药品注册申请号：091370
申请类型：ANDA (仿制药申请)
申请人：ALEMBIC
申请人全名：ALEMBIC PHARMACEUTICALS 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 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No AB;AB 2012/10/15 2012/10/15 Prescription
002 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No AB;AB 2012/10/15 Prescription
003 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG No No AB;AB 2016/10/12 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
2016/10/12 ORIG-2（原始申请） Approval
2012/10/15 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
2023/08/25 SUPPL-30（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2023/08/25 SUPPL-28（补充） Approval Labeling-Package Insert STANDARD
2021/06/04 SUPPL-26（补充） Approval Labeling-Package Insert STANDARD
2021/06/04 SUPPL-23（补充） Approval Labeling-Package Insert STANDARD
2019/04/25 SUPPL-13（补充） Approval Labeling-Package Insert STANDARD
2019/04/25 SUPPL-8（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2013/08/29 SUPPL-1（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; IRBESARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;150MG; 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
020758 002 NDA AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription Yes Yes AB 1997/09/30 SANOFI AVENTIS US
077369 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/03/30 TEVA
077446 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 SANDOZ
202414 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 MACLEODS PHARMS LTD
203500 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 DR REDDYS LABS LTD
090351 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/10/15 HIKMA
091370 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/10/15 ALEMBIC
203630 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2013/02/22 AUROBINDO PHARMA LTD
201524 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Discontinued No No AB 2013/02/27 LUPIN LTD
203072 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2014/05/09 PRINSTON INC
207896 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2016/10/14 HISUN PHARM HANGZHOU
207018 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Discontinued No No AB 2017/09/19 UNICHEM
>>>活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;150MG; 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
020758 002 NDA AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription Yes Yes AB 1997/09/30 SANOFI AVENTIS US
077369 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/03/30 TEVA
077446 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 SANDOZ
202414 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 MACLEODS PHARMS LTD
203500 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 DR REDDYS LABS LTD
090351 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/10/15 HIKMA
091370 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/10/15 ALEMBIC
203630 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2013/02/22 AUROBINDO PHARMA LTD
201524 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Discontinued No No AB 2013/02/27 LUPIN LTD
203072 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2014/05/09 PRINSTON INC
207896 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2016/10/14 HISUN PHARM HANGZHOU
207018 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Discontinued No No AB 2017/09/19 UNICHEM
>>>活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;300MG; 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
020758 003 NDA AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription Yes Yes AB 1998/08/31 SANOFI AVENTIS US
077369 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/03/30 TEVA
077446 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 SANDOZ
202414 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 MACLEODS PHARMS LTD
203500 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 DR REDDYS LABS LTD
090351 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/10/15 HIKMA
091370 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/10/15 ALEMBIC
203630 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2013/02/22 AUROBINDO PHARMA LTD
201524 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Discontinued No No AB 2013/02/27 LUPIN LTD
203072 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2014/05/09 PRINSTON INC
207896 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2016/10/14 HISUN PHARM HANGZHOU
207018 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Discontinued No No AB 2017/09/19 UNICHEM
>>>活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;300MG; 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
020758 003 NDA AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription Yes Yes AB 1998/08/31 SANOFI AVENTIS US
077369 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/03/30 TEVA
077446 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 SANDOZ
202414 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 MACLEODS PHARMS LTD
203500 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 DR REDDYS LABS LTD
090351 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/10/15 HIKMA
091370 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/10/15 ALEMBIC
203630 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2013/02/22 AUROBINDO PHARMA LTD
201524 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Discontinued No No AB 2013/02/27 LUPIN LTD
203072 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2014/05/09 PRINSTON INC
207896 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2016/10/14 HISUN PHARM HANGZHOU
207018 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Discontinued No No AB 2017/09/19 UNICHEM
>>>活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN; 剂型/给药途径:TABLET;ORAL; 规格:25MG;300MG; 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
203630 003 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG Prescription No No AB 2016/03/31 AUROBINDO PHARMA LTD
091370 003 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG Prescription No No AB 2016/10/12 ALEMBIC
090351 003 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG Prescription No No AB 2017/06/08 HIKMA
>>>活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN; 剂型/给药途径:TABLET;ORAL; 规格:25MG;300MG; 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
203630 003 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG Prescription No No AB 2016/03/31 AUROBINDO PHARMA LTD
091370 003 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG Prescription No No AB 2016/10/12 ALEMBIC
090351 003 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG Prescription No No AB 2017/06/08 HIKMA
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