药品注册申请号：200678
申请类型：NDA (新药申请)
申请人：ASTRAZENECA AB
申请人全名：ASTRAZENECA AB
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 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2010/11/05 2010/11/05 Discontinued
002 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2010/11/05 Discontinued
003 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2010/11/05 Discontinued
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
2010/11/05 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
2024/10/11 SUPPL-28（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2019/07/01 SUPPL-24（补充） Approval Labeling-Package Insert 901 REQUIRED
2017/02/27 SUPPL-18（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2017/01/18 SUPPL-20（补充） Approval Labeling-Package Insert STANDARD
2017/01/18 SUPPL-19（补充） Approval Labeling-Package Insert 901 REQUIRED
2016/04/05 SUPPL-13（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2015/08/28 SUPPL-16（补充） Approval Labeling-Package Insert 901 REQUIRED
2015/02/09 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
2013/05/24 SUPPL-10（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2013/05/15 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2012/11/08 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
2012/04/01 SUPPL-7（补充） Approval Labeling-Container/Carton Labels UNKNOWN
2012/03/07 SUPPL-4（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2012/03/07 SUPPL-3（补充） Approval Efficacy-New Indication STANDARD
2011/11/15 SUPPL-5（补充） Approval Labeling-Package Insert UNKNOWN
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
001 8628799 2025/07/13 Y 2014/01/31 PDF格式
9339472 2025/07/13 Y 2016/05/26 PDF格式
002 8628799 2025/07/13 Y 2017/03/22 PDF格式
9339472 2025/07/13 Y 2017/03/22 PDF格式
003 8628799 2025/07/13 Y 2017/03/22 PDF格式
9339472 2025/07/13 Y 2017/03/22 PDF格式
001 RE44186 2023/07/31 Y Y U-1838 U-1097 PDF格式**本条是由Drugfuture回溯的历史信息**
002 RE44186 2023/07/31 Y Y U-1838 U-1097 PDF格式**本条是由Drugfuture回溯的历史信息**
003 RE44186 2023/07/31 Y Y U-1097 U-1838 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 M-134 2016/05/24**本条是由Drugfuture回溯的历史信息**
M-175 2019/04/05**本条是由Drugfuture回溯的历史信息**
M-198 2020/02/27**本条是由Drugfuture回溯的历史信息**
NCE 2014/07/31**本条是由Drugfuture回溯的历史信息**
002 M-134 2016/05/24**本条是由Drugfuture回溯的历史信息**
M-175 2019/04/05**本条是由Drugfuture回溯的历史信息**
M-198 2020/02/27**本条是由Drugfuture回溯的历史信息**
NCE 2014/07/31**本条是由Drugfuture回溯的历史信息**
003 M-134 2016/05/24**本条是由Drugfuture回溯的历史信息**
M-175 2019/04/05**本条是由Drugfuture回溯的历史信息**
M-198 2020/02/27**本条是由Drugfuture回溯的历史信息**
NCE 2014/07/31**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
200678 001 NDA KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2010/11/05 ASTRAZENECA AB
>>>活性成分:METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
200678 002 NDA KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2010/11/05 ASTRAZENECA AB
>>>活性成分:METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
200678 003 NDA KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2010/11/05 ASTRAZENECA AB
更多信息
药品NDC数据与药品包装、标签说明书
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