| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GADOTERATE MEGLUMINE | 215304 | 001 | ANDA | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 1.8845GM/5ML (376.9MG/ML) | No | No | 2022/04/11 | 2022/04/11 | HENGRUI PHARMA | Prescription |
| GADOTERATE MEGLUMINE | 215304 | 002 | ANDA | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 3.769GM/10ML (376.9MG/ML) | No | No | 2022/04/11 | 2022/04/11 | HENGRUI PHARMA | Prescription |
| GADOTERATE MEGLUMINE | 215304 | 003 | ANDA | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 5.6535GM/15ML (376.9MG/ML) | No | No | 2022/04/11 | 2022/04/11 | HENGRUI PHARMA | Prescription |
| GADOTERATE MEGLUMINE | 215304 | 004 | ANDA | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 7.538GM/20ML (376.9MG/ML) | No | No | 2022/04/11 | 2022/04/11 | HENGRUI PHARMA | Prescription |
| GADOTERATE MEGLUMINE | 215304 | 005 | ANDA | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 37.69GM/100ML (376.9MG/ML) | No | No | 2022/04/11 | 2022/04/15 | HENGRUI PHARMA | Prescription |