Drugs@FDA document
KALYDECO Letter · NDA 203188 SUPPL-41
Drugs@FDA document · VERTEX PHARMS · May 27, 2025
Key facts
| Drug name | KALYDECO |
|---|---|
| Document type | Letter |
| Application | NDA203188 |
| Submission | SUPPL-41 |
| Company | VERTEX PHARMS |
| Document date | May 27, 2025 |
| FDA document | accessdata.fda.gov |
At a glance
- Efficacy-Labeling Change With Clinical Data 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: