Data updated: Mar 10, 2026
HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE
Approved 1979-08-24
45
Indications
--
Phase 3 Trials
46
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1979-08-24
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE, SYRUP
Companies
WATSON LABS Baxter Pfizer SOLOPAK KV PHARM PLIVA PHARMAFAIR APOZEAL PHARMS EPIC PHARMA LLC IVAX PHARMS Sun Pharma QUANTUM PHARMICS SUPERPHARM USL PHARMA PRINSTON INC Novartis Teva HALSEY BIONPHARMA PAI HOLDINGS PHARM Dr. Reddy's STRIDES PHARMA INTL MUTUAL PHARM HERITAGE NORTHSTAR HLTHCARE PUREPAC PHARM LANNETT CO INC NOVITIUM PHARMA AMNEAL PHARM RISING AM REGENT CHARTWELL RX HETERO LABS LTD III SOMERSET THERAPS LLC ALTANA Hikma Aurobindo Pharma ALPHARMA US PHARMS ABLE Fresenius Kabi GRAVITI PHARMS KVK TECH SMITH AND NEPHEW NUVO PHARMS INC
Active Ingredient: HYDROXYZINE HYDROCHLORIDE
Website: ↗
HYDROXYZINE HYDROCHLORIDE Approval History
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What HYDROXYZINE HYDROCHLORIDE Treats
45 FDA approvalsOriginally approved for its first indication in 1979 . Covers 45 distinct patient populations.
- Other (45)
Other
(45 approvals)- • Approved indication (Aug 1979)
- • Approved indication (Sep 1979)
- • Approved indication (Oct 1979)
- • Approved indication (Jul 1980)
- • Approved indication (Mar 1981)
- • Approved indication (Apr 1981)
- • Approved indication (May 1981)
- • Approved indication (Jun 1981)
- • Approved indication (Jul 1981)
- • Approved indication (Aug 1981)
- • Approved indication (Aug 1981)
- • Approved indication (Jan 1982)
- • Approved indication (Apr 1982)
- • Approved indication (Jun 1982)
- • Approved indication (Dec 1982)
- • Approved indication (Mar 1983)
- • Approved indication (Apr 1983)
- • Approved indication (Sep 1983)
- • Approved indication (Nov 1983)
- • Approved indication (Dec 1984)
- • Approved indication (Jan 1986)
- • Approved indication (May 1986)
- • Approved indication (May 1988)
- • Approved indication (Mar 1994)
- • Approved indication (Oct 1994)
- • Approved indication (Sep 1995)
- • Approved indication (Apr 2002)Letter
- • Approved indication (Jul 2004)
- • Approved indication (Dec 2004)
- • Approved indication (May 2005)
- • Approved indication (Mar 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Mar 2008)
- • Approved indication (May 2008)
- • Approved indication (Jun 2008)
- • Approved indication (Jun 2008)
- • Approved indication (Sep 2008)
- • Approved indication (Jun 2010)
- • Approved indication (Aug 2013)
- • Approved indication (Aug 2014)
- • Approved indication (Mar 2017)
- • Approved indication (Feb 2019)
- • Approved indication (Aug 2023)
- • Approved indication (Apr 2025) New
- • 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.
HYDROXYZINE 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.