Overview
An anxiolytic benzodiazepine derivative with anticonvulsant, sedative, and amnesic properties. It has also been used in the symptomatic treatment of alcohol withdrawal.
Indication
Chlordiazepoxide is indicated for the management of anxiety disorders or for the short-term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. In combination with amitriptyline, chlordiazepoxide is indicated for the treatment of moderate to severe depression. In combination with clidinium, chlordiazepoxide is indicated to control emotional and somatic factors in gastrointestinal disorders, and is used as adjunctive therapy in the treatment of peptic ulcer, irritable bowel syndrome and acute enterocolitis.
Associated Conditions
- Alcohol Withdrawal Syndrome
- Anxiety Disorders
- Depression
- Irritable Bowel Syndrome (IBS)
- Peptic Ulcer Disease
- Preoperative Anxiety
- Acute Enterocolitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/03 | Phase 2 | Recruiting | |||
2025/04/10 | Not Applicable | Recruiting | General Hospital of Shenyang Military Region | ||
2024/05/22 | Phase 2 | Completed | |||
2024/02/26 | Not Applicable | Recruiting | Phramongkutklao College of Medicine and Hospital | ||
2023/11/02 | Phase 3 | Completed | |||
2022/11/30 | Phase 3 | Recruiting | |||
2022/10/26 | Phase 2 | ENROLLING_BY_INVITATION | |||
2021/03/25 | Phase 4 | Completed | F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica | ||
2020/05/19 | Phase 3 | UNKNOWN | |||
2018/09/06 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sunrise Pharmaceutical, Inc. | 11534-197 | ORAL | 5 mg in 1 1 | 8/8/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-969 | ORAL | 10 mg in 1 1 | 11/22/2017 | |
| Contract Pharmacy Services-PA | 67046-909 | ORAL | 10 mg in 1 1 | 10/3/2017 | |
| Marlex Pharmaceuticals Inc | 10135-622 | ORAL | 5 mg in 1 1 | 6/28/2016 | |
| Alembic Pharmaceuticals Inc. | 62332-744 | ORAL | 5 mg in 1 1 | 10/5/2023 | |
| Chartwell RX, LLC | 62135-696 | ORAL | 5 mg in 1 1 | 10/5/2023 | |
| Physicians Total Care, Inc. | 54868-0070 | ORAL | 10 mg in 1 1 | 12/28/2011 | |
| Contract Pharmacy Services-PA | 67046-912 | ORAL | 10 mg in 1 1 | 8/31/2017 | |
| Aidarex Pharmaceuticals LLC | 53217-183 | ORAL | 25 mg in 1 1 | 3/1/2017 | |
| Epic Pharma, LLC | 42806-565 | ORAL | 10 mg in 1 1 | 2/7/2023 |
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 |
|---|---|---|---|---|---|
| CHLOBAX TABLET | SIN08651P | TABLET, SUGAR COATED | 5 mg | 4/19/1996 | |
| AA PHARMA CHLORAX CAPSULE | SIN03049P | CAPSULE | 5 mg | 6/7/1989 | |
| BENPINE TABLET 5 mg | ATLANTIC LABORATORIES CORPN LTD | SIN01907P | TABLET, SUGAR COATED | 5 mg | 6/20/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE CAP 2.5MG | N/A | N/A | N/A | 9/16/1986 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Chlordiazepoxide & Amitriptyline 10/25 mg Tablets Bottle | 368272 | Medicine | A | 6/4/2021 | |
| Chlordiazepoxide & Amitriptyline 5/12.5 mg Tablets Bottle | 368273 | Medicine | A | 6/4/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CHLORAX | aa pharma inc | 00618454 | Capsule - Oral | 5 MG | 12/31/1984 |
| NOVO-POXIDE 5MG | novopharm limited | 00020915 | Capsule - Oral | 5 MG / CAP | 12/31/1970 |
| NOVO-POXIDE 25MG | novopharm limited | 00020931 | Capsule - Oral | 25 MG / CAP | 12/31/1970 |
| MEDILIUM CAP 5MG | medic laboratory ltée | 00134325 | Capsule - Oral | 5 MG / CAP | 12/31/1971 |
| CHLORDIAZEPOXYDE 25 CAP | 00448737 | Capsule - Oral | 25 MG / CAP | 12/31/1981 | |
| CORAX CAP 10MG | icn canada ltd. | 00235873 | Capsule - Oral | 10 MG / CAP | 12/31/1968 |
| CHLORDIAZEPOXIDE | aa pharma inc | 00522996 | Capsule - Oral | 25 MG | 12/31/1981 |
| CHLORDIAZEPOXIDE CAP 5MG | PRO DOC LIMITEE | 00363596 | Capsule - Oral | 5 MG / CAP | 12/31/1976 |
| CORAX CAP 25MG | icn canada ltd. | 00267090 | Capsule - Oral | 25 MG / CAP | 12/31/1973 |
| PRO CHLORAX | PRO DOC LIMITEE | 00636223 | Capsule - Oral | 5 MG | 12/31/1984 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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