Overview
A drug that has been used in various urinary syndromes and as an antispasmodic. Its therapeutic usefulness and its mechanism of action are not clear. It may have local anesthetic activity and direct relaxing effects on smooth muscle as well as some activity as a muscarinic antagonist. [PubChem]
Background
A drug that has been used in various urinary syndromes and as an antispasmodic. Its therapeutic usefulness and its mechanism of action are not clear. It may have local anesthetic activity and direct relaxing effects on smooth muscle as well as some activity as a muscarinic antagonist. [PubChem]
Indication
For symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis.
Associated Conditions
- Cystitis
- Dysuria
- Kidney Stones
- Menstrual Distress (Dysmenorrhea)
- Neurogenic Bladder
- Nocturia
- Pelvic Floor Dysfunctions
- Pelvic Pain
- Prostatitis
- Suprapubic pain
- Urethritis
- Urethrotrigonitis
- Urinary Incontinence (UI)
- Urinary Tract Infection
- Urinary Urgency
- Uterine dyskinesia
- Cystalgia
- Urethrocystitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2009/10/09 | Phase 1 | Completed | |||
2007/02/27 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-720 | ORAL | 100 mg in 1 1 | 12/21/2017 | |
| Carilion Materials Management | 68151-3826 | ORAL | 100 mg in 1 1 | 7/24/2014 | |
| Epic Pharma, LLC | 42806-058 | ORAL | 100 mg in 1 1 | 12/27/2023 | |
| Padagis US LLC | 0574-0115 | ORAL | 100 mg in 1 1 | 12/11/2021 | |
| Physicians Total Care, Inc. | 54868-6326 | ORAL | 100 mg in 1 1 | 1/25/2012 |
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 |
|---|---|---|---|---|---|
| CLEANXATE TAB 200 mg | SIN09677P | TABLET, SUGAR COATED | 200 mg | 3/19/1998 | |
| LAVOXEN TABLET 200 mg | SIN12299P | TABLET, FILM COATED | 200 mg | 5/22/2003 | |
| URIPAX FILM COATED TABLET 200MG | SIN16400P | TABLET, FILM COATED | 200mg | 12/14/2021 | |
| URISPAS 200 TABLET 200 mg | SIN12007P | TABLET, FILM COATED | 200 mg | 7/1/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Flavoxate Hydrochloride Capsules | 国药准字H19990014 | 化学药品 | 胶囊剂 | 2/25/2020 | |
| Flavoxate Hydrochloride Tablets | 国药准字H10940058 | 化学药品 | 片剂(糖衣) | 11/25/2020 | |
| Flavoxate Hydrochloride Tablets | 国药准字H10950321 | 化学药品 | 片剂 | 12/28/2020 | |
| Flavoxate Hydrochloride Tablets | 国药准字H10980306 | 化学药品 | 片剂 | 11/27/2020 | |
| Flavoxate Hydrochloride Tablets | 国药准字H10940009 | 化学药品 | 片剂 | 8/12/2020 | |
| Flavoxate Hydrochloride Tablets | 国药准字H20046439 | 化学药品 | 片剂 | 7/24/2020 | |
| Flavoxate Hydrochloride Tablets | 国药准字H44024055 | 化学药品 | 片剂(薄膜衣) | 12/18/2019 | |
| Flavoxate Hydrochloride Tablets | 国药准字H44024056 | 化学药品 | 片剂(薄膜衣,糖衣) | 12/25/2019 | |
| Flavoxate Hydrochloride Tablets | 国药准字H10940196 | 化学药品 | 片剂 | 7/24/2020 | |
| Flavoxate Hydrochloride Tablets | 国药准字H37020880 | 化学药品 | 片剂 | 1/15/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||