FDA.reportPublic FDA data

Application 020588

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RISPERDALRISPERIDONESOLUTION;ORAL1MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-305RISPERDALrisperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-596RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83888SUPPL 2025-10-23
81131SUPPL 2025-02-07
81031SUPPL 2025-02-05
70519SUPPL2022-03-15
70506SUPPL2022-03-14
66282SUPPL2021-02-18
66240SUPPL2021-02-17
61844SUPPL2020-02-07
61786SUPPL2020-02-06
57554SUPPL2019-02-13
57361SUPPL2019-01-28
55145SUPPL2018-08-09
55051SUPPL2018-07-30
47421SUPPL2017-03-02
47319SUPPL2017-02-24
34898SUPPL2016-03-03
25246SUPPL2016-03-03
2799SUPPL2014-05-09
12783SUPPL2014-04-29
41451SUPPL2013-06-03
41450SUPPL2013-06-03
34897SUPPL2012-08-03
2797SUPPL2012-08-03
25245SUPPL2012-03-13
23585ORIG2011-12-20
41452SUPPL2011-12-14
20742SUPPL2011-12-14
34894SUPPL2011-09-30
12782SUPPL2011-09-30
25241SUPPL2011-09-28
2798SUPPL2011-09-28
2795SUPPL2011-08-26
12779SUPPL2011-08-25
25244SUPPL2011-06-17
34896SUPPL2011-06-16
25243SUPPL2010-12-06
12781SUPPL2010-12-04
25242SUPPL2010-09-07
2796SUPPL2010-09-07
2794SUPPL2010-09-07
2792SUPPL2010-09-07
34895SUPPL2010-08-30
34893SUPPL2010-08-30
34892SUPPL2010-08-30
12780SUPPL2010-08-30
20741SUPPL2009-09-16
12778SUPPL2009-08-06
2793SUPPL2009-08-06
25240SUPPL2008-08-19
41449SUPPL2008-02-19
12777SUPPL2007-08-23
12776SUPPL2007-08-23
25239SUPPL2007-08-22
2791SUPPL2007-08-22
25237SUPPL2006-10-18
25236SUPPL2006-10-18
2790SUPPL2006-10-18
34890SUPPL2006-10-11
34889SUPPL2006-10-11
12775SUPPL2006-10-11
34891SUPPL2005-08-19
25238SUPPL2005-08-19
44451SUPPL2004-11-02
34888SUPPL2003-12-11
12774SUPPL2003-12-11
2788SUPPL2003-12-11
2787SUPPL2003-12-11
2786SUPPL2003-11-28
2789SUPPL2003-11-25
25235SUPPL2003-09-25
2785SUPPL2002-11-19
25234SUPPL2002-03-03
34887SUPPL1999-07-02
2784SUPPL1999-07-02
20740SUPPL1997-10-17