Data updated: Mar 10, 2026
LORAZEPAM
LORAZEPAM
Approved 1985-12-10
35
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1985-12-10
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE, SOLUTION, CONCENTRATE
Companies
USL PHARMA WATSON LABS Novartis SUPERPHARM Pfizer ROXANE PH HEALTH INTL MEDICATION SYS AMNEAL PHARMS PHARM ASSOC Hikma Aurobindo Pharma AM THERAP HALSEY EPIC PHARMA LLC RISING WARNER CHILCOTT CAPLIN Sun Pharma ANI PHARMS CHARTWELL MOLECULAR PAR PHARM Lupin BEDFORD TP ANDA HOLDINGS LEADING MUTUAL PHARM GRAVITI PHARMS CHARTWELL RX PHARMOBEDIENT OXFORD PHARMS Fresenius Kabi
Active Ingredient: LORAZEPAM
Website: ↗
LORAZEPAM Approval History
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What LORAZEPAM Treats
35 FDA approvalsOriginally approved for its first indication in 1985 . Covers 35 distinct patient populations.
- Other (35)
Other
(35 approvals)- • Approved indication (Dec 1985)
- • Approved indication (Jul 1986)
- • Approved indication (Mar 1987)
- • Approved indication (Apr 1987)
- • Approved indication (Oct 1987)
- • Approved indication (Jan 1988)
- • Approved indication (Apr 1988)
- • Approved indication (Mar 1991)
- • Approved indication (Oct 1991)
- • Approved indication (Apr 1994)
- • Approved indication (Apr 1994)
- • Approved indication (May 1994)
- • Approved indication (Sep 1996)
- • Approved indication (Mar 1997)
- • Approved indication (Jul 1998)
- • Approved indication (Sep 1998)Label Letter
- • Approved indication (Mar 2000)Label Letter
- • Approved indication (Aug 2001)Letter
- • Approved indication (Nov 2004)
- • Approved indication (Jul 2005)
- • Approved indication (Mar 2006)
- • Approved indication (May 2006)
- • Approved indication (Dec 2006)
- • Approved indication (Jul 2007)
- • Approved indication (Apr 2009)Label Letter
- • Approved indication (Dec 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Jun 2010)
- • Approved indication (Jan 2012)
- • Approved indication (Feb 2013)
- • Approved indication (Apr 2017)
- • Approved indication (Apr 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Nov 2024)
- • Approved indication (Jul 2025) New
🔬
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.
LORAZEPAM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.