Application 021444

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-601	Risperidone M-TAB	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-602	Risperidone M-TAB	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-603	Risperidone M-TAB	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83892	SUPPL	2025-10-23
81129	SUPPL	2025-02-07
81033	SUPPL	2025-02-06
72792	SUPPL	2022-12-05
72784	SUPPL	2022-12-05
66283	SUPPL	2021-02-18
66241	SUPPL	2021-02-17
61845	SUPPL	2020-02-07
61787	SUPPL	2020-02-06
57555	SUPPL	2019-02-13
57362	SUPPL	2019-01-28
55146	SUPPL	2018-08-09
55052	SUPPL	2018-07-30
47422	SUPPL	2017-03-02
47318	SUPPL	2017-02-24
15486	SUPPL	2016-03-03
5398	SUPPL	2016-03-03
27806	SUPPL	2014-05-09
15485	SUPPL	2014-04-29
42171	SUPPL	2013-06-03
21660	SUPPL	2013-06-03
36946	SUPPL	2012-08-03
5395	SUPPL	2012-08-03
5397	SUPPL	2012-03-13
23661	ORIG	2011-12-20
42172	SUPPL	2011-12-14
21661	SUPPL	2011-12-14
36947	SUPPL	2011-09-30
15482	SUPPL	2011-09-30
27802	SUPPL	2011-09-28
5396	SUPPL	2011-09-28
27801	SUPPL	2011-08-26
15481	SUPPL	2011-08-25
27805	SUPPL	2011-06-17
36945	SUPPL	2011-06-16
27804	SUPPL	2010-12-06
15484	SUPPL	2010-12-04
27803	SUPPL	2010-09-07
5394	SUPPL	2010-09-07
5393	SUPPL	2010-09-07
5392	SUPPL	2010-09-07
36944	SUPPL	2010-08-30
36943	SUPPL	2010-08-30
36941	SUPPL	2010-08-30
15483	SUPPL	2010-08-30
27800	SUPPL	2009-08-06
36942	SUPPL	2009-07-21
27799	SUPPL	2008-08-19
42170	SUPPL	2008-02-19
36940	SUPPL	2007-08-23
15480	SUPPL	2007-08-23
27798	SUPPL	2007-08-22
5391	SUPPL	2007-08-22
27797	SUPPL	2006-10-18
5389	SUPPL	2006-10-18
15479	SUPPL	2006-10-11
15477	SUPPL	2006-10-11
36939	SUPPL	2005-08-19
5390	SUPPL	2005-08-19
15478	SUPPL	2004-12-29
5388	SUPPL	2004-12-29
36938	SUPPL	2003-12-11
27795	SUPPL	2003-12-11
15476	SUPPL	2003-12-11
5385	SUPPL	2003-12-11
5387	SUPPL	2003-11-28
27796	SUPPL	2003-11-25
5386	SUPPL	2003-09-25
42169	ORIG	2003-07-15
27794	ORIG	2003-05-29
36937	ORIG	2003-04-07

Application 021444

Related Records#

Application Products#

NDC Listings For This Application#

Documents#