NDA 021444

JANSSEN PHARMS

FDA Drug Application

Application #021444

Documents

• Letter: 2003-12-11
• Letter: 2003-09-25
• Letter: 2003-11-28
• Letter: 2004-12-29
• Letter: 2006-10-18
• Letter: 2005-08-19
• Letter: 2007-08-22
• Letter: 2010-09-07
• Letter: 2010-09-07
• Letter: 2010-09-07
• Letter: 2012-08-03
• Letter: 2011-09-28
• Letter: 2012-03-13
• Letter: 2016-03-03
• Label: 2003-12-11
• Label: 2006-10-11
• Label: 2004-12-29
• Label: 2006-10-11
• Label: 2007-08-23
• Label: 2011-08-25
• Label: 2011-09-30
• Label: 2010-08-30
• Label: 2010-12-04
• Label: 2014-04-29
• Label: 2016-03-03
• Review: 2013-06-03
• Review: 2011-12-14
• Other Important Information from FDA: 2011-12-20
• Letter: 2003-05-29
• Letter: 2003-12-11
• Letter: 2003-11-25
• Letter: 2006-10-18
• Letter: 2007-08-22
• Letter: 2008-08-19
• Letter: 2009-08-06
• Letter: 2011-08-26
• Letter: 2011-09-28
• Letter: 2010-09-07
• Letter: 2010-12-06
• Letter: 2011-06-17
• Letter: 2014-05-09
• Label: 2003-04-07
• Label: 2003-12-11
• Label: 2005-08-19
• Label: 2007-08-23
• Label: 2010-08-30
• Label: 2009-07-21
• Label: 2010-08-30
• Label: 2010-08-30
• Label: 2011-06-16
• Label: 2012-08-03
• Label: 2011-09-30
• Review: 2003-07-15
• Review: 2008-02-19
• Review: 2013-06-03
• Review: 2011-12-14
• Label: 2017-02-24
• Letter: 2017-03-02
• Letter: 2018-07-30
• Label: 2018-08-09
• Label: 2019-01-28
• Letter: 2019-02-13
• Letter: 2020-02-06
• Label: 2020-02-07
• Letter: 2021-02-17
• Label: 2021-02-18
• Label: 2022-12-05
• Letter: 2022-12-05

Application Sponsors

NDA 021444

JANSSEN PHARMS

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] => ["",""]
            [products] => [{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"1MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"3MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL","activeIngredients":"RISPERIDONE","strength":"4MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [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 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-52","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-51","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-48","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-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 (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021444S-030S-033S-036S-037lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021444S-030S-033S-036S-037lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2009","submission":"SUPPL-31","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-21","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-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 (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-2","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":"04\/02\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021444lbl.pdf\"}]","notes":""}]
            [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
        )

)