Application 761473
- Type
- BLA
- Sponsor
- FORMYCON AG
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761473 | Nufymco | ranibizumab-leyk | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NUFYMCO | RANIBIZUMAB-LEYK | INJECTION | 6MG/ML | No | No |
| 002 | NUFYMCO | RANIBIZUMAB-LEYK | INJECTION | 10MG/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 |
|---|
| 84475 | ORIG | 2025-12-19 |