Application 761404
- Type
- BLA
- Sponsor
- CELLTRION INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761404 | Stoboclo | denosumab-bmwo | 351(k) Interchangeable | Rx | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STOBOCLO | DENOSUMAB-BMWO | INJECTABLE;INJECTION | 60MG/ML | No | No |
| 002 | OSENVELT | DENOSUMAB-BMWO | INJECTABLE;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 |
|---|---|---|---|---|---|---|
| Denosumab-BMWO | DENOSUMAB-BMWO | CELLTRION USA, Inc. | 7a449553-105c-46a1-bb72-849d8f5b81bd | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | BLA761404 |
| Denosumab-BMWO | DENOSUMAB-BMWO | CELLTRION USA, Inc. | d378622d-3a13-4918-ae18-3375cd10d270 | 2026-02-05 | Warnings, Adverse reactions | BLA761404 |
| Stoboclo | DENOSUMAB-BMWO | CELLTRION USA, Inc. | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | BLA761404 |
| Osenvelt | DENOSUMAB-BMWO | CELLTRION USA, Inc. | c5a5d750-80be-49cd-b4a6-c8a815956059 | 2026-02-05 | Warnings, Adverse reactions | BLA761404 |