Drugs@FDA document
OPSYNVI Letter · NDA 218490 SUPPL-2
Drugs@FDA document · ACTELION · Apr 8, 2025
Key facts
| Drug name | OPSYNVI |
|---|---|
| Document type | Letter |
| Application | NDA218490 |
| Submission | SUPPL-2 |
| Company | ACTELION |
| Document date | Apr 8, 2025 |
At a glance
- REMS - MODIFIED - D-N-A Document categories
- 10–99 Documents for this application
- 1–9 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: