Application 761419
- Type
- BLA
- Sponsor
- BIO-THERA SOLUTIONS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | STARJEMZA | USTEKINUMAB-HMNY | INJECTABLE;SUBCUTANEOUS | 45MG/0.5ML | No | No |
| 002 | STARJEMZA | USTEKINUMAB-HMNY | INJECTABLE;SUBCUTANEOUS | 130MG/26ML | No | No |
| 003 | STARJEMZA | USTEKINUMAB-HMNY | INJECTABLE;SUBCUTANEOUS | 90MG/ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82406 | ORIG | 2025-06-02 |
| 82405 | ORIG | 2025-06-02 |
| 82319 | ORIG | 2025-05-27 |