LEVOCETIRIZINE DIHYDROCHLORIDE · TARO
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
Details
- Status
- Prescription
- First Approved
- 2007-05-25
- Routes
- ORAL
- Dosage Forms
- SOLUTION, TABLET
Companies
LEVOCETIRIZINE DIHYDROCHLORIDE Approval History
What LEVOCETIRIZINE DIHYDROCHLORIDE Treats
1 indicationsLEVOCETIRIZINE DIHYDROCHLORIDE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
LEVOCETIRIZINE DIHYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04699604 HAS3 | STUDY00001262 5R01HD100545-05 | Ph 3 | recruiting | A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3) |
| NCT00621959 results posted | A00430 | Ph 4 | completed | A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis |
| NCT01567501 | Ipca/ARL/059 | Ph 1 | completed | Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition |
| NCT00653224 results posted | A00431 | Ph 4 | completed | A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 DIHYDROCHLORIDE FDA Label Details
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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LEVOCETIRIZINE HYDROCHLORIDE
Full clinical data, patents, trials, and competitive landscape for levocetirizine dihydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.