Application 761134
- Type
- BLA
- Sponsor
- EVIVE BIOTECHNOLOGY
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761134 | Ryzneuta | efbemalenograstim alfa-vuxw | 351(a) | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RYZNEUTA | EFBEMALENOGRASTIM ALFA-VUXW | INJECTABLE;INJECTION | 20MG/ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76753 | ORIG | 2023-12-08 |
| 76620 | ORIG | 2023-11-17 |
| 76606 | ORIG | 2023-11-17 |