Application 218785
- Type
- NDA
- Sponsor
- BEONE MEDICINES USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRUKINSA | ZANUBRUTINIB | TABLET;ORAL | 160MG | Yes | Yes |
| 002 | BRUKINSA | ZANUBRUTINIB | CAPSULE; ORAL | 80MG | No | No |