| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | 214529 | 002 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1GM/VIAL | No | No | 2023/07/17 | 2023/07/17 | SAGENT PHARMS INC | Prescription |
| CYCLOPHOSPHAMIDE | 214529 | 003 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL | No | No | 2023/07/17 | 2023/07/17 | SAGENT PHARMS INC | Prescription |
| CYCLOPHOSPHAMIDE | 217150 | 001 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/5ML (100MG/ML) | Yes | Yes | 2023/09/12 | 2023/09/12 | SANDOZ | Prescription |
| CYCLOPHOSPHAMIDE | 217150 | 002 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | Yes | Yes | 2023/09/12 | 2023/09/12 | SANDOZ | Prescription |
| CYCLOPHOSPHAMIDE | 217150 | 003 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/20ML (100MG/ML) | Yes | Yes | 2023/09/12 | 2023/09/12 | SANDOZ | Prescription |
| CYCLOPHOSPHAMIDE | 215089 | 001 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No | 2023/10/26 | 2023/10/26 | SUNNY | Prescription |
| CYCLOPHOSPHAMIDE | 215089 | 002 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1GM/VIAL | No | No | 2023/10/26 | 2023/10/26 | SUNNY | Prescription |
| CYCLOPHOSPHAMIDE | 215089 | 003 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL | No | No | 2023/10/26 | 2023/10/26 | SUNNY | Prescription |
| CYCLOPHOSPHAMIDE | 211552 | 001 | ANDA | CYCLOPHOSPHAMIDE | CAPSULE;ORAL | 25MG | No | No | 2023/12/13 | 2023/12/13 | ZYDUS LIFESCIENCES | Prescription |
| CYCLOPHOSPHAMIDE | 211552 | 002 | ANDA | CYCLOPHOSPHAMIDE | CAPSULE;ORAL | 50MG | No | No | 2023/12/13 | 2023/12/13 | ZYDUS LIFESCIENCES | Prescription |
| CYCLOPHOSPHAMIDE | 216958 | 001 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No | 2023/12/18 | 2023/12/18 | HIKMA | Prescription |
| CYCLOPHOSPHAMIDE | 216958 | 002 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1GM/VIAL | No | No | 2023/12/18 | 2023/12/18 | HIKMA | Prescription |
| CYCLOPHOSPHAMIDE | 216958 | 003 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL | No | No | 2023/12/18 | 2023/12/18 | HIKMA | Prescription |