Skip to contentApplication 761404
- Type
- BLA
- Sponsor
- CELLTRION INC
Application Products#
Product, Drug, Ingredient table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84059 | SUPPL | 2025-11-04 |
| 84054 | ORIG | 2025-11-04 |
| 83328 | SUPPL | 2025-11-03 |
| 84010 | ORIG | 2025-10-31 |
| 84007 | ORIG | 2025-10-31 |
| 83973 | ORIG | 2025-10-29 |
| 83361 | SUPPL | 2025-09-17 |
| 81505 | ORIG | 2025-03-10 |
| 81434 | ORIG | 2025-03-06 |
| 81384 | ORIG | 2025-02-28 |