BEQALZI
NDA 220711 · New Drug Application (NDA) Prescription
SONROTOCLAX
- Sponsor (Drugs@FDA)
- BEONE MEDICINES USA Company: BeOne Medicines Ltd. (ONC, BEIGF)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | BEQALZI SONROTOCLAX | TABLET;ORAL 1MG | Prescription | – | Reference listed drug | RXApproved |
| 002 | BEQALZI SONROTOCLAX | TABLET;ORAL 5MG | Prescription | – | Reference listed drug | RXApproved |
| 003 | BEQALZI SONROTOCLAX | TABLET;ORAL 20MG | Prescription | – | Reference listed drug, Reference standard | RXApproved |
| 004 | BEQALZI SONROTOCLAX | TABLET;ORAL 80MG | Prescription | – | Reference listed drug | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
4 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 11420968Product 001 | Drug substance, Drug product | – | ||
| 11420968Product 002 | Drug substance, Drug product | – | ||
| 11420968Product 003 | Drug substance, Drug product | – | ||
| 11420968Product 004 | Drug substance, Drug product | – |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 | |
| NCE | 002 | |
| NCE | 003 | |
| NCE | 004 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
5 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 72579-015 in openFDA (opens in a new tab) | BEQALZI sonrotoclax | BeOne Medicines USA, Inc. | KIT | NDA | From |
| 72579-017 in openFDA (opens in a new tab) | BEQALZI sonrotoclax | BeOne Medicines USA, Inc. | TABLET, FILM COATED ORAL | NDA | From |
| 72579-020 in openFDA (opens in a new tab) | BEQALZI sonrotoclax | BeOne Medicines USA, Inc. | TABLET, FILM COATED ORAL | NDA | From |
| 72579-022 in openFDA (opens in a new tab) | BEQALZI sonrotoclax | BeOne Medicines USA, Inc. | TABLET, FILM COATED ORAL | NDA | From |
| 72579-025 in openFDA (opens in a new tab) | BEQALZI sonrotoclax | BeOne Medicines USA, Inc. | TABLET, FILM COATED ORAL | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.