Application 761436
- Type
- BLA
- Sponsor
- BIOCON BIOLOGICS INC
Application Products#
Product, Drug, Ingredient table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84349 | ORIG | 2025-12-08 |
| 84348 | ORIG | 2025-12-08 |
| 84021 | ORIG | 2025-10-31 |
| 84020 | ORIG | 2025-10-31 |
| 84011 | ORIG | 2025-10-31 |
| 83379 | ORIG | 2025-09-18 |
| 83372 | ORIG | 2025-09-17 |
| 83371 | ORIG | 2025-09-17 |