Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Discontinued | 004 |
Prescription | 006 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 3MG | 1 | INVEGA | PALIPERIDONE |
002 | TABLET, EXTENDED RELEASE;ORAL | 6MG | 1 | INVEGA | PALIPERIDONE |
003 | TABLET, EXTENDED RELEASE;ORAL | 9MG | 1 | INVEGA | PALIPERIDONE |
004 | TABLET, EXTENDED RELEASE;ORAL | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | INVEGA | PALIPERIDONE |
006 | TABLET, EXTENDED RELEASE;ORAL | 1.5MG | 1 | INVEGA | PALIPERIDONE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2006-12-19 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2007-12-21 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2007-04-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2009-12-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2008-08-26 | N/A |
LABELING; Labeling | SUPPL | 6 | AP | 2008-09-04 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2008-05-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2008-08-26 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2008-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2009-10-30 | STANDARD |
EFFICACY; Efficacy | SUPPL | 13 | AP | 2009-07-31 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 14 | AP | 2009-07-31 | PRIORITY |
LABELING; Labeling | SUPPL | 15 | AP | 2009-07-19 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 17 | AP | 2011-02-16 | UNKNOWN |
LABELING; Labeling | SUPPL | 18 | AP | 2010-03-03 | UNKNOWN |
LABELING; Labeling | SUPPL | 20 | AP | 2011-04-06 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2010-12-01 | 901 REQUIRED |
EFFICACY; Efficacy | SUPPL | 24 | AP | 2011-04-06 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2013-06-17 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2014-04-29 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2016-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2017-02-23 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 34 | AP | 2017-08-11 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2018-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2019-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2021-02-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2022-03-24 | STANDARD |
Submissions Property Types
SUPPL | 4 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 11 | Null | 7 |
SUPPL | 13 | Null | 7 |
SUPPL | 14 | Null | 6 |
SUPPL | 17 | Null | 7 |
SUPPL | 18 | Null | 7 |
SUPPL | 20 | Null | 7 |
SUPPL | 23 | Null | 6 |
SUPPL | 24 | Null | 6 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 6 |
SUPPL | 30 | Null | 7 |
SUPPL | 32 | Null | 7 |
SUPPL | 34 | Null | 6 |
SUPPL | 35 | Null | 6 |
SUPPL | 36 | Null | 7 |
SUPPL | 37 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
006 | Prescription | AB |
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
)
)