| 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 | 210046 | 003 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL | No | No | 2018/05/25 | 2018/05/25 | AMNEAL | Prescription |
| CYCLOPHOSPHAMIDE | 211608 | 001 | ANDA | CYCLOPHOSPHAMIDE | CAPSULE;ORAL | 25MG | No | No | 2019/01/18 | 2019/01/18 | CIPLA | Prescription |
| CYCLOPHOSPHAMIDE | 211608 | 002 | ANDA | CYCLOPHOSPHAMIDE | CAPSULE;ORAL | 50MG | No | No | 2019/01/18 | 2019/01/18 | CIPLA | Prescription |
| CYCLOPHOSPHAMIDE | 212501 | 001 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/2.5ML (200MG/ML) | Yes | Yes | 2020/07/30 | 2020/07/30 | INGENUS PHARMS LLC | Prescription |
| CYCLOPHOSPHAMIDE | 212501 | 002 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/5ML (200MG/ML) | Yes | Yes | 2020/07/30 | 2020/07/30 | INGENUS PHARMS LLC | Prescription |
| CYCLOPHOSPHAMIDE | 212501 | 003 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/10ML (200MG/ML) | Yes | Yes | 2020/07/30 | 2021/11/19 | INGENUS PHARMS LLC | Prescription |
| CYCLOPHOSPHAMIDE | 210735 | 001 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/2.5ML (200MG/ML) | Yes | Yes | 2021/08/25 | 2021/08/25 | EUGIA PHARMA SPECLTS | Prescription |
| CYCLOPHOSPHAMIDE | 210735 | 002 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/5ML (200MG/ML) | Yes | Yes | 2021/08/25 | 2021/08/25 | EUGIA PHARMA SPECLTS | Prescription |
| CYCLOPHOSPHAMIDE | 210735 | 003 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/10ML (200MG/ML) | Yes | Yes | 2021/08/25 | 2023/11/20 | EUGIA PHARMA SPECLTS | Prescription |
| CYCLOPHOSPHAMIDE | 211757 | 001 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No | 2022/10/18 | 2022/10/18 | XGEN PHARMS | Prescription |
| CYCLOPHOSPHAMIDE | 211757 | 002 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1GM/VIAL | No | No | 2022/10/18 | 2022/10/18 | XGEN PHARMS | Prescription |
| CYCLOPHOSPHAMIDE | 211757 | 003 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL | No | No | 2022/10/18 | 2022/10/18 | XGEN PHARMS | Prescription |
| CYCLOPHOSPHAMIDE | 215892 | 001 | ANDA | CYCLOPHOSPHAMIDE | CAPSULE;ORAL | 25MG | No | No | 2022/11/10 | 2022/11/10 | ALEMBIC | Prescription |
| CYCLOPHOSPHAMIDE | 215892 | 002 | ANDA | CYCLOPHOSPHAMIDE | CAPSULE;ORAL | 50MG | No | No | 2022/11/10 | 2022/11/10 | ALEMBIC | Prescription |
| CYCLOPHOSPHAMIDE | 210852 | 001 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/ML (500MG/ML) | Yes | Yes | 2023/06/07 | 2023/06/07 | DR REDDYS | Prescription |
| CYCLOPHOSPHAMIDE | 210852 | 002 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/2ML (500MG/ML) | Yes | Yes | 2023/06/07 | 2023/06/07 | DR REDDYS | Prescription |
| CYCLOPHOSPHAMIDE | 210852 | 003 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/4ML (500MG/ML) | Yes | Yes | 2023/06/07 | 2023/06/07 | DR REDDYS | Prescription |
| CYCLOPHOSPHAMIDE | 217651 | 001 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/2.5ML (200MG/ML) | Yes | No | 2023/06/27 | 2023/06/28 | BAXTER HLTHCARE CORP | Discontinued |
| CYCLOPHOSPHAMIDE | 217651 | 002 | NDA | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/5ML (200MG/ML) | Yes | No | 2023/06/27 | 2023/06/28 | BAXTER HLTHCARE CORP | Discontinued |
| CYCLOPHOSPHAMIDE | 214529 | 001 | ANDA | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No | 2023/07/17 | 2023/07/17 | SAGENT PHARMS INC | Prescription |