ZYRTEC ALLERGY (cetirizine hydrochloride) · KENVUE BRANDS
ZYRTEC ALLERGY is FDA-approved to treat 2 conditions (same as CETIRIZINE HYDROCHLORIDE).
Details
- Status
- Over-the-counter
- First Approved
- 1995-12-08
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING
ZYRTEC ALLERGY Approval History
What ZYRTEC ALLERGY Treats
2 indicationsZYRTEC ALLERGY is approved for 2 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Perennial allergic rhinitis
- Chronic idiopathic urticaria
Same approved indications as CETIRIZINE HYDROCHLORIDE (same active ingredient).
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.
ZYRTEC ALLERGY FDA Label Details
Indications & Usage
FDA Label (PDF)ZYRTEC ALLERGY is FDA-approved to treat 2 conditions — same approved indications as CETIRIZINE HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.