Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218785
Company: BEONE MEDICINES USA
Company: BEONE MEDICINES USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRUKINSA | ZANUBRUTINIB | 160MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| BRUKINSA | ZANUBRUTINIB | 80MG | CAPSULE; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/10/2025 | ORIG-2 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218785Original2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218785Orig2s000ltr.pdf | |
| 06/10/2025 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218785Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218785Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/10/2025 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218785Original2s000lbl.pdf | |
| 06/10/2025 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218785Orig1s000lbl.pdf |