Application 761350
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPUVIZ | AFLIBERCEPT-YSZY | INJECTABLE;INJECTION | 2MG(0.05ML,40MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85503 | SUPPL | 2026-03-24 |
| 85457 | SUPPL | 2026-03-23 |
| 83208 | SUPPL | 2025-08-27 |
| 83201 | SUPPL | 2025-08-26 |
| 82508 | SUPPL | 2025-06-09 |
| 82483 | SUPPL | 2025-06-09 |
| 79820 | ORIG | 2024-10-07 |
| 78521 | ORIG | 2024-05-20 |
| 78513 | ORIG | 2024-05-20 |