Application 761268
- Type
- BLA
- Sponsor
- CELLTRION
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761268 | Vegzelma | bevacizumab-adcd | 351(k) Biosimilar | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VEGZELMA | BEVACIZUMAB-ADCD | INJECTABLE;INJECTION | 100MG/4ML(25MG/ML) | No | No |
| 002 | VEGZELMA | BEVACIZUMAB-ADCD | INJECTABLE;INJECTION | 400MG/16ML(25MG/ML) | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vegzelma | BEVACIZUMAB-ADCD | CELLTRION USA, Inc. | 4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe | 2026-08-21 | Warnings, Adverse reactions | BLA761268 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.