Drugs@FDA document
ISTURISA Label · NDA 212801 SUPPL-7
Drugs@FDA document · RECORDATI RARE · Jul 2, 2026
Key facts
| Drug name | ISTURISA |
|---|---|
| Document type | Label |
| Application | NDA212801 |
| Submission | SUPPL-7 |
| Company | RECORDATI RARE |
| Document date | Jul 2, 2026 |
| FDA document | accessdata.fda.gov |
At a glance
- Manufacturing (CMC)-Manufacturing Process 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: