BUSPIRONE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2001-03-28
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
BUSPIRONE HYDROCHLORIDE Approval History
What BUSPIRONE HYDROCHLORIDE Treats
2 indicationsBUSPIRONE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety Disorders
- Generalized Anxiety Disorder
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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.
BUSPIRONE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presen...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.