FDA.reportPublic FDA data

Application 021228

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DETROL LATOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL2MGYesNo
002DETROL LATOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL4MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5190Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5190Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5190Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5191Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5191Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5191Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0093-2049Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-2050Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
55154-3933Detrol LAtolterodine tartrateCardinal HealthNDACurrent
55154-3935Detrol LAtolterodine tartrateCardinal HealthNDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
59762-0047Tolterodine Tartrate Extended Releasetolterodine tartrateGreenstone LLCNDACurrent
59762-0048Tolterodine Tartrate Extended Releasetolterodine tartrateGreenstone LLCNDACurrent
68151-4247Tolterodine TartrateTolterodine TartrateCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-4281Tolterodine TartrateTolterodine TartrateCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
69189-5190Detrol LAtolterodine tartrateAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54929SUPPL2018-07-20
54920SUPPL2018-07-19
47866SUPPL2017-04-05
4707SUPPL2012-08-03
14682SUPPL2012-08-02
36419SUPPL2011-09-23
4706SUPPL2011-09-23
36418SUPPL2010-01-08
27140SUPPL2010-01-06
4705SUPPL2008-09-15
42042SUPPL2007-06-11
42041SUPPL2007-06-11
42040SUPPL2007-06-11
21527SUPPL2007-06-11
4704SUPPL2007-03-23
14681SUPPL2005-10-25
4703SUPPL2005-10-25
36417SUPPL2005-07-21
27139SUPPL2005-07-21
36416SUPPL2004-05-03
27138SUPPL2004-04-20
21526ORIG2004-02-11
4702SUPPL2004-01-22
27137SUPPL2003-07-28
14680SUPPL2003-05-01
36415ORIG2000-12-22
4701ORIG2000-12-22
53140ORIG1900-01-01
53139ORIG1900-01-01
53138ORIG1900-01-01
53137ORIG1900-01-01
53136ORIG1900-01-01
53135ORIG1900-01-01
53134ORIG1900-01-01
53133ORIG1900-01-01