Application 217439
- Type
- NDA
- Sponsor
- PFIZER
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.1MG BASE | Yes | No |
| 002 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.25MG BASE | Yes | No |
| 003 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.35MG BASE | Yes | No |
| 004 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.5MG BASE | Yes | No |
| 005 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.75MG BASE | Yes | No |
| 006 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 1MG BASE | Yes | Yes |
Documents
| Document | Submission type | Date |
|---|
| 82571 | SUPPL | 2025-06-13 |
| 82562 | SUPPL | 2025-06-13 |
| 79802 | ORIG | 2024-10-03 |
| 77769 | ORIG | 2024-03-08 |
| 77762 | ORIG | 2024-03-08 |