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)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 597620047 | NDA | Greenstone Llc | 2000-02-22 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | NDA021228 | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000932050 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals Usa Inc | 2014-01-02 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | NDA021228 | 2cad3579-d197-4019-ae94-460525b6a8d9 |
| 2 | 003783402 | ANDA | Mylan Pharmaceuticals Inc. | 2014-01-06 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | ANDA201486 | 7f3f6571-3234-42fd-ac5b-dba97714b399 |
| 3 | 136680189 | ANDA | Torrent Pharmaceuticals Limited | 2015-08-11 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | ANDA203016 | db6e0b6d-0ce5-41d7-881f-881c11f530a4 |
| 4 | 510790197 | ANDA | Mylan Institutional Inc. | 2014-01-28 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | ANDA201486 | 205b572b-dc91-48db-829e-179bade6b0ea |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685126 | Detrol | NDA | Physicians Total Care, Inc. | 2004-09-03 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | 000095190 | NDA021228 | 25994fad-388d-4f9c-950e-14b7f8073b8c |
| 2 | 551543935 | Detrol | NDA | Cardinal Health | 2000-12-22 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | 000095190 | NDA021228 | 5e29f133-270c-4e5a-8493-e038c163a891 |
24 hr tolterodine tartrate 4 mg extended release oral capsule
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 597620048 | NDA | Greenstone Llc | 2000-02-22 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | NDA021228 | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000932049 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals Usa Inc | 2014-01-02 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | NDA021228 | 2cad3579-d197-4019-ae94-460525b6a8d9 |
| 2 | 003783404 | ANDA | Mylan Pharmaceuticals Inc. | 2014-01-06 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | ANDA201486 | 7f3f6571-3234-42fd-ac5b-dba97714b399 |
| 3 | 510790198 | ANDA | Mylan Institutional Inc. | 2014-01-29 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | ANDA201486 | 205b572b-dc91-48db-829e-179bade6b0ea |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 353560417 | Detrol | NDA | Lake Erie Medical Dba Quality Care Products Llc | 2012-02-28 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | 000095191 | NDA021228 | ecb298ce-4817-4530-9aee-cf5f3041b836 |
| 2 | 548684514 | Detrol | NDA | Physicians Total Care, Inc. | 2004-09-03 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | 000095191 | NDA021228 | 25994fad-388d-4f9c-950e-14b7f8073b8c |
| 3 | 551543933 | Detrol | NDA | Cardinal Health | 2000-12-22 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | 000095191 | NDA021228 | 5e29f133-270c-4e5a-8493-e038c163a891 |
| 4 | 552890132 | Detrol | NDA | Pd-Rx Pharmaceuticals, Inc. | 2000-02-22 | TOLTERODINE TARTRATE | ORAL | CAPSULE, EXTENDED RELEASE | 000095191 | NDA021228 | 81df83d0-088c-4a13-9538-f362a0f35456 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA201486 | TOLTERODINE TARTRATE | MYLAN PHARMACEUTICALS INC | 2013-10-31 | ANDA201486_001, ANDA201486_002 | |
| 2 | ANDA203016 | TOLTERODINE TARTRATE | TORRENT PHARMACEUTICALS LTD | 2015-08-11 | ANDA203016_001, ANDA203016_002 | |
| 3 | NDA021228 | DETROL LA | PHARMACIA AND UPJOHN CO | 2000-12-22 | p6911217, 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)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA201486_001 | RX | TOLTERODINE TARTRATE (2MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | AB | 2013-10-31 | TOLTERODINE TARTRATE |
| 2 | ANDA201486_002 | RX | TOLTERODINE TARTRATE (4MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | AB | 2013-10-31 | TOLTERODINE TARTRATE |
| 3 | ANDA203016_001 | RX | TOLTERODINE TARTRATE (2MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | AB | 2015-08-11 | TOLTERODINE TARTRATE |
| 4 | ANDA203016_002 | RX | TOLTERODINE TARTRATE (4MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | AB | 2015-08-11 | TOLTERODINE TARTRATE |
| 5 | NDA021228_001 | RX | TOLTERODINE TARTRATE (2MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | AB | 2000-12-22 | DETROL LA |
| 6 | NDA021228_002 | RX | TOLTERODINE TARTRATE (4MG) | ORAL | CAPSULE, EXTENDED RELEASE | True | AB | 2000-12-22 | DETROL LA |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p6630162 (view patent) | 2019-11-11 | NDA021228 |
| 2 | p6770295 (view patent) | 2019-08-26 | NDA021228 |
| 3 | p6911217 (view patent) | 2019-11-11 | NDA021228 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0565f75a-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 2000 | prescription | Human Prescription | Greenstone Llc | 2014-05-30 | 1 | 597620047, 597620048 | |
| 2 | 205b572b-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 2000 | prescription | Human Prescription | Mylan Institutional Inc. | 2013-12-06 | 1 | 510790197, 510790198 | |
| 3 | 25994fad-388d-4f9c-950e-14b7f8073b8c (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-01-14 | 1 | 548684514, 548685126 | |
| 4 | 2cad3579-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 2000 | prescription | Human Prescription | Teva Pharmaceuticals Usa Inc | 2015-09-30 | 5 | 000932049, 000932050 | |
| 5 | 5e29f133-270c-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 2000 | prescription | Human Prescription | Cardinal Health | REPACK | 2014-08-06 | 5 | 551543933, 551543935 |
| 6 | 7f3f6571-3234-42fd-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 2000 | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2013-02-13 | 3 | 003783402, 003783404 | |
| 7 | 81df83d0-088c-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 2000 | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2011-09-28 | 6 | 552890132 |
| 8 | c98eb213-9c80-4698-9710-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 2000 | prescription | Human Prescription | Pharmacia And Upjohn Company | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK | 2013-09-20 | 12 | 000095190, 000095191 |
| 9 | db6e0b6d-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 2000 | prescription | Human Prescription | Torrent Pharmaceuticals Limited | 2015-08-12 | 1 | 136680189 | |
| 10 | ecb298ce-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 2000 | prescription | Human Prescription | Lake Erie Medical Dba Quality Care Products Llc | relabel, repack | 2012-02-28 | 3599 | 353560417 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII