Data updated: Mar 10, 2026
MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE
Approved 2000-06-20
21
Indications
--
Phase 3 Trials
25
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2000-06-20
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, SYRUP
Companies
BEDFORD GLAND PHARMA LTD APOTHECON Pfizer Baxter PAI HOLDINGS INTL MEDICATION Hikma Sun Pharma PHARM ASSOC Fresenius Kabi IGI LABS INC BEN VENUE INTL MEDICATED PH HEALTH MICRO LABS PADAGIS US EPIC PHARMA LLC RISING
Active Ingredient: MIDAZOLAM HYDROCHLORIDE
Website: ↗
MIDAZOLAM HYDROCHLORIDE Approval History
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What MIDAZOLAM HYDROCHLORIDE Treats
21 FDA approvalsOriginally approved for its first indication in 2000 . Covers 21 distinct patient populations.
- Other (21)
Other
(21 approvals)- • Approved indication (Jun 2000)Letter
- • Approved indication (Jun 2000)Letter
- • Approved indication (Jun 2000)Letter
- • Approved indication (Oct 2000)Letter
- • Approved indication (Oct 2000)Letter
- • Approved indication (Nov 2000)Letter
- • Approved indication (Mar 2002)Letter
- • Approved indication (Apr 2002)Letter
- • Approved indication (Jun 2002)
- • Approved indication (Sep 2003)
- • Approved indication (Jul 2004)
- • Approved indication (Jan 2005)
- • Approved indication (May 2005)
- • Approved indication (Sep 2005)
- • Approved indication (May 2008)
- • Approved indication (Nov 2008)
- • Approved indication (Jan 2012)
- • Approved indication (Feb 2012)
- • Approved indication (Mar 2017)Label
- • Approved indication (Dec 2020)
- • Approved indication (Aug 2023)
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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.
MIDAZOLAM 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.