| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 218785 | NDA | BEONE MEDICINES USA | 001 | BRUKINSA | TABLET;ORAL | 160MG | ZANUBRUTINIB | 2025-06-10 | Prescription | Yes | |
| 002 | BRUKINSA | CAPSULE; ORAL | 80MG | ZANUBRUTINIB | 2025-06-10 | Prescription | No | ||||
| 213217 | NDA | BEONE MEDICINES USA | 001 | BRUKINSA | CAPSULE;ORAL | 80MG | ZANUBRUTINIB | 2019-11-14 | Discontinued | No |