FdaApplication
BLA 761059
Identifiers
- fda_app_no: BLA761059
Properties
| Property | Value |
|---|---|
| applicant_name | Samsung Bioepis Co., Ltd. |
| application_type | BLA |
| approval_date | 2019-07-23 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HADLIMA | ADALIMUMAB-BWWD | 40MG/0.8ML | Injection |
| HADLIMA | — | 40MG/0.4ML | Injection |
| HADLIMA | — | 40MG/0.8ML | Injection |
| HADLIMA | — | 40MG/0.8ML | Injection |
| HADLIMA | — | 40MG/0.4ML | Injection |
| HADLIMA | — | 80MG/0.8ML | Injection |
6 products