Sold as Urispas. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 15, 2026, FDA lists 4 applications for Flavoxate Hydrochloride (sold as Urispas), first approved Jan 15, 1970, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Flavoxate HCl | Part D | $326K | -18% | 1,662 |
| Jan 15, 1970 | UrispasNDA 16769 · New molecular entity | Ortho Mcneil Janssen | 22 | Discontinued |
| Aug 28, 2003 | Flavoxate HydrochlorideANDA 76234 | Impax Pharms | 0 | Discontinued |
| Dec 16, 2004 | Flavoxate HydrochlorideANDA 76831 | Padagis US | 0 | Marketed |
| Nov 30, 2005 | Flavoxate HydrochlorideANDA 76835 | Epic Pharma | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
