| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RELEUKO | 761082 | 001 | BLA | FILGRASTIM-AYOW | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 300MCG/ML/VIAL | No | No | 2022/02/25 | -- | KASHIV BIOSCIENCES LLC | Prescription |
| RELEUKO | 761082 | 002 | BLA | FILGRASTIM-AYOW | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 480MCG/1.6ML/VIAL | No | No | 2022/02/25 | -- | KASHIV BIOSCIENCES LLC | Prescription |
| RELEUKO | 761082 | 003 | BLA | FILGRASTIM-AYOW | SOLUTION;SUBCUTANEOUS | 300MCG/0.5ML | No | No | 2022/02/25 | -- | KASHIV BIOSCIENCES LLC | Prescription |
| RELEUKO | 761082 | 004 | BLA | FILGRASTIM-AYOW | SOLUTION;SUBCUTANEOUS | 480MCG/0.8ML | No | No | 2022/02/25 | -- | KASHIV BIOSCIENCES LLC | Prescription |