Drugs@FDA document
IBTROZI Label · NDA 219713 SUPPL-4
Drugs@FDA document · NUVATION · Sep 22, 2026
Key facts
| Drug name | IBTROZI |
|---|---|
| Document type | Label |
| Application | NDA219713 |
| Submission | SUPPL-4 |
| Company | NUVATION |
| Document date | Sep 22, 2026 |
| FDA document | accessdata.fda.gov |
At a glance
- Efficacy-Labeling Change With Clinical Data Document categories
- 1–9 Documents for this application
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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: