药品注册申请号：078212
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA
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 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2008/05/22 2008/05/22 Prescription
002 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG No No AB 2008/05/22 Prescription
003 BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG No Yes AB 2008/05/22 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
2019/04/02 SUPPL-17（补充） Approval Labeling STANDARD
2018/09/25 SUPPL-16（补充） Approval Labeling STANDARD
2015/11/12 SUPPL-15（补充） Approval Labeling STANDARD
2015/04/28 SUPPL-14（补充） Approval Labeling STANDARD
2015/04/28 SUPPL-13（补充） Approval Labeling STANDARD
2015/04/28 SUPPL-10（补充） Approval Labeling STANDARD
2012/11/08 SUPPL-9（补充） Approval Labeling STANDARD
2012/11/08 SUPPL-8（补充） Approval Labeling
2011/09/21 SUPPL-6（补充） Approval Labeling
2009/12/24 SUPPL-4（补充） Approval Labeling
2009/06/12 SUPPL-2（补充） Approval Labeling
2008/08/18 SUPPL-1（补充） Approval Labeling
2008/05/22 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:BENAZEPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格: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
019851 002 NDA LOTENSIN BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes No AB 1991/06/25 VALIDUS PHARMS
076118 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/02/11 PRINSTON INC
076211 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/02/11 TEVA
076267 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/02/11 HERITAGE PHARMA
076333 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/02/11 ANI PHARMS
076344 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/02/11 SUN PHARM INDS LTD
076402 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/02/11 CHARTWELL RX
076820 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2006/02/03 AMNEAL PHARMS
077128 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2006/03/08 COREPHARMA
078212 001 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/05/22 AUROBINDO PHARMA
078848 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/05/23 ZYDUS LIFESCIENCES
活性成分:BENAZEPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格: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
019851 003 NDA LOTENSIN BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription Yes No AB 1991/06/25 VALIDUS PHARMS
076118 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2004/02/11 PRINSTON INC
076211 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2004/02/11 TEVA
076267 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2004/02/11 HERITAGE PHARMA
076333 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2004/02/11 ANI PHARMS
076344 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2004/02/11 SUN PHARM INDS LTD
076402 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2004/02/11 CHARTWELL RX
076820 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2006/02/03 AMNEAL PHARMS
077128 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2006/03/08 COREPHARMA
078212 002 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2008/05/22 AUROBINDO PHARMA
078848 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2008/05/23 ZYDUS LIFESCIENCES
活性成分:BENAZEPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:40MG 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
019851 004 NDA LOTENSIN BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription Yes No AB 1991/06/25 VALIDUS PHARMS
076118 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2004/02/11 PRINSTON INC
076211 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2004/02/11 TEVA
076267 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2004/02/11 HERITAGE PHARMA
076333 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2004/02/11 ANI PHARMS
076344 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2004/02/11 SUN PHARM INDS LTD
076402 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2004/02/11 CHARTWELL RX
076820 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2006/02/03 AMNEAL PHARMS
077128 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2006/03/08 COREPHARMA
078212 003 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No Yes AB 2008/05/22 AUROBINDO PHARMA
078848 004 ANDA BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2008/05/23 ZYDUS LIFESCIENCES
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database