Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220711
Company: BEONE MEDICINES USA
Company: BEONE MEDICINES USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEQALZI | SONROTOCLAX | 1MG | TABLET; ORAL | Prescription | None | No | No |
| BEQALZI | SONROTOCLAX | 5MG | TABLET; ORAL | Prescription | None | No | No |
| BEQALZI | SONROTOCLAX | 20MG | TABLET; ORAL | Prescription | None | No | No |
| BEQALZI | SONROTOCLAX | 80MG | TABLET; 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 |
|---|---|---|---|---|---|---|---|
| 05/13/2026 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220711Orig1s000ltr.pdf |