Drugs@FDA document
PROCYSBI Pediatric Amendment 1 · NDA 203389 SUPPL-20
Drugs@FDA document · HORIZON · Oct 6, 2015
Key facts
| Drug name | PROCYSBI |
|---|---|
| Document type | Pediatric Amendment 1 |
| Application | NDA203389 |
| Submission | SUPPL-20 |
| Company | HORIZON |
| Document date | Oct 6, 2015 |
| 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: