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Data updated: Mar 10, 2026

OXAZEPAM

OXAZEPAM
Neurology Approved 1987-01-16
8
Indications
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1987-01-16
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

OXAZEPAM Approval History

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What OXAZEPAM Treats

4 indications

OXAZEPAM is approved for 4 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anxiety Disorders
  • Anxiety
  • Depression
  • Alcohol Withdrawal
Source: FDA Label

OXAZEPAM Boxed Warning

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see WARNINGS a...

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OXAZEPAM FDA Label Details

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Indications & Usage

INDICATIONS Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Anxiety associated with depression is also responsive to oxazepam therapy. This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients. Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy. The e...

⚠️ BOXED WARNING

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in p...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.