Drugs@FDA document
SIMPONI Letter · BLA 125289 SUPPL-153
Drugs@FDA document · CENTOCOR ORTHO BIOTECH INC · Nov 17, 2023
Key facts
| Drug name | SIMPONI |
|---|---|
| Document type | Letter |
| Application | BLA125289 |
| Submission | SUPPL-153 |
| Company | CENTOCOR ORTHO BIOTECH INC |
| Document date | Nov 17, 2023 |
| FDA document | accessdata.fda.gov |
At a glance
- Labeling-Package Insert 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: