Application 761456
- Type
- BLA
- Sponsor
- AMNEAL PHARMS LLC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761456 | Boncresa | denosumab-mobz | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BONCRESA | DENOSUMAB-MOBZ | INJECTABLE;SUBCUTANEOUS | 60MG/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 |
|---|---|---|---|---|---|---|
| Boncresa | DENOSUMAB-MOBZ | Amneal Pharmaceuticals LLC | 29140df2-24a3-4a6f-a8e3-065521448d61 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | BLA761456 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.