Drugs@FDA document
BRUKINSA Letter · NDA 218785 ORIG-2
Drugs@FDA document · BEONE MEDICINES USA · Jun 12, 2025
Key facts
| Drug name | BRUKINSA |
|---|---|
| Document type | Letter |
| Application | NDA218785 |
| Submission | ORIG-2 |
| Company | BEONE MEDICINES USA |
| Document date | Jun 12, 2025 |
| FDA document | accessdata.fda.gov |
At a glance
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About Drugs@FDA documents
Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date: