TheraRadar
Data updated: Jul 17, 2026

SERAX (oxazepam) · ALPHARMA US PHARMS

CNS Approved 1965-06-04

SERAX is FDA-approved to treat 4 conditions (same as OXAZEPAM).

1
Indication
--
Phase 3 Trials
61
Years on Market

Details

Status
Discontinued
First Approved
1965-06-04
Routes
ORAL
Dosage Forms
TABLET, CAPSULE

Companies

Active Ingredient: OXAZEPAM

SERAX Approval History

1966
1967
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Original
New Indication
New Form
Label Update
88 FDA actions from 1965 to 2001
Nov 2001 SUPPL
Mfg · Manufacturing (CMC)
Aug 2001 SUPPL
Label · Labeling
Apr 2000 SUPPL
Label · Labeling

What SERAX Treats

4 indications

SERAX is approved for 4 conditions since its original approval in 1965. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anxiety Disorders
  • Anxiety
  • Depression
  • Alcohol Withdrawal

Same approved indications as OXAZEPAM (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02374567 GAP GAP-2014 Ph 3 terminated Pharmacovigilance in Gerontopsychiatric Patients
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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.

SERAX FDA Label Details

Indications & Usage

FDA Label (PDF)

SERAX is FDA-approved to treat 4 conditions — same approved indications as OXAZEPAM.

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Data Sources

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