XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) · CHATTEM SANOFI
XYZAL ALLERGY 24HR is FDA-approved to treat 1 condition (same as LEVOCETIRIZINE DIHYDROCHLORIDE).
Details
- Status
- Over-the-counter
- First Approved
- 2017-01-31
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
XYZAL ALLERGY 24HR Approval History
What XYZAL ALLERGY 24HR Treats
1 indicationsXYZAL ALLERGY 24HR is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as LEVOCETIRIZINE DIHYDROCHLORIDE (same active ingredient).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04699604 HAS3 | STUDY00001262 5R01HD100545-05 | Ph 3 | completed | 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.
XYZAL ALLERGY 24HR FDA Label Details
Indications & Usage
FDA Label (PDF)XYZAL ALLERGY 24HR is FDA-approved to treat 1 condition — same approved indications as LEVOCETIRIZINE DIHYDROCHLORIDE.
XYZAL ALLERGY 24HR Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for XYZAL ALLERGY 24HR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.