Application 761346
- Type
- BLA
- Sponsor
- ACCORD BIOPHARMA INC.
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761346 | Hercessi | trastuzumab-strf | 351(k) Biosimilar | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HERCESSI | TRASTUZUMAB-STRF | INJECTABLE;INJECTION | 150MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79568 | SUPPL | 2024-09-09 |
| 79346 | ORIG | 2024-08-09 |
| 78257 | ORIG | 2024-04-25 |
| 78254 | ORIG | 2024-04-25 |