Application 761202
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BYOOVIZ | RANIBIZUMAB-NUNA | INJECTABLE;INJECTION | 0.5MG(10MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64406-019 | Byooviz | ranibizumab-nuna | BIOGEN INC. | BLA | Current |
| 64406-019 | Byooviz | ranibizumab | BIOGEN INC. | BLA | Current |
| 64406-019 | Byooviz | ranibizumab-nuna | BIOGEN INC. | BLA | Current |