药品注册申请号:076943
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS USA INC
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 TORSEMIDE TORSEMIDE TABLET;ORAL 5MG No No AB 2005/03/01 2005/03/01 Prescription
002 TORSEMIDE TORSEMIDE TABLET;ORAL 10MG No No AB 2005/03/01 Prescription
003 TORSEMIDE TORSEMIDE TABLET;ORAL 20MG No No AB 2005/03/01 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
2023/07/21 SUPPL-4(补充) Approval Labeling STANDARD
2012/09/26 SUPPL-3(补充) Approval Labeling STANDARD
2005/03/01 ORIG-1(原始申请) Approval
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:TORSEMIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AB
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
076110 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Discontinued No No AB 2002/05/14 TEVA
076226 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Prescription No No AB 2003/05/27 STRIDES PHARMA
076346 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Prescription No No AB 2003/05/30 PLIVA PHARM IND
076943 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Prescription No No AB 2005/03/01 HIKMA
076894 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Prescription No No AB 2005/05/31 COREPHARMA
078249 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Prescription No No AB 2007/10/17 AUROBINDO PHARMA
079234 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Prescription No No AB 2009/01/27 HETERO LABS LTD III
090613 001 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 5MG Prescription No No AB 2011/03/22 STRIDES PHARMA
活性成分:TORSEMIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
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
076226 002 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 10MG Prescription No No AB 2003/05/27 STRIDES PHARMA
076346 002 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 10MG Prescription No No AB 2003/05/30 PLIVA PHARM IND
076943 002 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 10MG Prescription No No AB 2005/03/01 HIKMA
076894 002 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 10MG Prescription No No AB 2005/05/31 COREPHARMA
078249 002 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 10MG Prescription No No AB 2007/10/17 AUROBINDO PHARMA
079234 002 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 10MG Prescription No No AB 2009/01/27 HETERO LABS LTD III
090613 002 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 10MG Prescription No No AB 2011/03/22 STRIDES PHARMA
活性成分:TORSEMIDE 剂型/给药途径:TABLET;ORAL 规格:20MG 治疗等效代码:AB
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
076226 003 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 20MG Prescription No No AB 2003/05/27 STRIDES PHARMA
076346 003 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 20MG Prescription No Yes AB 2003/05/30 PLIVA PHARM IND
076943 003 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 20MG Prescription No No AB 2005/03/01 HIKMA
076894 003 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 20MG Prescription No No AB 2005/05/31 COREPHARMA
078249 003 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 20MG Prescription No No AB 2007/10/17 AUROBINDO PHARMA
079234 003 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 20MG Prescription No No AB 2009/01/27 HETERO LABS LTD III
090613 003 ANDA TORSEMIDE TORSEMIDE TABLET;ORAL 20MG Prescription No No AB 2011/03/22 STRIDES PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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