Application 020272

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERDAL	RISPERIDONE	TABLET;ORAL	1MG	Yes	Yes
002	RISPERDAL	RISPERIDONE	TABLET;ORAL	2MG	Yes	No
003	RISPERDAL	RISPERIDONE	TABLET;ORAL	3MG	Yes	No
004	RISPERDAL	RISPERIDONE	TABLET;ORAL	4MG	Yes	No
005	RISPERDAL	RISPERIDONE	TABLET;ORAL	5MG	No	No
007	RISPERDAL	RISPERIDONE	TABLET;ORAL	0.5MG	Yes	No
008	RISPERDAL	RISPERIDONE	TABLET;ORAL	0.25MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-113	RISPERDAL	risperidone	Rebel Distributors Corp	NDA	Current
21695-115	RISPERDAL	risperidone	Rebel Distributors Corp	NDA	Current
43353-412	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-432	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-720	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-300	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-301	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-302	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-320	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-330	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-350	RISPERDAL	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-590	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-590	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-590	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-591	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-591	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-591	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-592	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-592	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-592	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-593	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-593	Risperidone	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83887	SUPPL	2025-10-23
83886	SUPPL	2025-10-23
81130	SUPPL	2025-02-07
81030	SUPPL	2025-02-05
72791	SUPPL	2022-12-05
72783	SUPPL	2022-12-05
66281	SUPPL	2021-02-18
66239	SUPPL	2021-02-17
61842	SUPPL	2020-02-07
61785	SUPPL	2020-02-06
57553	SUPPL	2019-02-13
57360	SUPPL	2019-01-28
55144	SUPPL	2018-08-09
55050	SUPPL	2018-07-30
47420	SUPPL	2017-03-02
47320	SUPPL	2017-02-24
34460	SUPPL	2016-03-03
24714	SUPPL	2016-03-03
24713	SUPPL	2014-05-09
34459	SUPPL	2014-04-29
41261	SUPPL	2013-06-03
41260	SUPPL	2013-06-03
24710	SUPPL	2012-08-03
12408	SUPPL	2012-08-03
24712	SUPPL	2012-03-13
44053	ORIG	2011-12-20
41262	SUPPL	2011-12-14
20581	SUPPL	2011-12-14
34458	SUPPL	2011-09-30
34455	SUPPL	2011-09-30
24711	SUPPL	2011-09-28
24707	SUPPL	2011-09-28
24706	SUPPL	2011-08-26
12405	SUPPL	2011-08-25
24709	SUPPL	2011-06-17
12407	SUPPL	2011-06-16
41255	ORIG	2011-02-15
2282	SUPPL	2010-12-06
12406	SUPPL	2010-12-04
24708	SUPPL	2010-09-07
24705	SUPPL	2010-09-07
2281	SUPPL	2010-09-07
2279	SUPPL	2010-09-07
34457	SUPPL	2010-08-30
34456	SUPPL	2010-08-30
12404	SUPPL	2010-08-30
12402	SUPPL	2010-08-30
41259	SUPPL	2009-09-16
20579	SUPPL	2009-09-16
12403	SUPPL	2009-08-06
2280	SUPPL	2009-08-06
41258	SUPPL	2009-01-12
2278	SUPPL	2008-08-19
20580	SUPPL	2008-02-19
12401	SUPPL	2007-08-23
12400	SUPPL	2007-08-23
24704	SUPPL	2007-08-22
2277	SUPPL	2007-08-22
41256	SUPPL	2007-07-20
20578	SUPPL	2007-07-20
24702	SUPPL	2006-10-18
24701	SUPPL	2006-10-18
12398	SUPPL	2006-10-11
12397	SUPPL	2006-10-11
24703	SUPPL	2005-08-19
12399	SUPPL	2005-08-19
23969	SUPPL	2004-11-03
24700	SUPPL	2004-06-16
12395	SUPPL	2004-06-16
2273	SUPPL	2004-06-16
34454	SUPPL	2003-12-11
24699	SUPPL	2003-12-11
12396	SUPPL	2003-12-11
2275	SUPPL	2003-12-11
24698	SUPPL	2003-11-28
2276	SUPPL	2003-11-25
2274	SUPPL	2002-11-19
24697	SUPPL	2002-03-03
41257	SUPPL	1997-10-17
52165	SUPPL	1900-01-01
52164	SUPPL	1900-01-01
52163	SUPPL	1900-01-01
52162	SUPPL	1900-01-01
52161	SUPPL	1900-01-01
51647	ORIG	1900-01-01
51646	ORIG	1900-01-01
51645	ORIG	1900-01-01
51644	ORIG	1900-01-01
51643	ORIG	1900-01-01

Application 020272

Related Records#

Application Products#

NDC Listings For This Application#

Documents#