Application 761392
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761392 | Ospomyv | denosumab-dssb | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OSPOMYV | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
| 002 | XBRYK | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 70MG/ML | No | No |
| 003 | DENOSUMAB-DSSB | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
| 004 | DENOSUMAB-DSSB | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|
| OSPOMYV | DENOSUMAB | Cordavis Limited | e1d80a82-de52-4a34-9df3-609e50667ffb | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | BLA761392 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.