Drugs@FDA document
XYREM Letter · NDA 021196 SUPPL-39
Drugs@FDA document · JAZZ PHARMS · Feb 10, 2022
Key facts
| Drug name | XYREM |
|---|---|
| Document type | Letter |
| Application | NDA021196 |
| Submission | SUPPL-39 |
| Company | JAZZ PHARMS |
| Document date | Feb 10, 2022 |
At a glance
- REMS - MODIFIED - D-N-A 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: