Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 1MG/ML | 1 | RISPERDAL | RISPERIDONE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1996-06-10 | STANDARD |
EFFICACY; Efficacy | SUPPL | 2 | AP | 1997-10-17 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-04-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 4 | AP | 2002-03-03 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 1999-07-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-05-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-06-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-10-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2002-11-19 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2003-10-29 | STANDARD |
EFFICACY; Efficacy | SUPPL | 17 | AP | 2003-12-04 | STANDARD |
EFFICACY; Efficacy | SUPPL | 18 | AP | 2003-12-04 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2003-09-10 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2003-11-21 | STANDARD |
EFFICACY; Efficacy | SUPPL | 24 | AP | 2006-10-06 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 28 | AP | 2006-10-06 | STANDARD |
EFFICACY; Efficacy | SUPPL | 29 | AP | 2006-10-06 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2005-08-17 | STANDARD |
EFFICACY; Efficacy | SUPPL | 36 | AP | 2007-08-22 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 37 | AP | 2007-08-22 | PRIORITY |
LABELING; Labeling | SUPPL | 42 | AP | 2008-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 43 | AP | 2010-08-30 | STANDARD |
LABELING; Labeling | SUPPL | 44 | AP | 2009-07-19 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 46 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 47 | AP | 2011-08-24 | STANDARD |
LABELING; Labeling | SUPPL | 48 | AP | 2011-09-24 | STANDARD |
LABELING; Labeling | SUPPL | 49 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 50 | AP | 2010-08-30 | UNKNOWN |
LABELING; Labeling | SUPPL | 51 | AP | 2010-12-01 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 52 | AP | 2011-06-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 53 | AP | 2012-08-02 | STANDARD |
LABELING; Labeling | SUPPL | 54 | AP | 2011-09-24 | STANDARD |
LABELING; Labeling | SUPPL | 55 | AP | 2012-03-12 | STANDARD |
LABELING; Labeling | SUPPL | 62 | AP | 2014-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 65 | AP | 2016-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 66 | AP | 2017-02-23 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 68 | AP | 2018-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 70 | AP | 2019-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 71 | AP | 2021-02-12 | STANDARD |
LABELING; Labeling | SUPPL | 72 | AP | 2020-02-05 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 73 | AP | 2022-03-11 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 36 | Null | 6 |
SUPPL | 37 | Null | 6 |
SUPPL | 43 | Null | 7 |
SUPPL | 46 | Null | 6 |
SUPPL | 47 | Null | 6 |
SUPPL | 48 | Null | 0 |
SUPPL | 49 | Null | 6 |
SUPPL | 50 | Null | 6 |
SUPPL | 51 | Null | 6 |
SUPPL | 52 | Null | 6 |
SUPPL | 53 | Null | 6 |
SUPPL | 54 | Null | 6 |
SUPPL | 55 | Null | 7 |
SUPPL | 62 | Null | 6 |
SUPPL | 65 | Null | 7 |
SUPPL | 66 | Null | 7 |
SUPPL | 68 | Null | 7 |
SUPPL | 70 | Null | 7 |
SUPPL | 71 | Null | 7 |
SUPPL | 72 | Null | 7 |
SUPPL | 73 | Null | 6 |
TE Codes
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20588
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
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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-53","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-54","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-48","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-47","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-52","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-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020588S-043S-046S-049S-050lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-43","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020588S-043S-046S-049S-050lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2009","submission":"SUPPL-44","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-37","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-36","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-29","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-28","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-24","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-30","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-18","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-17","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-5","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\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-02-12
)
)