Drugs@FDA document
GAZYVA Letter · BLA 125486 SUPPL-37
Drugs@FDA document · GENENTECH · Oct 21, 2025
Key facts
| Drug name | GAZYVA |
|---|---|
| Document type | Letter |
| Application | BLA125486 |
| Submission | SUPPL-37 |
| Company | GENENTECH |
| Document date | Oct 21, 2025 |
| FDA document | accessdata.fda.gov |
At a glance
- Efficacy-New Indication Document categories
- 10–99 Documents for this application
- 1–9 USP chapters cited in this application's documents
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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: