FdaApplication
BLA 125738
Identifiers
- fda_app_no: BLA125738
Properties
| Property | Value |
|---|---|
| applicant_name | Gamida Cell Ltd. |
| application_type | BLA |
| approval_date | 2023-04-17 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OMISIRGE | — | >4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol; >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so | For Injection |
1 product