药品注册申请号:075579
申请类型:ANDA (仿制药申请)
申请人:SANDOZ
申请人全名:SANDOZ 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 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG No No AB 2000/09/25 2000/09/25 Prescription
002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG No No AB 2000/09/25 Prescription
003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG No No AB 2000/09/25 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
2011/07/15 SUPPL 16 Approval Labeling
2009/03/31 SUPPL 14 Approval Labeling
2008/05/06 SUPPL 13 Approval Labeling
2002/10/30 SUPPL 3 Approval Manufacturing (CMC)
2002/10/30 SUPPL 2 Approval Manufacturing (CMC)
2002/10/30 SUPPL 1 Approval Manufacturing (CMC)
2000/09/25 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:BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:2.5MG;6.25MG 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
020186 003 NDA ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription Yes No AB 1993/03/26 TEVA BRANDED PHARM
075579 001 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription No No AB 2000/09/25 SANDOZ
079106 001 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription No No AB 2010/07/28 UNICHEM
212678 001 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription No No AB 2020/07/09 EDENBRIDGE PHARMS
活性成分:BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:5MG;6.25MG 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
020186 001 NDA ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription Yes No AB 1993/03/26 TEVA BRANDED PHARM
075579 002 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription No No AB 2000/09/25 SANDOZ
079106 002 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription No No AB 2010/07/28 UNICHEM
212678 002 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription No No AB 2020/07/09 EDENBRIDGE PHARMS
活性成分:BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:10MG;6.25MG 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
020186 002 NDA ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription Yes Yes AB 1993/03/26 TEVA BRANDED PHARM
075579 003 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription No No AB 2000/09/25 SANDOZ
079106 003 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription No No AB 2010/07/28 UNICHEM
212678 003 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription No No AB 2020/07/09 EDENBRIDGE PHARMS
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