Drug application
EPYSQLI (ECULIZUMAB-AAGH)
Drugs@FDA BLA 761340 · SAMSUNG BIOEPIS CO LTD
Key facts
| Drug name | EPYSQLI |
|---|---|
| Active ingredients | ECULIZUMAB-AAGH |
| Application type | BLA |
| Application number | 761340 |
| Company | SAMSUNG BIOEPIS CO LTD |
| Dosage forms | INJECTION, SOLUTION |
| Strength | 300 mg/30 mL (10 mg/mL) |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Efficacy |
| Latest submission status date | Nov 28, 2025 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: