Application 761450
- Type
- BLA
- Sponsor
- SHANGHAI HENLIUS BIOTECH
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761450 | Poherdy | pertuzumab-dpzb | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POHERDY | PERTUZUMAB-DPZB | INJECTABLE;INTRAVENOUS | 420MG/14ML(30MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84170 | ORIG | 2025-11-17 |
| 84166 | ORIG | 2025-11-13 |