Overview
Tolterodine is an antimuscarinic drug that is used to treat urinary incontinence. Tolterodine acts on M2 and M3 subtypes of muscarinic receptors.
Indication
For the treatment of overactive bladder (with symptoms of urinary frequency, urgency, or urge incontinence).
Associated Conditions
- Urinary Urge Incontinence
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/01 | N/A | Active, not recruiting | Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital | ||
2023/07/14 | Phase 4 | Recruiting | |||
2022/05/05 | Phase 4 | Recruiting | |||
2022/02/22 | Phase 4 | Completed | Yuzuncu Yıl University | ||
2020/08/05 | Phase 1 | Completed | Kasr El Aini Hospital | ||
2018/07/27 | N/A | Completed | |||
2018/07/11 | Phase 3 | Completed | |||
2018/06/28 | N/A | Completed | |||
2018/04/10 | Phase 3 | Completed | |||
2015/11/06 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-6592 | ORAL | 2 mg in 1 1 | 11/13/2019 | |
| Slate Run Pharmaceuticals, LLC | 70436-161 | ORAL | 4 mg in 1 1 | 12/13/2023 | |
| Greenstone LLC | 59762-0170 | ORAL | 1 mg in 1 1 | 9/11/2017 | |
| Mylan Pharmaceuticals Inc. | 59762-0170 | ORAL | 1 mg in 1 1 | 9/11/2017 | |
| Viatris Specialty LLC | 58151-103 | ORAL | 2 mg in 1 1 | 3/15/2023 | |
| Avera McKennan Hospital | 69189-5190 | ORAL | 2 mg in 1 1 | 3/23/2017 | |
| Golden State Medical Supply, Inc. | 51407-739 | ORAL | 2 mg in 1 1 | 12/28/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7163 | ORAL | 2 mg in 1 1 | 1/20/2023 | |
| Torrent Pharmaceuticals Limited | 13668-189 | ORAL | 2 mg in 1 1 | 10/27/2022 | |
| ANI Pharmaceuticals, Inc. | 43975-322 | ORAL | 2 mg in 1 1 | 2/1/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TOLTERODINE MEVON SR CAPSULE 2 MG | SIN16433P | CAPSULE, EXTENDED RELEASE | 2 mg | 2/28/2022 | |
| TOLTERODINE MEVON SR CAPSULE 4 MG | SIN16432P | CAPSULE, EXTENDED RELEASE | 4 mg | 2/28/2022 | |
| TOLCORD 2 FILM COATED TABLET 2 MG | SIN16597P | TABLET, FILM COATED | 2.0 MG | 9/7/2022 | |
| DETRUSITOL TABLET 1 mg | SIN09911P | TABLET, FILM COATED | 1 mg | 7/28/1998 | |
| TOLTERODINE MEVON IR FILM-COATED TABLET 2 MG | SIN16313P | TABLET, FILM COATED | 2.00 mg | 8/31/2021 | |
| TOLCORD 1 FILM COATED TABLET 1 MG | SIN16598P | TABLET, FILM COATED | 1.0 MG | 9/7/2022 | |
| DETRUSITOL SR CAPSULE 4 mg | SIN11857P | CAPSULE, EXTENDED RELEASE | 4 mg | 4/1/2002 | |
| DETRUSITOL TABLET 2 mg | SIN09912P | TABLET, FILM COATED | 2 mg | 7/28/1998 | |
| DETRUSITOL SR CAPSULE 2 mg | SIN11859P | CAPSULE, EXTENDED RELEASE | 2 mg | 4/1/2002 | |
| TOLTERODINE MEVON IR FILM-COATED TABLET 1 MG | SIN16314P | TABLET, FILM COATED | 1.00 mg | 8/31/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tolterodine Tartrate Tablets | 国药准字H20000611 | 化学药品 | 片剂 | 8/3/2020 | |
| Tolterodine Tartrate Tablets | 国药准字H20000614 | 化学药品 | 片剂 | 5/20/2020 | |
| Tolterodine Tartrate Tablets | 国药准字H20000607 | 化学药品 | 片剂 | 5/22/2020 | |
| Tolterodine Tartrate Tablets | 国药准字H20000612 | 化学药品 | 片剂 | 8/3/2020 | |
| Tolterodine Tartrate Tablets | 国药准字H20000609 | 化学药品 | 片剂 | 2/26/2020 | |
| Tolterodine Tartrate Tablets | 国药准字H20000602 | 化学药品 | 片剂 | 7/24/2020 | |
| Tolterodine Tartrate Tablets | 国药准字H20050779 | 化学药品 | 片剂 | 5/22/2020 | |
| Tolterodine Tartrate Dispersible Tablets | 国药准字H20060962 | 化学药品 | 片剂(分散) | 5/20/2020 | |
| Tolterodine L-Tartrate Sustained Release Capsules | 国药准字H20249395 | 化学药品 | 胶囊剂 | 11/15/2024 | |
| Tolterodine L-Tartrate Sustained Release Capsules | 国药准字H20249396 | 化学药品 | 胶囊剂 | 11/15/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DETRUSITOL tolterodine tartrate 1mg tablet blister pack | 99393 | Medicine | A | 12/15/2004 | |
| DETRUSITOL tolterodine tartrate 2mg tablet blister pack | 99394 | Medicine | A | 12/15/2004 |
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