| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ISOSULFAN BLUE | 090874 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | Yes | 2010/07/20 | 2010/07/20 | MYLAN INSTITUTIONAL | Prescription |
| ISOSULFAN BLUE | 206831 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | No | 2016/02/02 | 2016/02/02 | EUGIA PHARMA | Discontinued |
| ISOSULFAN BLUE | 210714 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | No | 2019/01/16 | 2019/01/16 | BELOTECA | Discontinued |
| ISOSULFAN BLUE | 210558 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | No | 2019/07/12 | 2019/07/12 | SOMERSET THERAPS LLC | Discontinued |
| ISOSULFAN BLUE | 213130 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | No | 2021/11/03 | 2021/11/03 | MEITHEAL | Prescription |
| ISOSULFAN BLUE | 211869 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | No | 2022/09/08 | 2022/09/08 | FRESENIUS KABI USA | Discontinued |
| ISOSULFAN BLUE | 216090 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | No | 2022/09/16 | 2022/09/16 | MSN | Prescription |
| ISOSULFAN BLUE | 210294 | 001 | ANDA | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 50MG/5ML (10MG/ML) | No | No | 2023/05/17 | 2023/05/17 | AM REGENT | Prescription |