Application 761439
- Type
- BLA
- Sponsor
- HIKMA PHARMACEUTICALS USA INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761439 | Enoby | denosumab-qbde | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
| 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ENOBY | DENOSUMAB-QBDE | Hikma Pharmaceuticals USA Inc. | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | BLA761439 |
| XTRENBO | DENOSUMAB-QBDE | Hikma Pharmaceuticals USA Inc. | a48a3a33-6b0e-4cf4-8786-8f662d6ee77b | 2025-09-02 | Warnings, Adverse reactions | BLA761439 |