Application 204369
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STIVARGA | REGORAFENIB | TABLET; ORAL | 40MG | Yes | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Stivarga | REGORAFENIB | Bayer HealthCare Pharmaceuticals Inc. | 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | Stivarga REGORAFENIB |