Data updated: Mar 10, 2026
ALPRAZOLAM
ALPRAZOLAM
Approved 1993-10-19
32
Indications
--
Phase 3 Trials
32
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1993-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, CONCENTRATE, TABLET, ORALLY DISINTEGRATING, SOLUTION
Companies
PHARMOBEDIENT ANI PHARMS AMNEAL PHARMS NY Hikma Apotex HERITAGE PHARMS INC CHARTWELL RX PH HEALTH Novartis Teva Aurobindo Pharma WATSON LABS NOVITIUM PHARMA IVAX SUB TEVA PHARMS ROXANE OXFORD PHARMS Sun Pharma STRIDES PHARMA INTL NATCO IMPAX LABS IMPAX LABS INC Viatris
Active Ingredient: ALPRAZOLAM
Website: ↗
ALPRAZOLAM Approval History
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What ALPRAZOLAM Treats
32 FDA approvalsOriginally approved for its first indication in 1993 . Covers 32 distinct patient populations.
- Other (32)
Other
(32 approvals)- • Approved indication (Oct 1993)
- • Approved indication (Oct 1993)
- • Approved indication (Jan 1994)
- • Approved indication (Feb 1994)
- • Approved indication (Jul 1994)
- • Approved indication (Aug 1995)
- • Approved indication (Dec 1995)
- • Approved indication (Jan 1997)
- • Approved indication (Mar 1998)
- • Approved indication (Jan 2006)Letter
- • Approved indication (Jun 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Jan 2007)
- • Approved indication (Jan 2007)
- • Approved indication (Feb 2007)
- • Approved indication (Feb 2007)
- • Approved indication (May 2007)
- • Approved indication (Oct 2007)
- • Approved indication (May 2008)
- • Approved indication (Sep 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Nov 2008)
- • Approved indication (Jan 2009)Letter
- • Approved indication (Mar 2010)
- • Approved indication (May 2010)
- • Approved indication (Jun 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Jun 2011)
- • Approved indication (Sep 2011)
- • Approved indication (Apr 2015)
- • Approved indication (Jul 2015)
- • Approved indication (Jul 2018)
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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.
ALPRAZOLAM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.