Application 761400
- Type
- BLA
- Sponsor
- RENGENERON PHARMACEUTICALS, INC.
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761400 | Lynozyfic | linvoseltamab-gcpt | 351(a) | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LYNOZYFIC | LINVOSELTAMAB-GCPT | SOLUTION; INJECTION | 5MG/2ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82944 | ORIG | 2025-07-28 |
| 82759 | ORIG | 2025-07-09 |
| 82758 | ORIG | 2025-07-08 |
| 82726 | ORIG | 2025-07-02 |