Application 761355
- Type
- BLA
- Sponsor
- REGENERON PHARMACEUTICALS
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761355 | Eylea HD | aflibercept | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EYLEA HD | AFLIBERCEPT | INJECTABLE;INJECTION | 8MG(0.07ML;114.3MG/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 |
|---|---|---|---|---|---|---|
| EYLEA HD | AFLIBERCEPT | Regeneron Pharmaceuticals, Inc | 86d8848b-111b-4da9-8957-7cccef1b8f66 | 2026-04-06 | Warnings, Adverse reactions | BLA761355 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.