药品注册申请号：077912
申请类型：ANDA (仿制药申请)
申请人：LUPIN
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 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG No No AB 2006/09/27 2006/09/27 Prescription
002 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG No No AB 2006/09/27 Prescription
003 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG No No AB 2006/09/27 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
2023/03/17 SUPPL-43（补充） Approval Labeling STANDARD
2023/03/17 SUPPL-35（补充） Approval Labeling STANDARD
2023/03/17 SUPPL-33（补充） Approval Labeling STANDARD
2023/03/17 SUPPL-28（补充） Approval Labeling STANDARD
2014/02/28 SUPPL-23（补充） Approval Labeling STANDARD
2014/02/28 SUPPL-20（补充） Approval Labeling STANDARD
2014/02/28 SUPPL-19（补充） Approval Labeling
2009/08/31 SUPPL-8（补充） Approval Labeling
2007/01/11 SUPPL-1（补充） Approval Labeling
2006/09/27 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:HYDROCHLOROTHIAZIDE; LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG;10MG 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
019888 003 NDA ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription Yes No AB 1993/11/18 ALMATICA
076007 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
076194 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2002/07/01 WATSON LABS
076230 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2002/07/01 PRINSTON INC
076262 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2002/07/01 SANDOZ
076674 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2004/10/05 COREPHARMA
077606 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2006/03/14 AUROBINDO
077912 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2006/09/27 LUPIN
204058 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Prescription No No AB 2017/05/23 INVAGEN PHARMS
活性成分:HYDROCHLOROTHIAZIDE; LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG;20MG 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
019888 001 NDA ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription Yes No AB 1990/09/20 ALMATICA
076007 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
076194 001 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2002/07/01 WATSON LABS
076230 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2002/07/01 PRINSTON INC
076262 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2002/07/01 SANDOZ
076674 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2004/10/05 COREPHARMA
077606 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2006/03/14 AUROBINDO
077912 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2006/09/27 LUPIN
204058 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Prescription No Yes AB 2017/05/23 INVAGEN PHARMS
活性成分:HYDROCHLOROTHIAZIDE; LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:25MG;20MG 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
019888 002 NDA ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription Yes No AB 1989/07/20 ALMATICA
076007 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
076194 002 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No No AB 2002/07/01 WATSON LABS
076230 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No No AB 2002/07/01 PRINSTON INC
076262 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No No AB 2002/07/01 SANDOZ
076674 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No No AB 2004/10/05 COREPHARMA
077606 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No No AB 2006/03/14 AUROBINDO
077912 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No No AB 2006/09/27 LUPIN
204058 003 ANDA LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Prescription No Yes AB 2017/05/23 INVAGEN PHARMS
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药品NDC数据与药品包装、标签说明书
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