TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

FLAVOXATE HYDROCHLORIDE

FLAVOXATE HYDROCHLORIDE
Infectious Disease Approved 2003-08-28
3
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-08-28
Routes
ORAL
Dosage Forms
TABLET

FLAVOXATE HYDROCHLORIDE Approval History

Loading approval history...

What FLAVOXATE HYDROCHLORIDE Treats

9 indications

FLAVOXATE 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
Source: FDA Label
๐Ÿ”ฌ

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
โญ

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
๐Ÿ“Š

Trial Timeline

Full development history with FDA approval milestones

Loading...
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

Pro

Indications & 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.

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.