Drugs@FDA document
DULERA Letter · NDA 022518 SUPPL-4
Drugs@FDA document · ORGANON LLC · Aug 22, 2011
Key facts
| Drug name | DULERA |
|---|---|
| Document type | Letter |
| Application | NDA022518 |
| Submission | SUPPL-4 |
| Company | ORGANON LLC |
| Document date | Aug 22, 2011 |
| FDA document | accessdata.fda.gov |
At a glance
- Labeling-Package Insert 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: