FdaApplication
BLA 761439
Identifiers
- fda_app_no: BLA761439
Properties
| Property | Value |
|---|---|
| applicant_name | Hikma Pharmaceuticals USA Inc. |
| application_type | BLA |
| approval_date | 2025-09-26 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ENOBY | DENOSUMAB-QBDE | 60MG/ML | Injection |
| XTRENBO | DENOSUMAB-QBDE | 120MG/1.7ML (70MG/ML) | Injection |
2 products