Drugs@FDA document
ENJAYMO Letter · BLA 761164 SUPPL-3
Drugs@FDA document · RECORDATI RARE DISEASES, INC. · Jan 26, 2023
Key facts
| Drug name | ENJAYMO |
|---|---|
| Document type | Letter |
| Application | BLA761164 |
| Submission | SUPPL-3 |
| Company | RECORDATI RARE DISEASES, INC. |
| Document date | Jan 26, 2023 |
| FDA document | accessdata.fda.gov |
At a glance
- Efficacy-New Indication Document categories
- 10–99 Documents for this application
- None 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: