Application 761147
- 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 |
|---|
| 761147 | Ennumo | pegfilgrastim-pccg | 351(k) Biosimilar | Rx | 2026-07-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENNUMO | PEGFILGRASTIM-PCCG | INJECTABLE;SUBCUTANEOUS | 6MG/0.6ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85943 | ORIG | 2026-05-18 |
| 85879 | ORIG | 2026-05-12 |