL11AP2009-10-30STANDARD
EFFICACY; EfficacySUPPL13AP2009-07-31PRIORITY
EFFICACY; EfficacySUPPL14AP2009-07-31PRIORITY
LABELING; LabelingSUPPL15AP2009-07-19901 REQUIRED
LABELING; LabelingSUPPL17AP2011-02-16UNKNOWN
LABELING; LabelingSUPPL18AP2010-03-03UNKNOWN
LABELING; LabelingSUPPL20AP2011-04-06STANDARD
LABELING; LabelingSUPPL23AP2010-12-01901 REQUIRED
EFFICACY; EfficacySUPPL24AP2011-04-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2013-06-17STANDARD
LABELING; LabelingSUPPL29AP2014-04-29STANDARD
LABELING; LabelingSUPPL30AP2016-03-01STANDARD
LABELING; LabelingSUPPL32AP2017-02-23901 REQUIRED
LABELING; LabelingSUPPL34AP2017-08-11STANDARD
LABELING; LabelingSUPPL35AP2018-07-27STANDARD
LABELING; LabelingSUPPL36AP2019-01-25STANDARD
LABELING; LabelingSUPPL37AP2021-02-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2022-03-24STANDARD

Submissions Property Types

SUPPL4Null0
SUPPL8Null0
SUPPL11Null7
SUPPL13Null7
SUPPL14Null6
SUPPL17Null7
SUPPL18Null7
SUPPL20Null7
SUPPL23Null6
SUPPL24Null6
SUPPL28Null0
SUPPL29Null6
SUPPL30Null7
SUPPL32Null7
SUPPL34Null6
SUPPL35Null6
SUPPL36Null7
SUPPL37Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
006PrescriptionAB

CDER Filings

JANSSEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21999
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"INVEGA","activeIngredients":"PALIPERIDONE","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"INVEGA","activeIngredients":"PALIPERIDONE","strength":"6MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"INVEGA","activeIngredients":"PALIPERIDONE","strength":"9MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"INVEGA","activeIngredients":"PALIPERIDONE","strength":"12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"INVEGA","activeIngredients":"PALIPERIDONE","strength":"1.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/25\/2019","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021999s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021999s035lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2017","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021999s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021999s032lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2016","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021999s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021999s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2011","submission":"SUPPL-24","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021999s020s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021999s020s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2011","submission":"SUPPL-17","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021999s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021999s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2010","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021999s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2009","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021999s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021999s013s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021999s013s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2009","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021999s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2008","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021999s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2008","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021999s005s008lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/26\/2008","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021999s005s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2008","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021999s005s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2008","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021999s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2007","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021999s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021999lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INVEGA","submission":"PALIPERIDONE","actionType":"3MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA","submission":"PALIPERIDONE","actionType":"6MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA","submission":"PALIPERIDONE","actionType":"9MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA","submission":"PALIPERIDONE","actionType":"12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"INVEGA","submission":"PALIPERIDONE","actionType":"1.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-25
        )

)
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