Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Application Products
001 | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG | 1 | RISPERDAL | RISPERIDONE |
002 | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG | 1 | RISPERDAL | RISPERIDONE |
003 | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG | 1 | RISPERDAL | RISPERIDONE |
004 | TABLET, ORALLY DISINTEGRATING;ORAL | 3MG | 1 | RISPERDAL | RISPERIDONE |
005 | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | 1 | RISPERDAL | RISPERIDONE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-04-02 | STANDARD |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2003-12-04 | STANDARD |
EFFICACY; Efficacy | SUPPL | 3 | AP | 2003-12-04 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2003-09-10 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2003-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2003-11-21 | STANDARD |
EFFICACY; Efficacy | SUPPL | 8 | AP | 2006-10-06 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2004-12-23 | STANDARD |
EFFICACY; Efficacy | SUPPL | 15 | AP | 2006-10-06 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2005-08-17 | STANDARD |
EFFICACY; Efficacy | SUPPL | 20 | AP | 2007-08-22 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 21 | AP | 2007-08-22 | PRIORITY |
LABELING; Labeling | SUPPL | 29 | AP | 2008-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2010-08-30 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2009-07-19 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 33 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 34 | AP | 2011-08-24 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2011-09-24 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 37 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 39 | AP | 2010-12-01 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 40 | AP | 2011-06-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 41 | AP | 2012-08-02 | STANDARD |
LABELING; Labeling | SUPPL | 42 | AP | 2011-09-24 | STANDARD |
LABELING; Labeling | SUPPL | 43 | AP | 2012-03-12 | STANDARD |
LABELING; Labeling | SUPPL | 48 | AP | 2014-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 51 | AP | 2016-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 52 | AP | 2017-02-23 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 54 | AP | 2018-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 2019-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 57 | AP | 2021-02-12 | STANDARD |
LABELING; Labeling | SUPPL | 58 | AP | 2020-02-05 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 59 | AP | 2022-12-02 | STANDARD |
Submissions Property Types
SUPPL | 12 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 20 | Null | 8 |
SUPPL | 21 | Null | 8 |
SUPPL | 30 | Null | 7 |
SUPPL | 33 | Null | 6 |
SUPPL | 34 | Null | 6 |
SUPPL | 35 | Null | 0 |
SUPPL | 36 | Null | 6 |
SUPPL | 37 | Null | 6 |
SUPPL | 39 | Null | 6 |
SUPPL | 40 | Null | 6 |
SUPPL | 41 | Null | 6 |
SUPPL | 42 | Null | 6 |
SUPPL | 43 | Null | 7 |
SUPPL | 48 | Null | 7 |
SUPPL | 51 | Null | 6 |
SUPPL | 52 | Null | 6 |
SUPPL | 54 | Null | 6 |
SUPPL | 56 | Null | 31 |
SUPPL | 57 | Null | 6 |
SUPPL | 58 | Null | 15 |
SUPPL | 59 | Null | 6 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21444
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
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[labels] => [{"actionDate":"02\/12\/2021","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020272Orig1s083,020588Orig1s071,021444Orig1s057,021346Orig1s061lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2020","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020272s085,020588s072,021444s058lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2019","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020272s082,020588s070,021444s056lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"SUPPL-54","supplementCategories":"Labeling-Package 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020272s073,020588s062,021444s048lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2012","submission":"SUPPL-41","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020272s065,020588s053,021444s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2011","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020272s060s066,020588s048s054,021444s035s042lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2011","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020272s060s066,020588s048s054,021444s035s042lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2011","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020272s059,020588s047,021444s034lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2011","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020272s064,020588s052,021444s040lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020272s063,020588s051,021346s040,021444s039lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021444S-030S-033S-036S-037lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021444S-030S-033S-036S-037lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020272s46s47,20588s36s37,21444s20s21lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2007","submission":"SUPPL-20","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020272s46s47,20588s36s37,21444s20s21lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2006","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2006","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020272s042,020588s030,021444s016,021346s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2004","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21444s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2003","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label 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[originalApprovals] => [{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"1MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"3MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"4MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-02-12
)
)