tolterodine Oral Tablet

Brand(s)
Detrol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-10-06)
Oldest Current Product
1998-03-25
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\TOLTERODINE
FDAOB
ORAL\TABLET\TOLTERODINE TARTRATE
SPL Active
ORAL\TABLET, FILM COATED\TOLTERODINE TARTRATE
SPL Moiety
ORAL\TABLET, FILM COATED\TOLTERODINE

product(s) by strength(s)

tolterodine tartrate 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000094541DetrolNDAPharmacia And Upjohn Company1998-03-25TOLTERODINE TARTRATEORALTABLET, FILM COATEDNDA02077142f819c9-4108-4ca7-92c5-a213037dd4db

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930010ANDATeva Pharmaceuticals Usa Inc2015-11-01TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA077006d27e25b5-5d02-419f-b098-41fb162c5872
2000932056NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2012-05-11TOLTERODINE TARTRATEORALTABLET, FILM COATEDNDA02077155a35eb9-44ff-4762-8779-1a6ed5c90423
3003785445ANDAMylan Pharmaceuticals Inc.2012-11-28TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA202641304023e8-57ad-4dd7-9cf0-a4524623aa6c
4333420097ANDAMacleods Pharmaceuticals Limited2015-10-08TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA2034093f2291c3-7e3c-41be-afa6-ef73ce896e30
5597620170NDA AUTHORIZED GENERICGreenstone Llc2014-01-21TOLTERODINE TARTRATEORALTABLET, FILM COATEDNDA0207719e432622-2e6f-4cf8-892f-510288dd50f2
6605053527ANDAApotex Corp2012-09-25TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA20016487f9227b-eb78-951c-ac0e-df23d2e43053

tolterodine tartrate 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000094544DetrolNDAPharmacia And Upjohn Company1998-03-25TOLTERODINE TARTRATEORALTABLET, FILM COATEDNDA02077142f819c9-4108-4ca7-92c5-a213037dd4db

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930018ANDATeva Pharmaceuticals Usa Inc2015-11-01TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA077006d27e25b5-5d02-419f-b098-41fb162c5872
2000932055NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2012-05-11TOLTERODINE TARTRATEORALTABLET, FILM COATEDNDA02077155a35eb9-44ff-4762-8779-1a6ed5c90423
3003785446ANDAMylan Pharmaceuticals Inc.2012-11-28TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA202641304023e8-57ad-4dd7-9cf0-a4524623aa6c
4333420098ANDAMacleods Pharmaceuticals Limited2015-10-08TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA2034093f2291c3-7e3c-41be-afa6-ef73ce896e30
5597620800NDA AUTHORIZED GENERICGreenstone Llc2014-01-21TOLTERODINE TARTRATEORALTABLET, FILM COATEDNDA0207719e432622-2e6f-4cf8-892f-510288dd50f2
6605053528ANDAApotex Corp2012-09-25TOLTERODINE TARTRATEORALTABLET, FILM COATEDANDA20016487f9227b-eb78-951c-ac0e-df23d2e43053

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900959DetrolNDAStat Rx Usa Llc1998-03-25TOLTERODINE TARTRATEORALTABLET, FILM COATED000094544NDA020771fa938543-29b3-46ce-a176-5563bc8f2f80
2510790235ANDAMylan Institutional Inc.2013-03-26TOLTERODINE TARTRATEORALTABLET, FILM COATED003785446ANDA20264124dce9a2-f25e-4f8c-aaf5-caf461fbee96

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077006TOLTERODINE TARTRATEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2015-02-23ANDA077006_001, ANDA077006_002
2ANDA200164TOLTERODINE TARTRATEAPOTEX CORP2012-09-25ANDA200164_001, ANDA200164_002
3ANDA202641TOLTERODINE TARTRATEMYLAN PHARMACEUTICALS INC2012-11-27ANDA202641_001, ANDA202641_002
4ANDA203409TOLTERODINE TARTRATEMACLEODS PHARMACEUTICALS LTD2015-08-31ANDA203409_001, ANDA203409_002
5NDA020771DETROLPHARMACIA AND UPJOHN CO1998-03-25NDA020771_001, NDA020771_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077006_001RXTOLTERODINE TARTRATE (1MG)ORALTABLETFalseAB2015-02-23TOLTERODINE TARTRATE
2ANDA077006_002RXTOLTERODINE TARTRATE (2MG)ORALTABLETFalseAB2015-02-23TOLTERODINE TARTRATE
3ANDA200164_001RXTOLTERODINE TARTRATE (1MG)ORALTABLETFalseAB2012-09-25TOLTERODINE TARTRATE
4ANDA200164_002RXTOLTERODINE TARTRATE (2MG)ORALTABLETFalseAB2012-09-25TOLTERODINE TARTRATE
5ANDA202641_001RXTOLTERODINE TARTRATE (1MG)ORALTABLETFalseAB2012-11-27TOLTERODINE TARTRATE
6ANDA202641_002RXTOLTERODINE TARTRATE (2MG)ORALTABLETFalseAB2012-11-27TOLTERODINE TARTRATE
7ANDA203409_001RXTOLTERODINE TARTRATE (1MG)ORALTABLETFalseAB2015-08-31TOLTERODINE TARTRATE
8ANDA203409_002RXTOLTERODINE TARTRATE (2MG)ORALTABLETFalseAB2015-08-31TOLTERODINE TARTRATE
9NDA020771_001RXTOLTERODINE TARTRATE (1MG)ORALTABLETFalseAB1998-03-25DETROL
10NDA020771_002RXTOLTERODINE TARTRATE (2MG)ORALTABLETTrueAB1998-03-25DETROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
124dce9a2-f25e-4f8c-aaf5-caf461fbee96 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2012-09-072510790235
2304023e8-57ad-4dd7-9cf0-a4524623aa6c (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-07-232003785445, 003785446
33f2291c3-7e3c-41be-afa6-ef73ce896e30 (view SPL)Tolterodine Tartrate TabletsprescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-10-081333420097, 333420098
442f819c9-4108-4ca7-92c5-a213037dd4db (view SPL)Detrol tolterodine tartrate tabletsprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-10-0611000094541, 000094544
555a35eb9-44ff-4762-8779-1a6ed5c90423 (view SPL)Tolterodine Tartrate TabletsprescriptionHuman PrescriptionTeva Pharmaceuticals Usa IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-08-318000932055, 000932056
687f9227b-eb78-951c-ac0e-df23d2e43053 (view SPL)Tolterodine Tartrate Tablets 1 mg and 2 mgprescriptionHuman PrescriptionApotex Corp2011-02-151605053527, 605053528
79e432622-2e6f-4cf8-892f-510288dd50f2 (view SPL)Tolterodine Tartrate TabletsprescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE2014-07-014597620170, 597620800
8d27e25b5-5d02-419f-b098-41fb162c5872 (view SPL)TOLTERODINE TARTRATE TABLETSprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-051000930010, 000930018
9fa938543-29b3-46ce-a176-5563bc8f2f80 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-011165900959

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII