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Data updated: Mar 10, 2026

LEVOCETIRIZINE HYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE
Respiratory Approved 2019-04-01
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-04-01
Routes
ORAL
Dosage Forms
SOLUTION

Companies

HETERO LABS LTD III
Active Ingredient: LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE HYDROCHLORIDE Approval History

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What LEVOCETIRIZINE HYDROCHLORIDE Treats

1 indications

LEVOCETIRIZINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hay Fever
Source: FDA Label

Drugs Similar to LEVOCETIRIZINE HYDROCHLORIDE

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ENCUBE
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FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
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KOVANAZE
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LEVOCETIRIZINE DIHYDROCHLORIDE
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RHINOCORT
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KENVUE BRANDS
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

LEVOCETIRIZINE HYDROCHLORIDE FDA Label Details

Pro

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

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Data Sources

FDA Approval: ANDA210914 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.