PROVENTIL-HFA
Details
- Status
- Prescription
- First Approved
- 1996-08-15
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
PROVENTIL-HFA Approval History
What PROVENTIL-HFA Treats
3 indicationsPROVENTIL-HFA is approved for 3 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Obstructive Airway Disease
- Exercise-Induced Bronchospasm
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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.
PROVENTIL-HFA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for t...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.