JANSSEN PHARMS FDA Approval NDA 020588

Application #020588

Documents

Letter	1999-07-02
Letter	2002-11-19
Letter	2003-11-28
Letter	2003-12-11
Letter	2003-12-11
Letter	2003-11-25
Letter	2006-10-18
Letter	2007-08-22
Letter	2010-09-07
Letter	2009-08-06
Letter	2010-09-07
Letter	2011-08-26
Letter	2010-09-07
Letter	2012-08-03
Letter	2011-09-28
Letter	2014-05-09
Label	2003-12-11
Label	2006-10-11
Label	2007-08-23
Label	2007-08-23
Label	2009-08-06
Label	2011-08-25
Label	2010-08-30
Label	2010-12-04
Label	2011-09-30
Label	2014-04-29
Review	1997-10-17
Review	2009-09-16
Review	2011-12-14
Other Important Information from FDA	2011-12-20
Letter	2002-03-03
Letter	2003-09-25
Letter	2006-10-18
Letter	2006-10-18
Letter	2005-08-19
Letter	2007-08-22
Letter	2008-08-19
Letter	2011-09-28
Letter	2010-09-07
Letter	2010-12-06
Letter	2011-06-17
Letter	2012-03-13
Letter	2016-03-03
Label	1999-07-02
Label	2003-12-11
Label	2006-10-11
Label	2006-10-11
Label	2005-08-19
Label	2010-08-30
Label	2010-08-30
Label	2011-09-30
Label	2010-08-30
Label	2011-06-16
Label	2012-08-03
Label	2016-03-03
Review	2008-02-19
Review	2013-06-03
Review	2013-06-03
Review	2011-12-14
Other	2004-11-02
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
Letter	2022-03-14
Label	2022-03-15

Application Sponsors

NDA 020588

JANSSEN PHARMS

Marketing Status

Prescription

001

Application Products

001

SOLUTION;ORAL

1MG/ML

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

001

Prescription

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"}]
            [labels] => [{"actionDate":"02\/12\/2021","submission":"SUPPL-71","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-72","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-70","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-68","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-66","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-65","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-62","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-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 (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020272s063,020588s051,021346s040,021444s039lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020588S-043S-046S-049S-050lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020588S-043S-046S-049S-050lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (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
        )

)

NDA 020588

JANSSEN PHARMS

FDA Drug Application

Application #020588

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

JANSSEN PHARMS