Drugs@FDA document
KADCYLA Letter · BLA 125427 SUPPL-105
Drugs@FDA document · GENENTECH · May 6, 2019
Key facts
| Drug name | KADCYLA |
|---|---|
| Document type | Letter |
| Application | BLA125427 |
| Submission | SUPPL-105 |
| Company | GENENTECH |
| Document date | May 6, 2019 |
| FDA document | accessdata.fda.gov |
At a glance
- Efficacy-Manufacturing Change With Clinical Data Document categories
- 10–99 Documents for this application
- None USP chapters cited in this application's documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: