Skip to contentApplication 217729
- Type
- NDA
- Sponsor
- PF PRISM CV
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BOSULIF | BOSUTINIB MONOHYDRATE | CAPSULE;ORAL | EQ 50MG BASE | Yes | No |
| 002 | BOSULIF | BOSUTINIB MONOHYDRATE | CAPSULE;ORAL | EQ 100MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85288 | SUPPL | 2026-03-06 |
| 85265 | SUPPL | 2026-03-04 |
| 80523 | SUPPL | 2024-12-05 |
| 80503 | SUPPL | 2024-12-04 |
| 77635 | ORIG | 2024-02-28 |
| 75573 | ORIG | 2023-09-27 |
| 75571 | ORIG | 2023-09-27 |