药品注册申请号：202519
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA LTD
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 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG No No AB 2013/03/21 2013/03/21 Prescription
002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG No No AB 2013/03/21 Prescription
003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG No No AB 2013/03/21 Prescription
004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG No No AB 2013/03/21 Prescription
005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG No No AB 2013/03/21 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
2013/03/21 ORIG-1（原始申请） Approval
>>>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
2022/04/04 SUPPL-15（补充） Approval Labeling-Package Insert STANDARD
2019/08/16 SUPPL-12（补充） Approval Labeling-Package Insert STANDARD
2019/08/16 SUPPL-5（补充） Approval Labeling-Package Insert STANDARD
2015/01/16 SUPPL-4（补充） Approval Labeling-Package Insert STANDARD
2015/01/16 SUPPL-3（补充） Approval Labeling-Package Insert 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:HYDROCHLOROTHIAZIDE; VALSARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;80MG; 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
020818 001 NDA DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription Yes No AB 1998/03/06 NOVARTIS
078020 001 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2012/09/21 MYLAN PHARMS INC
078946 003 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2013/03/21 LUPIN LTD
201662 001 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2013/03/21 ALEMBIC
202519 001 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2013/03/21 AUROBINDO PHARMA LTD
203145 001 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2013/04/19 MACLEODS PHARMS LTD
206083 001 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2016/02/08 PRINSTON INC
204382 001 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2023/08/11 AMNEAL PHARMS
>>>活性成分:HYDROCHLOROTHIAZIDE; VALSARTAN; 剂型/给药途径:TABLET;ORAL; 规格: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
020818 002 NDA DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription Yes No AB 1998/03/06 NOVARTIS
078020 002 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription No No AB 2012/09/21 MYLAN PHARMS INC
078946 004 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription No No AB 2013/03/21 LUPIN LTD
201662 002 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription No No AB 2013/03/21 ALEMBIC
202519 002 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription No No AB 2013/03/21 AUROBINDO PHARMA LTD
203145 002 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription No No AB 2013/04/19 MACLEODS PHARMS LTD
206083 002 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription No No AB 2016/02/08 PRINSTON INC
204382 002 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;160MG Prescription No No AB 2023/08/11 AMNEAL PHARMS
>>>活性成分:HYDROCHLOROTHIAZIDE; VALSARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;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
020818 004 NDA DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription Yes No AB 2006/04/28 NOVARTIS
078020 004 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription No No AB 2012/09/21 MYLAN PHARMS INC
078946 001 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription No No AB 2013/03/21 LUPIN LTD
201662 003 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription No No AB 2013/03/21 ALEMBIC
202519 003 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription No No AB 2013/03/21 AUROBINDO PHARMA LTD
203145 003 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription No No AB 2013/04/19 MACLEODS PHARMS LTD
206083 003 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription No No AB 2016/02/08 PRINSTON INC
204382 004 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 12.5MG;320MG Prescription No No AB 2023/08/11 AMNEAL PHARMS
>>>活性成分:HYDROCHLOROTHIAZIDE; VALSARTAN; 剂型/给药途径:TABLET;ORAL; 规格: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
020818 003 NDA DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription Yes No AB 2002/01/17 NOVARTIS
078020 003 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription No No AB 2012/09/21 MYLAN PHARMS INC
078946 005 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription No No AB 2013/03/21 LUPIN LTD
201662 004 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription No No AB 2013/03/21 ALEMBIC
202519 004 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription No No AB 2013/03/21 AUROBINDO PHARMA LTD
203145 004 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription No No AB 2013/04/19 MACLEODS PHARMS LTD
206083 004 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription No No AB 2016/02/08 PRINSTON INC
204382 003 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;160MG Prescription No No AB 2023/08/11 AMNEAL PHARMS
>>>活性成分:HYDROCHLOROTHIAZIDE; VALSARTAN; 剂型/给药途径:TABLET;ORAL; 规格: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
020818 005 NDA DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription Yes Yes AB 2006/04/28 NOVARTIS
078020 005 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription No No AB 2012/09/21 MYLAN PHARMS INC
078946 002 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription No No AB 2013/03/21 LUPIN LTD
201662 005 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription No No AB 2013/03/21 ALEMBIC
202519 005 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription No No AB 2013/03/21 AUROBINDO PHARMA LTD
203145 005 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription No No AB 2013/04/19 MACLEODS PHARMS LTD
206083 005 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription No No AB 2016/02/08 PRINSTON INC
204382 005 ANDA VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL 25MG;320MG Prescription No No AB 2023/08/11 AMNEAL PHARMS
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