Drugs@FDA document
KUVAN Letter · NDA 205065 SUPPL-5
Drugs@FDA document · BIOMARIN PHARM · May 3, 2019
Key facts
| Drug name | KUVAN |
|---|---|
| Document type | Letter |
| Application | NDA205065 |
| Submission | SUPPL-5 |
| Company | BIOMARIN PHARM |
| Document date | May 3, 2019 |
At a glance
- Labeling-Package Insert, Labeling-Patient Package Insert 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: