Overview
Oxazepam is an intermediate-acting, 3-hydroxybenzodiazepine used in the treatment of alcohol withdrawal and anxiety disorders. Oxazepam, like related 3-hydroxybenzodiazepine lorazepam, is considered less susceptible to pharmacokinetic variability based on patient-specific factors (e.g. age, liver disease) - this feature is advantageous as compared to other benzodiazepines, and is likely owing in part to oxazepam's relatively simple metabolism. It is an active metabolite of both diazepam and temazepam and undergoes very little biotransformation following absorption, making it unlikely to participate in pharmacokinetic interactions.
Background
Oxazepam is an intermediate-acting, 3-hydroxybenzodiazepine used in the treatment of alcohol withdrawal and anxiety disorders. Oxazepam, like related 3-hydroxybenzodiazepine lorazepam, is considered less susceptible to pharmacokinetic variability based on patient-specific factors (e.g. age, liver disease) - this feature is advantageous as compared to other benzodiazepines, and is likely owing in part to oxazepam's relatively simple metabolism. It is an active metabolite of both diazepam and temazepam and undergoes very little biotransformation following absorption, making it unlikely to participate in pharmacokinetic interactions.
Indication
Oxazepam is indicated for the management of anxiety disorders and for the short-term relief of symptoms of anxiety. It may also be used in the management of alcohol withdrawal symptoms.
Associated Conditions
- Alcohol Withdrawal Syndrome
- Anxiety
- Anxiety Disorders
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/03/02 | Phase 3 | Terminated | |||
2014/10/24 | Phase 1 | Completed | |||
2014/03/18 | Phase 4 | Completed | |||
2007/12/05 | Not Applicable | Completed | |||
2001/08/31 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actavis Pharma, Inc. | 0228-2067 | ORAL | 10 mg in 1 1 | 1/12/2024 | |
| American Health Packaging | 62584-812 | ORAL | 10 mg in 1 1 | 12/2/2023 | |
| Aphena Pharma Solutions - Tennessee, Inc. | 43353-074 | ORAL | 30 mg in 1 1 | 4/6/2012 | |
| Aphena Pharma Solutions - Tennessee, LLC | 67544-117 | ORAL | 10 mg in 1 1 | 3/31/2014 | |
| STAT RX USA LLC | 16590-304 | ORAL | 15 mg in 1 1 | 12/15/2009 | |
| Actavis Pharma, Inc. | 0228-2069 | ORAL | 15 mg in 1 1 | 1/12/2024 | |
| TruPharma, LLC | 52817-290 | ORAL | 10 mg in 1 1 | 3/3/2021 | |
| American Health Packaging | 62584-813 | ORAL | 15 mg in 1 1 | 12/2/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-965 | ORAL | 10 mg in 1 1 | 12/16/2014 | |
| TruPharma, LLC | 52817-292 | ORAL | 30 mg in 1 1 | 3/3/2021 |
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 |
|---|---|---|---|---|---|
| Oxazepam Tablets | 国药准字H20253141 | 化学药品 | 片剂 | 1/14/2025 | |
| Oxazepam Tablets | 国药准字H11020894 | 化学药品 | 片剂 | 6/1/2020 |
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 |
|---|---|---|---|---|---|
| MURELAX Oxazepam 15mg tablet | 75122 | Medicine | A | 7/20/2000 | |
| ALEPAM 30 oxazepam 30mg tablet blister pack | 385082 | Medicine | A | 7/12/2022 | |
| MURELAX Oxazepam 30mg tablet | 12952 | Medicine | A | 8/19/1991 | |
| ALEPAM 15 oxazepam 15mg tablet lister pack | 385081 | Medicine | A | 7/12/2022 | |
| SEREPAX oxazepam 30 mg tablet blister pack | 10417 | Medicine | A | 7/4/1991 | |
| SEREPAX oxazepam 15 mg tablet blister pack | 174675 | Medicine | A | 11/23/2010 | |
| APO-OXAZEPAM oxazepam 30mg tablet | 163213 | Medicine | A | 5/12/2010 | |
| OXAZEPAM-WGR Oxazepam 30 mg tablet blister pack | 423290 | Medicine | A | 1/3/2024 | |
| OXAZEPAM MYLAN oxazepam 30mg tablet bottle | 369611 | Medicine | A | 10/11/2021 | |
| OXAZEPAM MYLAN oxazepam 15mg tablet bottle | 369610 | Medicine | A | 10/11/2021 |