Drugs@FDA document
OPUVIZ Review · BLA 761350 ORIG-1
Drugs@FDA document · Complete response letter · SAMSUNG BIOEPIS CO LTD · Oct 7, 2024
Key facts
| Drug name | OPUVIZ |
|---|---|
| Document type | Review |
| Application | BLA761350 |
| Submission | ORIG-1 |
| Company | SAMSUNG BIOEPIS CO LTD |
| Document date | Oct 7, 2024 |
| FDA document | accessdata.fda.gov |
At a glance
- Yes, flagged by Orca1 Complete response letter (CRL)
- Other Action Letters 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: