Drugs@FDA document
MYALEPT Letter · BLA 125390 SUPPL-12
Drugs@FDA document · CHIESI FARMACEUTICI SPA · Dec 18, 2017
Key facts
| Drug name | MYALEPT |
|---|---|
| Document type | Letter |
| Application | BLA125390 |
| Submission | SUPPL-12 |
| Company | CHIESI FARMACEUTICI SPA |
| Document date | Dec 18, 2017 |
| FDA document | accessdata.fda.gov |
At a glance
- REMS - MODIFIED - D-N-A Document categories
- 10–99 Documents for this application
- 1–9 USP chapters cited in this application's documents
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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: