Data updated: Mar 10, 2026
MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE
Approved 1975-03-19
29
Indications
--
Phase 3 Trials
50
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1975-03-19
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, CHEWABLE
Companies
VANGARD UDL SUPERPHARM ANI PHARMS RISING JUBILANT CADISTA SENORES PHARMS PLIVA HERITAGE ABC HOLDING NEXGEN PHARMA INC CHARTWELL RX IVAX SUB TEVA PHARMS SCIEGEN PHARMS KV PHARM ANABOLIC INVAGEN PHARMS BUNDY WATSON LABS AMNEAL PHARMS ZYDUS LIFESCIENCES Novartis STRIDES PHARMA INTL EPIC PHARMA LLC Aurobindo Pharma
Active Ingredient: MECLIZINE HYDROCHLORIDE
Website: ↗
MECLIZINE HYDROCHLORIDE Approval History
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What MECLIZINE HYDROCHLORIDE Treats
29 FDA approvalsOriginally approved for its first indication in 1975 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Mar 1975)
- • Approved indication (Dec 1975)
- • Approved indication (Dec 1975)
- • Approved indication (Feb 1976)
- • Approved indication (Oct 1976)
- • Approved indication (Nov 1976)
- • Approved indication (Feb 1977)
- • Approved indication (Feb 1977)
- • Approved indication (Jun 1977)
- • Approved indication (Jun 1977)
- • Approved indication (Jul 1977)
- • Approved indication (May 1978)
- • Approved indication (Jul 1978)
- • Approved indication (Sep 1978)
- • Approved indication (Jun 1981)
- • Approved indication (Jan 1982)
- • Approved indication (Apr 1982)
- • Approved indication (Aug 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Mar 1988)
- • Approved indication (Jan 1997)
- • Approved indication (Jun 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Apr 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Feb 2019)
- • Approved indication (Jun 2020)
- • Approved indication (Feb 2022)
- • Approved indication (Aug 2022)
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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.
MECLIZINE 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.