药品注册申请号:217134
申请类型:ANDA (仿制药申请)
申请人:HAINAN POLY
申请人全名:HAINAN POLY PHARM CO LTD
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 IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 41% No No AP2 2023/09/27 2023/09/27 Prescription
002 IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 51% No No AP 2024/04/09 Prescription
003 IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 61% No No AP 2024/04/09 Prescription
004 IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 76% No No AP 2024/04/09 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
2024/04/09 SUPPL-1(补充) Approval Manufacturing (CMC) UNKNOWN
2023/09/27 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
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
与本品治疗等效的药品
活性成分:IOPAMIDOL 剂型/给药途径:INJECTABLE;INJECTION 规格:41% 治疗等效代码:AP2
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
018735 006 NDA ISOVUE-200 IOPAMIDOL INJECTABLE;INJECTION 41% Prescription Yes Yes AP2 1987/07/07 BRACCO
217134 001 ANDA IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 41% Prescription No No AP2 2023/09/27 HAINAN POLY
活性成分:IOPAMIDOL 剂型/给药途径:INJECTABLE;INJECTION 规格:51% 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
018735 007 NDA ISOVUE-250 IOPAMIDOL INJECTABLE;INJECTION 51% Prescription Yes Yes AP 1992/07/06 BRACCO
217134 002 ANDA IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 51% Prescription No No AP 2024/04/09 HAINAN POLY
活性成分:IOPAMIDOL 剂型/给药途径:INJECTABLE;INJECTION 规格:61% 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
018735 002 NDA ISOVUE-300 IOPAMIDOL INJECTABLE;INJECTION 61% Prescription Yes Yes AP 1985/12/31 BRACCO
018735 004 NDA ISOVUE-M 300 IOPAMIDOL INJECTABLE;INJECTION 61% Prescription Yes Yes AP 1985/12/31 BRACCO
215382 002 ANDA IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 61% Prescription No No AP 2023/02/27 HAINAN POLY
217134 003 ANDA IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 61% Prescription No No AP 2024/04/09 HAINAN POLY
活性成分:IOPAMIDOL 剂型/给药途径:INJECTABLE;INJECTION 规格:76% 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
018735 003 NDA ISOVUE-370 IOPAMIDOL INJECTABLE;INJECTION 76% Prescription Yes Yes AP 1985/12/31 BRACCO
217134 004 ANDA IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 76% Prescription No No AP 2024/04/09 HAINAN POLY
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