Data updated: Mar 10, 2026
DIAZEPAM
DIAZEPAM
Approved 1985-09-04
36
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 1985-09-04
- Routes
- ORAL, INJECTION, RECTAL
- Dosage Forms
- Spray, TABLET, INJECTABLE, GEL, SOLUTION, CONCENTRATE
Companies
PADAGIS ISRAEL PHARMA LTD WARNER CHILCOTT CHARTWELL RX Hikma IVAX SUB TEVA PHARMS DURAMED PHARMS BARR WATSON LABS INC NAVINTA LLC Dr. Reddy's PH HEALTH Viatris ROXANE VIRTUS Teva WATSON LABS FERNDALE LABS HALSEY GALENICUM HLTH PIONEER PHARMS Pfizer CHARTWELL MOLECULAR ABRAXIS PHARM STRIDES PHARMA INTL LONG GROVE PHARMS DAVA PHARMS INC US ARMY ALEMBIC NUVO PHARM NOVEL LABS INC REGCON HOLDINGS PARENTA PHARMS Aurobindo Pharma MARSAM PHARMS LLC Fresenius Kabi MARTEC USA LLC
Active Ingredient: DIAZEPAM
Website: ↗
DIAZEPAM Approval History
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What DIAZEPAM Treats
36 FDA approvalsOriginally approved for its first indication in 1985 . Covers 36 distinct patient populations.
- Other (36)
Other
(36 approvals)- • Approved indication (Sep 1985)
- • Approved indication (Sep 1985)
- • Approved indication (Nov 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Feb 1986)
- • Approved indication (Feb 1986)
- • Approved indication (Mar 1986)
- • Approved indication (Aug 1986)
- • Approved indication (Aug 1986)
- • Approved indication (Sep 1986)
- • Approved indication (Dec 1986)
- • Approved indication (Feb 1987)
- • Approved indication (Apr 1987)
- • Approved indication (Apr 1987)
- • Approved indication (Jul 1987)
- • Approved indication (Oct 1987)
- • Approved indication (Dec 1988)
- • Approved indication (Dec 1990)
- • Approved indication (Jan 1993)
- • Approved indication (Aug 1994)
- • Approved indication (Jan 2000)
- • Approved indication (Apr 2004)Letter
- • Approved indication (Mar 2006)
- • Approved indication (Apr 2014)
- • Approved indication (Jun 2016)
- • Approved indication (Mar 2019)
- • Approved indication (Dec 2019)Letter
- • Approved indication (Nov 2022)
- • Approved indication (May 2023)Letter
- • Approved indication (Dec 2023)
- • Approved indication (Apr 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Dec 2024)
- • Approved indication (May 2025) New
- • Approved indication (Nov 2025) NewLetter
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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.
DIAZEPAM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.