Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Discontinued | 005 |
Prescription | 007 |
Prescription | 008 |
Application Products
001 | TABLET;ORAL | 1MG | 1 | RISPERDAL | RISPERIDONE |
002 | TABLET;ORAL | 2MG | 1 | RISPERDAL | RISPERIDONE |
003 | TABLET;ORAL | 3MG | 1 | RISPERDAL | RISPERIDONE |
004 | TABLET;ORAL | 4MG | 1 | RISPERDAL | RISPERIDONE |
005 | TABLET;ORAL | 5MG | 0 | RISPERDAL | RISPERIDONE |
007 | TABLET;ORAL | 0.5MG | 1 | RISPERDAL | RISPERIDONE |
008 | TABLET;ORAL | 0.25MG | 1 | RISPERDAL | RISPERIDONE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-12-29 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-12-22 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 1995-04-12 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 1996-02-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-03-07 | PRIORITY |
LABELING; Labeling | SUPPL | 6 | AP | 1998-04-02 | STANDARD |
EFFICACY; Efficacy | SUPPL | 7 | AP | 1997-10-17 | STANDARD |
EFFICACY; Efficacy | SUPPL | 8 | AP | 2002-03-03 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 1999-07-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-05-13 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-10-26 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1999-01-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1999-05-10 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1999-10-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-07-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-10-22 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2001-09-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-07-09 | PRIORITY |
LABELING; Labeling | SUPPL | 24 | AP | 2002-11-19 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2003-10-29 | STANDARD |
EFFICACY; Efficacy | SUPPL | 26 | AP | 2003-12-04 | STANDARD |
EFFICACY; Efficacy | SUPPL | 27 | AP | 2003-12-04 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2003-09-10 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2003-11-21 | STANDARD |
EFFICACY; Efficacy | SUPPL | 36 | AP | 2006-10-06 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 41 | AP | 2006-10-06 | PRIORITY |
LABELING; Labeling | SUPPL | 42 | AP | 2005-08-17 | STANDARD |
EFFICACY; Efficacy | SUPPL | 46 | AP | 2007-08-22 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 47 | AP | 2007-08-22 | PRIORITY |
LABELING; Labeling | SUPPL | 54 | AP | 2008-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 55 | AP | 2010-08-30 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 2009-07-19 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 58 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 59 | AP | 2011-08-24 | STANDARD |
LABELING; Labeling | SUPPL | 60 | AP | 2011-09-24 | PRIORITY |
LABELING; Labeling | SUPPL | 61 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 62 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 63 | AP | 2010-12-01 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 64 | AP | 2011-06-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 65 | AP | 2012-08-02 | STANDARD |
LABELING; Labeling | SUPPL | 66 | AP | 2011-09-24 | STANDARD |
LABELING; Labeling | SUPPL | 67 | AP | 2012-03-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 71 | AP | 2013-02-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 2013-06-13 | PRIORITY |
LABELING; Labeling | SUPPL | 73 | AP | 2014-04-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 2016-02-09 | PRIORITY |
LABELING; Labeling | SUPPL | 77 | AP | 2016-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 78 | AP | 2017-02-23 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 80 | AP | 2018-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 82 | AP | 2019-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 83 | AP | 2021-02-12 | STANDARD |
LABELING; Labeling | SUPPL | 85 | AP | 2020-02-05 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 87 | AP | 2022-12-02 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 41 | Null | 0 |
SUPPL | 46 | Null | 8 |
SUPPL | 47 | Null | 6 |
SUPPL | 55 | Null | 6 |
SUPPL | 58 | Null | 7 |
SUPPL | 59 | Null | 7 |
SUPPL | 60 | Null | 0 |
SUPPL | 61 | Null | 6 |
SUPPL | 62 | Null | 6 |
SUPPL | 63 | Null | 6 |
SUPPL | 64 | Null | 6 |
SUPPL | 65 | Null | 6 |
SUPPL | 66 | Null | 7 |
SUPPL | 67 | Null | 7 |
SUPPL | 71 | Null | 0 |
SUPPL | 72 | Null | 0 |
SUPPL | 73 | Null | 15 |
SUPPL | 76 | Null | 0 |
SUPPL | 77 | Null | 15 |
SUPPL | 78 | Null | 6 |
SUPPL | 80 | Null | 6 |
SUPPL | 82 | Null | 15 |
SUPPL | 83 | Null | 6 |
SUPPL | 85 | Null | 7 |
SUPPL | 87 | Null | 6 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
007 | Prescription | AB |
008 | Prescription | AB |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20272
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/12\/2021","submission":"SUPPL-83","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-85","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-82","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-80","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020272s080,020588s068,021444s054lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-78","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020272s078,020588s066,021444s052lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2016","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020272s077,020588s065,021346s055,021444s051lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2014","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020272s073,020588s062,021444s048lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2012","submission":"SUPPL-65","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-66","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-60","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-59","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-64","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-63","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-62","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020272S-055S-058S-061S-062lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-61","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020272S-055S-058S-061S-062lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020272S-055S-058S-061S-062lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020272S-055S-058S-061S-062lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2009","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020272s056,020588s044,021346s033,021444s03lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2007","submission":"SUPPL-47","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":"08\/22\/2007","submission":"SUPPL-46","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-41","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-36","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-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020272s042,020588s030,021444s016,021346s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2003","submission":"SUPPL-27","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2003","submission":"SUPPL-26","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/1999","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20588s05lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL","submission":"RISPERIDONE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-02-12
)
)