药品注册申请号：077739
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA
申请人全名：AUROBINDO PHARMA LTD
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 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG No No AB 2007/09/11 2007/09/11 Prescription
002 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG No No AB 2007/09/11 Prescription
003 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG No No AB 2007/09/11 Prescription
004 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 37.5MG No No AB 2023/12/07 Prescription
005 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 75MG No No AB 2023/12/07 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
2023/11/22 SUPPL-30（补充） Approval Labeling STANDARD
2015/09/08 SUPPL-13（补充） Approval Labeling STANDARD
2014/07/19 SUPPL-8（补充） Approval Manufacturing (CMC)
2013/03/18 SUPPL-11（补充） Approval Labeling STANDARD
2013/03/18 SUPPL-9（补充） Approval Labeling
2010/03/12 SUPPL-7（补充） Approval Labeling
2009/02/26 SUPPL-5（补充） Approval Labeling
2008/09/15 SUPPL-3（补充） Approval Labeling
2008/09/15 SUPPL-2（补充） Approval Labeling
2007/09/11 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
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:METOPROLOL TARTRATE 剂型/给药途径:TABLET;ORAL 规格: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
076670 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Prescription No No AB 2004/01/15 SUN PHARM INDS INC
076704 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Prescription No No AB 2004/01/16 MYLAN
077739 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Prescription No No AB 2007/09/11 AUROBINDO PHARMA
078459 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Prescription No No AB 2008/06/17 IPCA LABS LTD
202871 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Prescription No No AB 2013/05/28 ALEMBIC PHARMS LTD
200981 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Prescription No No AB 2014/10/28 RUBICON
208955 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Prescription No No AB 2020/02/05 YOUNGTECH PHARMS INC
212402 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG Discontinued No No AB 2023/04/19 ZYDUS PHARMS
活性成分:METOPROLOL TARTRATE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
017963 001 NDA LOPRESSOR METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
074453 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 1995/04/27 RENATA
074644 001 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 1996/12/10 SUN PHARM INDS INC
076704 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 2004/01/16 MYLAN
077739 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 2007/09/11 AUROBINDO PHARMA
078459 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 2008/06/17 IPCA LABS LTD
202871 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 2013/05/28 ALEMBIC PHARMS LTD
200981 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 2014/10/28 RUBICON
208955 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Prescription No No AB 2020/02/05 YOUNGTECH PHARMS INC
212402 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG Discontinued No No AB 2023/04/19 ZYDUS PHARMS
活性成分:METOPROLOL TARTRATE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
017963 002 NDA LOPRESSOR METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
074453 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No No AB 1995/04/27 RENATA
074644 002 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No No AB 1996/12/10 SUN PHARM INDS INC
076704 003 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No Yes AB 2004/01/16 MYLAN
077739 003 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No No AB 2007/09/11 AUROBINDO PHARMA
078459 003 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No No AB 2008/06/17 IPCA LABS LTD
202871 003 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No No AB 2013/05/28 ALEMBIC PHARMS LTD
200981 003 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No No AB 2014/10/28 RUBICON
208955 003 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Prescription No No AB 2020/02/05 YOUNGTECH PHARMS INC
212402 003 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG Discontinued No No AB 2023/04/19 ZYDUS PHARMS
活性成分:METOPROLOL TARTRATE 剂型/给药途径:TABLET;ORAL 规格:37.5MG 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
076704 004 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 37.5MG Prescription No No AB 2015/03/18 MYLAN
200981 004 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 37.5MG Prescription No No AB 2019/08/21 RUBICON
077739 004 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 37.5MG Prescription No No AB 2023/12/07 AUROBINDO PHARMA
活性成分:METOPROLOL TARTRATE 剂型/给药途径:TABLET;ORAL 规格:75MG 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
076704 005 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 75MG Prescription No No AB 2015/03/18 MYLAN
200981 005 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 75MG Prescription No No AB 2019/08/21 RUBICON
077739 005 ANDA METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 75MG Prescription No No AB 2023/12/07 AUROBINDO PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database