药品注册申请号:090704
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS 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 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 16MG;12.5MG No No AB 2012/12/04 2012/12/04 Prescription
002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;12.5MG No No AB 2012/12/04 Prescription
003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;25MG No No AB 2012/12/04 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2015/08/19 SUPPL 4 Approval Labeling STANDARD
2015/08/19 SUPPL 2 Approval Labeling STANDARD
2012/12/04 ORIG 1 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:CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:16MG;12.5MG 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
021093 001 NDA ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 16MG;12.5MG Prescription Yes No AB 2000/09/05 ANI PHARMS INC
090704 001 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 16MG;12.5MG Prescription No No AB 2012/12/04 MYLAN
202965 001 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 16MG;12.5MG Prescription No No AB 2013/06/03 DR REDDYS LABS LTD
204100 001 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 16MG;12.5MG Prescription No No AB 2015/02/27 MACLEODS PHARMS LTD
203466 001 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 16MG;12.5MG Prescription No No AB 2017/11/27 ZYDUS PHARMS
207455 001 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 16MG;12.5MG Prescription No No AB 2018/04/11 PRINSTON INC
活性成分:CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:32MG;12.5MG 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
021093 002 NDA ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;12.5MG Prescription Yes No AB 2000/09/05 ANI PHARMS INC
090704 002 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;12.5MG Prescription No No AB 2012/12/04 MYLAN
202965 002 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;12.5MG Prescription No No AB 2013/06/03 DR REDDYS LABS LTD
204100 002 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;12.5MG Prescription No No AB 2015/02/27 MACLEODS PHARMS LTD
203466 002 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;12.5MG Prescription No No AB 2017/11/27 ZYDUS PHARMS
207455 002 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;12.5MG Prescription No No AB 2018/04/11 PRINSTON INC
活性成分:CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:32MG;25MG 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
021093 003 NDA ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;25MG Prescription Yes Yes AB 2008/05/16 ANI PHARMS INC
090704 003 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;25MG Prescription No No AB 2012/12/04 MYLAN
202965 003 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;25MG Prescription No No AB 2013/06/03 DR REDDYS LABS LTD
204100 003 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;25MG Prescription No No AB 2015/02/27 MACLEODS PHARMS LTD
203466 003 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;25MG Prescription No No AB 2017/11/27 ZYDUS PHARMS
207455 003 ANDA CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 32MG;25MG Prescription No No AB 2018/04/11 PRINSTON INC
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