Drugs@FDA document
COTEMPLA XR-ODT Label · NDA 205489 SUPPL-16
Drugs@FDA document · NEOS THERAPS INC · May 6, 2024
Key facts
| Drug name | COTEMPLA XR-ODT |
|---|---|
| Document type | Label |
| Application | NDA205489 |
| Submission | SUPPL-16 |
| Company | NEOS THERAPS INC |
| Document date | May 6, 2024 |
| FDA document | accessdata.fda.gov |
At a glance
- Manufacturing (CMC)-Control 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: