Data updated: Mar 10, 2026
CETIRIZINE HYDROCHLORIDE ALLERGY
CETIRIZINE HYDROCHLORIDE
Approved 2007-12-27
21
Indications
--
Phase 3 Trials
18
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2007-12-27
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING, CAPSULE, TABLET, CHEWABLE
Companies
Sun Pharma Aurobindo Pharma PLD ACQUISITIONS MARKSANS PHARMA PERRIGO R AND D BIONPHARMA TORRENT PHARMS LLC CATALENT ORBION PHARMS Apotex GRANULES GLENMARK PHARMS INC AIPING PHARM INC Cipla CONTRACT PHARMACAL Viatris AMNEAL PHARMS NY HERITAGE PHARMA UNICHEM UNIQUE TARO Dr. Reddy's ONESOURCE SPECIALTY
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Website: ↗
CETIRIZINE HYDROCHLORIDE ALLERGY Approval History
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What CETIRIZINE HYDROCHLORIDE ALLERGY Treats
21 FDA approvalsOriginally approved for its first indication in 2007 . Covers 21 distinct patient populations.
- Other (21)
Other
(21 approvals)- • Approved indication (Dec 2007)Label Letter
- • Approved indication (Dec 2007)Label Letter
- • Approved indication (Jan 2008)Label Letter
- • Approved indication (Jan 2008)Label Letter
- • Approved indication (Feb 2009)
- • Approved indication (Jun 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Aug 2009)
- • Approved indication (Jan 2010)Letter
- • Approved indication (Apr 2010)Letter
- • Approved indication (Jun 2010)
- • Approved indication (Jul 2013)
- • Approved indication (Mar 2014)
- • Approved indication (Aug 2015)
- • Approved indication (Sep 2015)Label Letter
- • Approved indication (Aug 2016)Letter
- • Approved indication (Jul 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Jul 2018)Letter
- • Approved indication (Sep 2020)
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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.
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.