药品注册申请号：210016
申请类型：ANDA (仿制药申请)
申请人：GE HEALTHCARE
申请人全名：GE HEALTHCARE
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 3.769GM/10ML (376.9MG/ML) No No AP 2019/11/01 2019/11/01 Prescription
002 CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 5.6535GM/15ML (376.9MG/ML) No No AP 2019/11/01 Prescription
003 CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 7.538GM/20ML (376.9MG/ML) No No AP 2019/11/01 Prescription
004 CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 37.69GM/100ML (376.9MG/ML) No No AP 2020/08/04 Prescription
005 CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 1.8845GM/5ML (376.9MG/ML) No No AP 2020/11/24 Prescription
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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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
218073 002 ANDA GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 3.769GM/10ML (376.9MG/ML) Prescription No No AP 2024/06/17 HAINAN POLY
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RLDRSTE 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
218073 003 ANDA GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 5.6535GM/15ML (376.9MG/ML) Prescription No No AP 2024/06/17 HAINAN POLY
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RLDRSTE 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
218073 004 ANDA GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 7.538GM/20ML (376.9MG/ML) Prescription No No AP 2024/06/17 HAINAN POLY
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RLDRSTE 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
218073 005 ANDA GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 37.69GM/100ML (376.9MG/ML) Prescription No No AP 2024/06/17 HAINAN POLY
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RLDRSTE 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
218073 001 ANDA GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 1.8845GM/5ML (376.9MG/ML) Prescription No No AP 2024/06/17 HAINAN POLY
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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