XOPENEX (levalbuterol hydrochloride) · Hikma
XOPENEX is FDA-approved to treat 2 conditions (same as LEVALBUTEROL HYDROCHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 1999-03-25
- Routes
- INHALATION
- Dosage Forms
- SOLUTION
XOPENEX Approval History
What XOPENEX Treats
2 indicationsXOPENEX is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Obstructive Airway Disease
Same approved indications as LEVALBUTEROL 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.
XOPENEX FDA Label Details
Indications & Usage
FDA Label (PDF)XOPENEX is FDA-approved to treat 2 conditions — same approved indications as LEVALBUTEROL HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.