Application 761362
- Type
- BLA
- Sponsor
- SANDOZ INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761362 | Jubbonti | denosumab-bbdz | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | JUBBONTI | DENOSUMAB-BBDZ | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
| 002 | WYOST | DENOSUMAB-BBDZ | INJECTABLE;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|
| WYOST | DENOSUMAB | Sandoz Inc | 69e4890d-5dd9-42a5-aa41-ce50635eaed7 | 2026-02-20 | Warnings, Adverse reactions | BLA761362 |
| JUBBONTI | DENOSUMAB | Sandoz Inc | 4bf239bb-c467-4add-b7cf-ea666e4fc693 | 2025-10-30 | Boxed warning, Warnings, Adverse reactions | BLA761362 |