Application 213721
- Type
- NDA
- Sponsor
- BLUEPRINT MEDICINES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GAVRETO | PRALSETINIB | CAPSULE;ORAL | 100MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50242-210 | Gavreto | Pralsetinib | Genentech, Inc. | NDA | Current |
| 50242-210 | Gavreto | Pralsetinib | Genentech, Inc. | NDA | Current |
| 50242-210 | Gavreto | Pralsetinib | Genentech, Inc. | NDA | Current |
| 50242-210 | Gavreto | Pralsetinib | Genentech, Inc. | NDA | Current |
| 72064-210 | GAVRETO | pralsetinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-210 | GAVRETO | pralsetinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-210 | GAVRETO | pralsetinib | Blueprint Medicines Corporation | NDA | Current |