Overview
Tolterodine is an antimuscarinic drug that is used to treat urinary incontinence. Tolterodine acts on M2 and M3 subtypes of muscarinic receptors.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/06/30 | Phase 3 | Completed | |||
2015/05/07 | Phase 4 | Completed | |||
2014/11/19 | Phase 4 | Completed | |||
2014/10/06 | Phase 4 | Completed | |||
2014/10/06 | Phase 4 | Completed | |||
2014/05/15 | Phase 4 | Completed | |||
2013/10/17 | Phase 4 | Completed | |||
2013/04/04 | Phase 4 | Completed | Buddhist Tzu Chi General Hospital | ||
2012/12/05 | Phase 4 | Completed | |||
2012/11/20 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Camber Pharmaceuticals, Inc. | 31722-806 | ORAL | 2 mg in 1 1 | 8/16/2021 | |
| Camber Pharmaceuticals, Inc. | 31722-607 | ORAL | 2 mg in 1 1 | 6/2/2017 | |
| Greenstone LLC | 59762-0047 | ORAL | 2 mg in 1 1 | 8/22/2018 | |
| Mylan Pharmaceuticals Inc. | 59762-0047 | ORAL | 2 mg in 1 1 | 8/22/2018 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7164 | ORAL | 4 mg in 1 1 | 1/20/2023 | |
| Ajanta Pharma USA Inc. | 27241-192 | ORAL | 4 mg in 1 1 | 11/24/2021 | |
| PHARMACIA & UPJOHN COMPANY LLC | 0009-4541 | ORAL | 1 mg in 1 1 | 9/29/2021 | |
| Drug Ocean LLC | 70985-023 | ORAL | 2 mg in 1 1 | 10/12/2023 | |
| Drug Ocean LLC | 70985-022 | ORAL | 1 mg in 1 1 | 10/12/2023 | |
| A-S Medication Solutions | 50090-3475 | ORAL | 4 mg in 1 1 | 1/20/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tolterodine L-Tartrate Sustained Release Capsules | 国药准字H20249375 | 化学药品 | 胶囊剂 | 11/15/2024 | |
| Tolterodine Fumarate Tablets | 国药准字H20052501 | 化学药品 | 片剂 | 11/10/2020 | |
| Tolterodine Fumarate Tablets | 国药准字H20052500 | 化学药品 | 片剂 | 11/10/2020 | |
| Tolterodine Tartrate Sustained Release Tablets | 国药准字H20070272 | 化学药品 | 片剂 | 5/6/2022 | |
| Tolterodine Tartrate Capsules | 国药准字H20000603 | 化学药品 | 胶囊剂 | 4/30/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||