Application 214701
- Type
- NDA
- Sponsor
- BLUEPRINT MEDICINES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GAVRETO | PRALSETINIB | CAPSULE;ORAL | 100MG | 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 |
|---|---|---|---|---|---|---|
| Gavreto | PRALSETINIB | Rigel Pharmaceuticals, Inc. | 16edd46e-28b8-f06d-e063-6394a90ae31b | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | Gavreto PRALSETINIB |
| Gavreto | PRALSETINIB | Genentech, Inc. | 59984249-e3ff-4f97-8d7a-c1a905d604a8 | 2025-12-05 | Warnings, Adverse reactions | Gavreto PRALSETINIB |