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Application 217581
- Type
- NDA
- Sponsor
- PF PRISM CV
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XALKORI | CRIZOTINIB | CAPSULE, PELLETS;ORAL | 20MG | Yes | No |
| 002 | XALKORI | CRIZOTINIB | CAPSULE, PELLETS;ORAL | 50MG | Yes | No |
| 003 | XALKORI | CRIZOTINIB | CAPSULE, PELLETS;ORAL | 150MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80847 | ORIG | 2025-01-14 |
| 80846 | ORIG | 2025-01-14 |
| 75376 | ORIG | 2023-09-08 |
| 75373 | ORIG | 2023-09-07 |