MedPath

Oxazepam

Generic Name
Oxazepam
Brand Names
Oxpam
Drug Type
Small Molecule
Chemical Formula
C15H11ClN2O2
CAS Number
604-75-1
Unique Ingredient Identifier
6GOW6DWN2A

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

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.
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