Application 761084
- Type
- BLA
- Sponsor
- KASHIV BIOSCIENCES LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FYLNETRA | PEGFILGRASTIM-PBBK | INJECTABLE;INJECTION | 6MG/0.6ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70121-1627 | FYLNETRA | pegfilgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1627 | FYLNETRA | pegfilgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1627 | FYLNETRA | pegfilgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82094 | SUPPL | 2025-05-01 |
| 81982 | SUPPL | 2025-04-24 |
| 71555 | ORIG | 2022-07-15 |
| 71231 | ORIG | 2022-06-07 |
| 71155 | ORIG | 2022-05-26 |