Application 761436
- Type
- BLA
- Sponsor
- BIOCON BIOLOGICS INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761436 | Bosaya | denosumab-kyqq | 351(k) Interchangeable | Rx | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUKELSO | DENOSUMAB-KYQQ | INJECTABLE;INJECTION | 120MG/1.7ML(70MG/ML) | No | No |
| 002 | BOSAYA | DENOSUMAB-KYQQ | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|
| AUKELSO | DENOSUMAB-KYQQ | Biocon Biologics Inc. | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2026-03-27 | Warnings, Adverse reactions | BLA761436 |
| BOSAYA | DENOSUMAB-KYQQ | Biocon Biologics Inc. | 1e5e8c88-3c65-3076-e44b-02d92c2d343d | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | BLA761436 |