Data updated: Mar 10, 2026
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
CETIRIZINE HYDROCHLORIDE
Approved 2008-02-14
19
Indications
--
Phase 3 Trials
18
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-02-14
- Routes
- ORAL
- Dosage Forms
- TABLET, CHEWABLE, SOLUTION
Companies
Sun Pharma TRIS PHARMA INC PERRIGO R AND D RANBAXY LABS LTD PHARM ASSOC AMNEAL PHARMS CHARTWELL RX APOZEAL PHARMS TARO CYPRESS PHARM HETERO LABS LTD III Novartis Aurobindo Pharma JUBILANT GENERICS CHARTWELL MOLECULAR BAJAJ NOVEL LABS INC QUAGEN
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Website: ↗
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY Approval History
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What CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY Treats
19 FDA approvalsOriginally approved for its first indication in 2008 . Covers 19 distinct patient populations.
- Other (19)
Other
(19 approvals)- • Approved indication (Feb 2008)
- • Approved indication (Apr 2008)Letter
- • Approved indication (Apr 2008)
- • Approved indication (Apr 2008)
- • Approved indication (May 2008)
- • Approved indication (Oct 2008)Letter
- • Approved indication (Mar 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Feb 2010)
- • Approved indication (Apr 2011)
- • Approved indication (May 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Nov 2012)
- • Approved indication (Sep 2013)
- • Approved indication (Feb 2015)
- • Approved indication (Mar 2016)
- • Approved indication (Mar 2019)
- • Approved indication (May 2019)Label
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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.
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.