FDA.reportPublic FDA data

Application 020897

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DITROPAN XLOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGYesNo
002DITROPAN XLOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGYesNo
003DITROPAN XLOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7521oxybutynin chlorideoxybutynin chlorideNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
10147-0761Oxybutynin Chlorideoxybutynin chloridePatriot Pharmaceuticals, LLCNDACurrent
10147-0761Oxybutynin Chlorideoxybutynin chloridePatriot Pharmaceuticals, NDACurrent
10147-0761Oxybutynin Chlorideoxybutynin chloridePatriot Pharmaceuticals, LLCNDACurrent
10147-0771Oxybutynin Chlorideoxybutynin chloridePatriot Pharmaceuticals, LLCNDACurrent
10147-0771Oxybutynin Chlorideoxybutynin chloridePatriot Pharmaceuticals, NDACurrent
10147-0771Oxybutynin Chlorideoxybutynin chloridePatriot Pharmaceuticals, LLCNDACurrent
50458-805Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-805Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-805Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-805Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-805Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-805Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-805Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-810Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-810Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-810Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-810Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-810Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-810Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-810Ditropanoxybutynin chlorideJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66923SUPPL2021-03-30
66920SUPPL2021-03-30
59998SUPPL2019-09-13
59997SUPPL2019-09-13
56191SUPPL2018-11-06
56138SUPPL2018-10-29
45407SUPPL2016-09-28
45294SUPPL2016-09-15
35595SUPPL2015-03-04
3684SUPPL2015-03-02
35594SUPPL2013-08-09
26140SUPPL2013-08-05
13693SUPPL2012-11-15
26139SUPPL2012-11-14
35593SUPPL2012-03-27
3683SUPPL2012-03-27
35592SUPPL2011-12-20
26138SUPPL2011-12-20
3682SUPPL2011-07-05
13692SUPPL2011-06-30
13691SUPPL2009-07-23
26137SUPPL2009-07-17
3681SUPPL2008-03-17
13690SUPPL2008-02-14
41790SUPPL2007-04-11
35591SUPPL2004-07-01
26136SUPPL2004-06-30
3680SUPPL2003-05-29
35590SUPPL2003-04-16
13689SUPPL2003-04-16
35589ORIG1998-12-16
26135ORIG1998-12-16
21049ORIG1998-12-16
53120ORIG1900-01-01
53119ORIG1900-01-01
53118ORIG1900-01-01