tolterodine Extended Release Oral Capsule

Brand(s)
Detrol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-09-30)
Oldest Current Product
2000-02-22
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\TOLTERODINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\TOLTERODINE TARTRATE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\TOLTERODINE TARTRATE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\TOLTERODINE

product(s) by strength(s)

24 hr tolterodine tartrate 2 mg extended release oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620047NDAGreenstone Llc2000-02-22TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASENDA0212280565f75a-3f4f-436e-930e-c31c6fa2b1e7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932050NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2014-01-02TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASENDA0212282cad3579-d197-4019-ae94-460525b6a8d9
2003783402ANDAMylan Pharmaceuticals Inc.2014-01-06TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASEANDA2014867f3f6571-3234-42fd-ac5b-dba97714b399
3136680189ANDATorrent Pharmaceuticals Limited2015-08-11TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASEANDA203016db6e0b6d-0ce5-41d7-881f-881c11f530a4
4510790197ANDAMylan Institutional Inc.2014-01-28TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASEANDA201486205b572b-dc91-48db-829e-179bade6b0ea

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685126DetrolNDAPhysicians Total Care, Inc.2004-09-03TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASE000095190NDA02122825994fad-388d-4f9c-950e-14b7f8073b8c
2551543935DetrolNDACardinal Health2000-12-22TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASE000095190NDA0212285e29f133-270c-4e5a-8493-e038c163a891

24 hr tolterodine tartrate 4 mg extended release oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620048NDAGreenstone Llc2000-02-22TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASENDA0212280565f75a-3f4f-436e-930e-c31c6fa2b1e7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932049NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2014-01-02TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASENDA0212282cad3579-d197-4019-ae94-460525b6a8d9
2003783404ANDAMylan Pharmaceuticals Inc.2014-01-06TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASEANDA2014867f3f6571-3234-42fd-ac5b-dba97714b399
3510790198ANDAMylan Institutional Inc.2014-01-29TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASEANDA201486205b572b-dc91-48db-829e-179bade6b0ea

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560417DetrolNDALake Erie Medical Dba Quality Care Products Llc2012-02-28TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASE000095191NDA021228ecb298ce-4817-4530-9aee-cf5f3041b836
2548684514DetrolNDAPhysicians Total Care, Inc.2004-09-03TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASE000095191NDA02122825994fad-388d-4f9c-950e-14b7f8073b8c
3551543933DetrolNDACardinal Health2000-12-22TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASE000095191NDA0212285e29f133-270c-4e5a-8493-e038c163a891
4552890132DetrolNDAPd-Rx Pharmaceuticals, Inc.2000-02-22TOLTERODINE TARTRATEORALCAPSULE, EXTENDED RELEASE000095191NDA02122881df83d0-088c-4a13-9538-f362a0f35456

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA201486TOLTERODINE TARTRATEMYLAN PHARMACEUTICALS INC2013-10-31ANDA201486_001, ANDA201486_002
2ANDA203016TOLTERODINE TARTRATETORRENT PHARMACEUTICALS LTD2015-08-11ANDA203016_001, ANDA203016_002
3NDA021228DETROL LAPHARMACIA AND UPJOHN CO2000-12-22p6911217, TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE., SUBSTANCE
p6630162, TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE., SUBSTANCE
p6770295, TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE., SUBSTANCE
NDA021228_001, NDA021228_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201486_001RXTOLTERODINE TARTRATE (2MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2013-10-31TOLTERODINE TARTRATE
2ANDA201486_002RXTOLTERODINE TARTRATE (4MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2013-10-31TOLTERODINE TARTRATE
3ANDA203016_001RXTOLTERODINE TARTRATE (2MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2015-08-11TOLTERODINE TARTRATE
4ANDA203016_002RXTOLTERODINE TARTRATE (4MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2015-08-11TOLTERODINE TARTRATE
5NDA021228_001RXTOLTERODINE TARTRATE (2MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2000-12-22DETROL LA
6NDA021228_002RXTOLTERODINE TARTRATE (4MG)ORALCAPSULE, EXTENDED RELEASETrueAB2000-12-22DETROL LA

patent(s)

#idexpiration dateapplication(s)
1p6630162 (view patent)2019-11-11NDA021228
2p6770295 (view patent)2019-08-26NDA021228
3p6911217 (view patent)2019-11-11NDA021228

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10565f75a-3f4f-436e-930e-c31c6fa2b1e7 (view SPL)These highlights do not include all the information needed to use tolterodine tartrate extended-release capsules safely and effectively. See full prescribing information for tolterodine tartrate extended-release capsules. Tolterodine tartrate extended-release capsulesFor oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionGreenstone Llc2014-05-301597620047, 597620048
2205b572b-dc91-48db-829e-179bade6b0ea (view SPL)These highlights do not include all the information needed to use tolterodine tartrate extended-release capsules safely and effectively. See full prescribing information for tolterodine tartrate extended-release capsules.TOLTERODINE tartrate extended-release capsulesFor oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionMylan Institutional Inc.2013-12-061510790197, 510790198
325994fad-388d-4f9c-950e-14b7f8073b8c (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-141548684514, 548685126
42cad3579-d197-4019-ae94-460525b6a8d9 (view SPL)These highlights do not include all the information needed to use tolterodine tartrate extended-release capsules safely and effectively. See full prescribing information for tolterodine tartrate extended-release capsules. Tolterodine tartrate extended-release capsulesFor oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-305000932049, 000932050
55e29f133-270c-4e5a-8493-e038c163a891 (view SPL)These highlights do not include all the information needed to use Detrol LA safely and effectively. See full prescribing information for Detrol LA. Detrol LA (tolterodine tartrate extended release capsules)For oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionCardinal HealthREPACK2014-08-065551543933, 551543935
67f3f6571-3234-42fd-ac5b-dba97714b399 (view SPL)These highlights do not include all the information needed to use tolterodine tartrate extended-release capsules safely and effectively. See full prescribing information for tolterodine tartrate extended-release capsules.TOLTERODINE tartrate extended-release capsulesFor oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-02-133003783402, 003783404
781df83d0-088c-4a13-9538-f362a0f35456 (view SPL)These highlights do not include all the information needed to use Detrol LA safely and effectively. See full prescribing information for Detrol LA. Detrol LA (tolterodine tartrate extended release capsules)For oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-286552890132
8c98eb213-9c80-4698-9710-a9855059b8bb (view SPL)These highlights do not include all the information needed to use Detrol LA safely and effectively. See full prescribing information for Detrol LA. Detrol LA (tolterodine tartrate extended release capsules)For oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-09-2012000095190, 000095191
9db6e0b6d-0ce5-41d7-881f-881c11f530a4 (view SPL)These highlights do not include all the information needed to use tolterodine tartrate extended-release capsules safely and effectively. See full prescribing information for tolterodine tartrate extended-release capsules.TOLTERODINE tartrate extended-release capsules, for oral administration Initial U.S. Approval: December 2000prescriptionHuman PrescriptionTorrent Pharmaceuticals Limited2015-08-121136680189
10ecb298ce-4817-4530-9aee-cf5f3041b836 (view SPL)These highlights do not include all the information needed to use Detrol LA safely and effectively. See full prescribing information for Detrol LA. Detrol LA (tolterodine tartrate extended release capsules)For oral administrationInitial U.S. Approval: December 2000prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-02-283599353560417

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