Application 761198
- Type
- BLA
- Sponsor
- BIO-THERA SOLUTIONS LTD
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761198 | Avzivi | bevacizumab-tnjn | 351(k) Biosimilar | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AVZIVI | BEVACIZUMAB-TNJN | INJECTABLE;INJECTION | 100MG/4ML(25MG/ML) | No | No |
| 002 | AVZIVI | BEVACIZUMAB-TNJN | INJECTABLE;INJECTION | 400MG/16ML(25MG/ML) | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78073 | ORIG | 2024-04-05 |
| 76750 | ORIG | 2023-12-07 |
| 76747 | ORIG | 2023-12-07 |