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Application 761362
- Type
- BLA
- Sponsor
- SANDOZ INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | JUBBONTI | DENOSUMAB-BBDZ | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
| 002 | WYOST | DENOSUMAB-BBDZ | INJECTABLE;SUBCUTANEOUS | 120MG/1.7ML (70MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84019 | SUPPL | 2025-10-31 |
| 84018 | SUPPL | 2025-10-31 |
| 84002 | SUPPL | 2025-10-31 |
| 80016 | SUPPL | 2024-10-28 |
| 79987 | SUPPL | 2024-10-25 |
| 78914 | ORIG | 2024-06-27 |
| 77709 | ORIG | 2024-03-05 |
| 77708 | ORIG | 2024-03-05 |