Drugs@FDA document
QDOLO REMS · NDA 214044 ORIG-1
Drugs@FDA document · ROSEMONT PHARMACEUTICALS LLC · Nov 7, 2023
Key facts
| Drug name | QDOLO |
|---|---|
| Document type | REMS |
| Application | NDA214044 |
| Submission | ORIG-1 |
| Company | ROSEMONT PHARMACEUTICALS LLC |
| Document date | Nov 7, 2023 |
| FDA document | web.archive.org |
At a glance
- 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: