药品注册申请号：078925
申请类型：ANDA (仿制药申请)
申请人：ALKEM
申请人全名：ALKEM LABORATORIES 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 AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE No No AB 2009/05/04 2009/05/04 Prescription
002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE No No AB 2009/05/04 Prescription
003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE No No AB 2009/05/04 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
2017/10/02 SUPPL-10（补充） Approval Labeling STANDARD
2015/11/24 SUPPL-7（补充） Approval Labeling STANDARD
2014/09/21 SUPPL-5（补充） Approval Labeling STANDARD
2013/07/09 SUPPL-2（补充） Approval Manufacturing (CMC)
2010/04/20 SUPPL-1（补充） Approval Labeling
2009/05/04 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:AMLODIPINE BESYLATE 剂型/给药途径:TABLET;ORAL 规格:EQ 2.5MG BASE 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
019787 001 NDA NORVASC AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription Yes No AB 1992/07/31 VIATRIS
076719 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/05/23 COREPHARMA
076846 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/06/28 TEVA
077974 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Discontinued No No AB 2007/07/09 SUN PHARM INDS LTD
078226 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/07/09 ZYDUS PHARMS USA
077516 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/07/11 STRIDES PHARMA
078043 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/07/12 LUPIN
078021 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/07/17 AUROBINDO PHARMA
076692 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/07/20 CHARTWELL RX
077955 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/08/28 INVAGEN PHARMS
077073 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2007/09/26 CIPLA
078552 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2009/04/08 EPIC PHARMA LLC
078925 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2009/05/04 ALKEM
078453 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2009/07/02 ORBION PHARMS
078414 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2010/04/07 OXFORD PHARMS
202553 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2013/04/29 ACCORD HLTHCARE
203245 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2013/10/21 UNICHEM
206367 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2015/12/10 INVAGEN PHARMS
090752 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2016/05/16 CHINA RESOURCES
207821 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2016/07/11 POLYGEN PHARMS
活性成分:AMLODIPINE BESYLATE 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE 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
019787 002 NDA NORVASC AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription Yes No AB 1992/07/31 VIATRIS
076719 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/05/23 COREPHARMA
076846 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/06/28 TEVA
077974 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2007/07/09 SUN PHARM INDS LTD
078226 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/07/09 ZYDUS PHARMS USA
077516 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/07/11 STRIDES PHARMA
078043 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/07/12 LUPIN
078021 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/07/17 AUROBINDO PHARMA
076692 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/07/20 CHARTWELL RX
077955 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/08/28 INVAGEN PHARMS
077073 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2007/09/26 CIPLA
078552 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2009/04/08 EPIC PHARMA LLC
078925 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2009/05/04 ALKEM
078453 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2009/07/02 ORBION PHARMS
078414 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2010/04/07 OXFORD PHARMS
090752 001 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2011/04/15 CHINA RESOURCES
202553 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2013/04/29 ACCORD HLTHCARE
203245 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2013/10/21 UNICHEM
206367 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2015/12/10 INVAGEN PHARMS
207821 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/07/11 POLYGEN PHARMS
活性成分:AMLODIPINE BESYLATE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 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
019787 003 NDA NORVASC AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription Yes Yes AB 1992/07/31 VIATRIS
076719 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/05/23 COREPHARMA
076846 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/06/28 TEVA
077974 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2007/07/09 SUN PHARM INDS LTD
078226 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/07/09 ZYDUS PHARMS USA
077516 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/07/11 STRIDES PHARMA
078043 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/07/12 LUPIN
078021 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/07/17 AUROBINDO PHARMA
076692 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/07/20 CHARTWELL RX
077955 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/08/28 INVAGEN PHARMS
077073 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/09/26 CIPLA
078552 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2009/04/08 EPIC PHARMA LLC
078925 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2009/05/04 ALKEM
078453 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2009/07/02 ORBION PHARMS
078414 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2010/04/07 OXFORD PHARMS
090752 002 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2011/04/15 CHINA RESOURCES
202553 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2013/04/29 ACCORD HLTHCARE
203245 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2013/10/21 UNICHEM
206367 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2015/12/10 INVAGEN PHARMS
207821 003 ANDA AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/07/11 POLYGEN PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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