药品注册申请号：200797
申请类型：ANDA (仿制药申请)
申请人：LUPIN LTD
申请人全名：LUPIN 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, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;12.5MG;160MG No No AB 2015/06/03 2015/06/03 Prescription
002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;25MG;160MG No No AB 2015/06/03 Prescription
003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;12.5MG;160MG No No AB 2015/06/03 Prescription
004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;160MG No No AB 2015/06/03 Prescription
005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;320MG No No AB 2015/06/03 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
2020/03/16 SUPPL-4（补充） Approval Labeling STANDARD
2015/12/21 SUPPL-1（补充） Approval Labeling STANDARD
2015/06/03 ORIG-1（原始申请） Approval Not Applicable
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; HYDROCHLOROTHIAZIDE; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;12.5MG;160MG 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
022314 001 NDA EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;12.5MG;160MG Prescription Yes No AB 2009/04/30 NOVARTIS
201087 001 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;12.5MG;160MG Prescription No No AB 2015/06/01 STRIDES PHARMA
200797 001 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;12.5MG;160MG Prescription No No AB 2015/06/03 LUPIN LTD
206180 001 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;12.5MG;160MG Prescription No No AB 2017/12/19 AUROBINDO PHARMA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;25MG;160MG 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
022314 002 NDA EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;25MG;160MG Prescription Yes No AB 2009/04/30 NOVARTIS
201087 002 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;25MG;160MG Prescription No No AB 2015/06/01 STRIDES PHARMA
200797 002 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;25MG;160MG Prescription No No AB 2015/06/03 LUPIN LTD
206180 002 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;25MG;160MG Prescription No No AB 2017/12/19 AUROBINDO PHARMA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;12.5MG;160MG 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
022314 003 NDA EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;12.5MG;160MG Prescription Yes No AB 2009/04/30 NOVARTIS
201087 003 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;12.5MG;160MG Prescription No No AB 2015/06/01 STRIDES PHARMA
200797 003 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;12.5MG;160MG Prescription No No AB 2015/06/03 LUPIN LTD
206180 003 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;12.5MG;160MG Prescription No No AB 2017/12/19 AUROBINDO PHARMA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;25MG;160MG 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
022314 004 NDA EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;160MG Prescription Yes No AB 2009/04/30 NOVARTIS
201087 004 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;160MG Prescription No No AB 2015/06/01 STRIDES PHARMA
200797 004 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;160MG Prescription No No AB 2015/06/03 LUPIN LTD
206180 004 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;160MG Prescription No No AB 2017/12/19 AUROBINDO PHARMA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;25MG;320MG 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
022314 005 NDA EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;320MG Prescription Yes Yes AB 2009/04/30 NOVARTIS
201087 005 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;320MG Prescription No No AB 2015/06/01 STRIDES PHARMA
200797 005 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;320MG Prescription No No AB 2015/06/03 LUPIN LTD
206180 005 ANDA AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;320MG Prescription No No AB 2017/12/19 AUROBINDO PHARMA
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药品NDC数据与药品包装、标签说明书
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