Sold as Femstat, Butoconazole Nitrate, Femstat 3. Every FDA application for this active ingredient: 4 branded and 1 generic.
As of Nov 15, 2026, FDA lists 5 applications for Butoconazole Nitrate (sold as Femstat, Butoconazole Nitrate, Femstat 3), first approved Dec 21, 1995, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Gynazole 1 | Part D | $55K | -5% | 176 |
| Dec 21, 1995 | Femstat 3NDA 20421 · New dosage form | Bayer | 2 | Discontinued |
| Feb 7, 1997 | Butoconazole NitrateNDA 19881 · New dosage form | Padagis US | 7 | Discontinued |
| May 18, 2012 | Gynazole-1ANDA 200923 | Padagis Israel | 1 | Marketed |
| — | FemstatNDA 19215 | Roche Palo | 0 | Discontinued |
| — | FemstatNDA 19359 | Roche Palo | 0 | Discontinued |
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
Bayer