Data updated: Mar 10, 2026
HALOPERIDOL
HALOPERIDOL
Approved 1986-06-10
37
Indications
--
Phase 3 Trials
39
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1986-06-10
- Routes
- ORAL, INJECTION, Injection
- Dosage Forms
- TABLET, INJECTABLE, CONCENTRATE, Injectable
Companies
SCS WATSON LABS PUREPAC PHARM INNOGENIX CHARTWELL RX VINTAGE LEDERLE Baxter SAGENT PHARMS Viatris SMITH AND NEPHEW AIPING PHARM INC DURAMED PHARMS BARR Hikma FOSUN PHARMA Teva MSN CREEKWOOD PHARMS SOLOPAK Novartis ROYCE LABS LANNETT CO INC Fresenius Kabi MORTON GROVE QUANTUM PHARMICS MANKIND PHARMA RUBICON RESEARCH ALPHARMA GLAND PHARMA LTD EPIC PHARMA LLC MARSAM PHARMS LLC APPCO Aurobindo Pharma PHARM ASSOC PAR PHARM ZYDUS PHARMS USA QUAD PHARMS ABRAXIS PHARM STRIDES PHARMA INTL
Active Ingredient: HALOPERIDOL
Website: ↗
HALOPERIDOL Approval History
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What HALOPERIDOL Treats
37 FDA approvalsOriginally approved for its first indication in 1986 . Covers 37 distinct patient populations.
- Other (37)
Other
(37 approvals)- • Approved indication (Jun 1986)
- • Approved indication (Nov 1986)
- • Approved indication (Nov 1986)
- • Approved indication (Dec 1986)
- • Approved indication (Jan 1987)
- • Approved indication (Feb 1987)
- • Approved indication (Mar 1987)
- • Approved indication (May 1987)
- • Approved indication (Jul 1987)
- • Approved indication (Jul 1987)
- • Approved indication (Aug 1987)
- • Approved indication (Aug 1987)
- • Approved indication (Jan 1988)
- • Approved indication (Mar 1988)
- • Approved indication (May 1988)
- • Approved indication (Dec 1988)
- • Approved indication (Aug 1991)
- • Approved indication (Feb 1993)
- • Approved indication (Feb 1993)
- • Approved indication (Sep 1993)
- • Approved indication (Mar 2001)Letter
- • Approved indication (Jun 2001)Letter
- • Approved indication (Aug 2001)Letter
- • Approved indication (Aug 2004)
- • Approved indication (Sep 2004)
- • Approved indication (Nov 2007)
- • Approved indication (Sep 2009)
- • Approved indication (Sep 2011)
- • Approved indication (Sep 2017)Letter
- • Approved indication (Jul 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Jul 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Jan 2024)
- • Approved indication (Apr 2024)
- • Approved indication (Apr 2024)
- • Approved indication (Dec 2025) New
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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.
HALOPERIDOL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.