Overview
A centrally acting central muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain. (From Martindale, The Extra Pharmacopoea, 30th ed, p1202)
Background
A centrally acting central muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain. (From Martindale, The Extra Pharmacopoea, 30th ed, p1202)
Indication
For the relief of discomfort associated with acute painful musculoskeletal conditions.
Associated Conditions
- Acute painful musculoskeletal conditions
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/02/25 | Phase 1 | Completed | |||
2017/04/06 | Phase 1 | Completed | |||
2015/04/01 | Phase 4 | Completed | Northern Orthopaedic Division, Denmark | ||
2013/09/02 | Phase 4 | Completed | |||
2011/04/27 | Phase 4 | Completed | |||
2010/08/24 | Phase 1 | Completed | University Hospital, Basel, Switzerland |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-9158 | ORAL | 500 mg in 1 1 | 3/26/2020 | |
| A-S Medication Solutions | 50090-0315 | ORAL | 500 mg in 1 1 | 8/27/2019 | |
| Bryant Ranch Prepack | 71335-2009 | ORAL | 500 mg in 1 1 | 5/25/2023 | |
| Dispensing Solutions, Inc. | 55045-1594 | ORAL | 500 mg in 1 1 | 9/7/2011 | |
| Aurobindo Pharma Limited | 59651-306 | ORAL | 500 mg in 1 1 | 9/5/2023 | |
| Actavis Pharma, Inc. | 0591-2520 | ORAL | 500 mg in 1 1 | 7/31/2019 | |
| Aurobindo Pharma Limited | 59651-305 | ORAL | 375 mg in 1 1 | 9/5/2023 | |
| Lake Erie Medical DBA Quality Care Products LLC | 55700-517 | ORAL | 375 mg in 1 1 | 4/17/2017 | |
| Rebel Distributors Corp | 21695-569 | ORAL | 500 mg in 1 1 | 11/3/2006 | |
| Rising Pharma Holdings, Inc. | 16571-725 | ORAL | 375 mg in 1 1 | 6/9/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Chlorzoxazoni Capsules | 国药准字H10940024 | 化学药品 | 胶囊剂 | 9/11/2020 | |
| Chlorzoxazone Tablets | 国药准字H14023762 | 化学药品 | 片剂 | 5/26/2022 | |
| Chlorzoxazone Tablets | 国药准字H20063434 | 化学药品 | 片剂 | 5/14/2020 | |
| Chlorzoxazone Tablets | 国药准字H42022720 | 化学药品 | 片剂 | 7/8/2020 | |
| Chlorzoxazone Tablets | 国药准字H32023070 | 化学药品 | 片剂 | 7/28/2020 | |
| Chlorzoxazone Tablets | 国药准字H35020642 | 化学药品 | 片剂 | 8/4/2021 | |
| Chlorzoxazone Tablets | 国药准字H37023819 | 化学药品 | 片剂 | 12/10/2019 | |
| Chlorzoxazone Tablets | 国药准字H42022894 | 化学药品 | 片剂 | 8/19/2020 | |
| Chlorzoxazone Tablets | 国药准字H13022408 | 化学药品 | 片剂 | 7/31/2020 | |
| Chlorzoxazone Tablets | 国药准字H51024030 | 化学药品 | 片剂 | 11/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SOLAXIN TAB 200MG | N/A | N/A | N/A | 12/20/1988 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||