FLAVOXATE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2003-08-28
- Routes
- ORAL
- Dosage Forms
- TABLET
FLAVOXATE HYDROCHLORIDE Approval History
What FLAVOXATE HYDROCHLORIDE Treats
9 indicationsFLAVOXATE HYDROCHLORIDE is approved for 9 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dysuria
- Urgency
- Nocturia
- Suprapubic Pain
- Incontinence
- Cystitis
- Prostatitis
- Urethritis
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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.
FLAVOXATE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Flavoxate HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.