Data updated: Mar 10, 2026
CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE
Approved 1975-03-07
16
Indications
--
Phase 3 Trials
51
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1975-03-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
IVAX SUB TEVA PHARMS USL PHARMA CHARTWELL RX Viatris PARKE DAVIS IMPAX LABS VANGARD ROXANE UPSHER SMITH LABS Hikma WATSON LABS ASCOT Teva SUPERPHARM HALSEY FERRANTE MAST MM LEDERLE PIONEER PHARMS PUREPAC PHARM
Active Ingredient: CHLORDIAZEPOXIDE HYDROCHLORIDE
Website: ↗
CHLORDIAZEPOXIDE HYDROCHLORIDE Approval History
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What CHLORDIAZEPOXIDE HYDROCHLORIDE Treats
16 FDA approvalsOriginally approved for its first indication in 1975 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Mar 1975)
- • Approved indication (Feb 1976)
- • Approved indication (Jun 1976)
- • Approved indication (Jun 1976)
- • Approved indication (Jul 1976)
- • Approved indication (Aug 1976)
- • Approved indication (Sep 1976)
- • Approved indication (Apr 1977)
- • Approved indication (Dec 1977)
- • Approved indication (Sep 1978)
- • Approved indication (Jul 1979)
- • Approved indication (Feb 1981)
- • Approved indication (Sep 1981)
- • Approved indication (Mar 1983)
- • Approved indication (Jan 1985)
- • Approved indication (Apr 1985)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
CHLORDIAZEPOXIDE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.