Drugs@FDA document
PROCYSBI Letter · NDA 203389 SUPPL-27
Drugs@FDA document · HORIZON · Feb 15, 2022
Key facts
| Drug name | PROCYSBI |
|---|---|
| Document type | Letter |
| Application | NDA203389 |
| Submission | SUPPL-27 |
| Company | HORIZON |
| Document date | Feb 15, 2022 |
At a glance
- Labeling-Package Insert, Labeling-Patient 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: