Drugs@FDA document
MACRILEN Letter · NDA 205598 SUPPL-5
Drugs@FDA document · AETERNA ZENTARIS · Jul 27, 2026
Key facts
| Drug name | MACRILEN |
|---|---|
| Document type | Letter |
| Application | NDA205598 |
| Submission | SUPPL-5 |
| Company | AETERNA ZENTARIS |
| Document date | Jul 27, 2026 |
| FDA document | accessdata.fda.gov |
At a glance
- Efficacy-Labeling Change With Clinical Data 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: