药品注册申请号：020186
申请类型：NDA (新药申请)
申请人：TEVA BRANDED PHARM
申请人全名：TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC
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 ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Yes No AB 1993/03/26 1993/03/26 Prescription
002 ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Yes Yes AB 1993/03/26 Prescription
003 ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Yes No AB 1993/03/26 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1993/03/26 ORIG-1（原始申请） Approval Type 4 - New Combination STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/12/22 SUPPL-42（补充） Approval Labeling-Package Insert STANDARD
2021/03/02 SUPPL-37（补充） Approval Labeling-Package Insert STANDARD
2020/08/20 SUPPL-35（补充） Approval Labeling-Package Insert STANDARD
2015/07/27 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
2014/06/12 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2013/12/12 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
2011/05/03 SUPPL-28（补充） Approval Labeling-Package Insert UNKNOWN
2011/05/03 SUPPL-27（补充） Approval Labeling-Package Insert UNKNOWN
2009/11/06 SUPPL-26（补充） Approval Labeling-Package Insert UNKNOWN
2007/09/25 SUPPL-23（补充） Approval Labeling STANDARD
2003/01/24 SUPPL-15（补充） Approval Labeling STANDARD
2000/04/04 SUPPL-11（补充） Approval Labeling STANDARD
1999/06/22 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/02/16 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1998/04/01 SUPPL-8（补充） Approval Labeling STANDARD
1998/01/15 SUPPL-7（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1996/10/09 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/04/24 SUPPL-5（补充） Approval Labeling STANDARD
1995/05/30 SUPPL-4（补充） Approval Labeling STANDARD
1994/04/15 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/11/24 SUPPL-2（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/09/07 SUPPL-1（补充） Approval Manufacturing (CMC)-Expiration Date 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: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 EPIC PHARMA LLC
075768 002 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription No No AB 2000/09/25 MYLAN
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
215562 002 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription No No AB 2021/11/04 NOVITIUM PHARMA
215995 002 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription No No AB 2022/01/26 GLENMARK PHARMS LTD
215666 002 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG Prescription No No AB 2022/11/04 CADILA
>>>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 EPIC PHARMA LLC
075768 003 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription No No AB 2000/09/25 MYLAN
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
215562 003 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription No No AB 2021/11/04 NOVITIUM PHARMA
215995 003 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription No No AB 2022/01/26 GLENMARK PHARMS LTD
215666 003 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;6.25MG Prescription No No AB 2022/11/04 CADILA
>>>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 EPIC PHARMA LLC
075768 001 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription No No AB 2000/09/25 MYLAN
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
215562 001 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription No No AB 2021/11/04 NOVITIUM PHARMA
215995 001 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription No No AB 2022/01/26 GLENMARK PHARMS LTD
215666 001 ANDA BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 2.5MG;6.25MG Prescription No No AB 2022/11/04 CADILA
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