NDA 020272

JANSSEN PHARMS

FDA Drug Application

Application #020272

Documents

• Letter: 2004-06-16
• Letter: 2002-11-19
• Letter: 2003-12-11
• Letter: 2003-11-25
• Letter: 2007-08-22
• Letter: 2008-08-19
• Letter: 2010-09-07
• Letter: 2009-08-06
• Letter: 2010-09-07
• Letter: 2010-12-06
• Label: 2004-06-16
• Label: 2003-12-11
• Label: 2006-10-11
• Label: 2006-10-11
• Label: 2005-08-19
• Label: 2007-08-23
• Label: 2007-08-23
• Label: 2010-08-30
• Label: 2009-08-06
• Label: 2010-08-30
• Label: 2011-08-25
• Label: 2010-12-04
• Label: 2011-06-16
• Label: 2012-08-03
• Review: 2007-07-20
• Review: 2009-09-16
• Review: 2008-02-19
• Review: 2011-12-14
• Other: 2004-11-03
• Letter: 2002-03-03
• Letter: 2003-11-28
• Letter: 2003-12-11
• Letter: 2004-06-16
• Letter: 2006-10-18
• Letter: 2006-10-18
• Letter: 2005-08-19
• Letter: 2007-08-22
• Letter: 2010-09-07
• Letter: 2011-08-26
• Letter: 2011-09-28
• Letter: 2010-09-07
• Letter: 2011-06-17
• Letter: 2012-08-03
• Letter: 2011-09-28
• Letter: 2012-03-13
• Letter: 2014-05-09
• Letter: 2016-03-03
• Label: 2003-12-11
• Label: 2011-09-30
• Label: 2010-08-30
• Label: 2010-08-30
• Label: 2011-09-30
• Label: 2014-04-29
• Label: 2016-03-03
• Review: 2011-02-15
• Review: 2007-07-20
• Review: 1997-10-17
• Review: 2009-01-12
• Review: 2009-09-16
• Review: 2013-06-03
• Review: 2013-06-03
• Review: 2011-12-14
• Other Important Information from FDA: 2011-12-20
• Label: 2017-02-24
• Letter: 2017-03-02
• Pediatric DD Summary Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• 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 020272

JANSSEN PHARMS

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
        )

)