批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2023/11/29 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/11/24 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/01 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:3.769GM/10ML (376.9MG/ML) 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 204781 |
002 |
NDA |
DOTAREM |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
3.769GM/10ML (376.9MG/ML) |
Prescription |
Yes |
Yes |
AP |
2013/03/20
|
GUERBET |
| 210016 |
001 |
ANDA |
CLARISCAN |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
3.769GM/10ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2019/11/01
|
GE HEALTHCARE |
| 215304 |
002 |
ANDA |
GADOTERATE MEGLUMINE |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
3.769GM/10ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
HENGRUI PHARMA |
活性成分:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:5.6535GM/15ML (376.9MG/ML) 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 204781 |
003 |
NDA |
DOTAREM |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
5.6535GM/15ML (376.9MG/ML) |
Prescription |
Yes |
Yes |
AP |
2013/03/20
|
GUERBET |
| 210016 |
002 |
ANDA |
CLARISCAN |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
5.6535GM/15ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2019/11/01
|
GE HEALTHCARE |
| 215304 |
003 |
ANDA |
GADOTERATE MEGLUMINE |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
5.6535GM/15ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
HENGRUI PHARMA |
活性成分:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:7.538GM/20ML (376.9MG/ML) 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 204781 |
004 |
NDA |
DOTAREM |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
7.538GM/20ML (376.9MG/ML) |
Prescription |
Yes |
Yes |
AP |
2013/03/20
|
GUERBET |
| 210016 |
003 |
ANDA |
CLARISCAN |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
7.538GM/20ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2019/11/01
|
GE HEALTHCARE |
| 215304 |
004 |
ANDA |
GADOTERATE MEGLUMINE |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
7.538GM/20ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
HENGRUI PHARMA |
活性成分:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:37.69GM/100ML (376.9MG/ML) 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 204781 |
001 |
NDA |
DOTAREM |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
37.69GM/100ML (376.9MG/ML) |
Prescription |
Yes |
Yes |
AP |
2013/03/20
|
GUERBET |
| 210016 |
004 |
ANDA |
CLARISCAN |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
37.69GM/100ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2020/08/04
|
GE HEALTHCARE |
| 215304 |
005 |
ANDA |
GADOTERATE MEGLUMINE |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
37.69GM/100ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2022/04/15
|
HENGRUI PHARMA |
活性成分:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:1.8845GM/5ML (376.9MG/ML) 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 204781 |
005 |
NDA |
DOTAREM |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
1.8845GM/5ML (376.9MG/ML) |
Prescription |
Yes |
Yes |
AP |
2017/03/31
|
GUERBET |
| 210016 |
005 |
ANDA |
CLARISCAN |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
1.8845GM/5ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2020/11/24
|
GE HEALTHCARE |
| 215304 |
001 |
ANDA |
GADOTERATE MEGLUMINE |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
1.8845GM/5ML (376.9MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
HENGRUI PHARMA |
