Application 761439
- Type
- BLA
- Sponsor
- HIKMA PHARMACEUTICALS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENOBY | DENOSUMAB-QBDE | SOLUTION;INJECTION | 60MG/ML | No | No |
| 002 | XTRENBO | DENOSUMAB-QBDE | SOLUTION;INJECTION | 120MG/1.7ML(70MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84974 | ORIG | 2026-02-10 |
| 84973 | ORIG | 2026-02-10 |
| 84025 | ORIG | 2025-10-31 |
| 84024 | ORIG | 2025-10-31 |
| 84012 | ORIG | 2025-10-31 |
| 83601 | ORIG | 2025-09-30 |
| 83570 | ORIG | 2025-09-26 |