药品注册申请号:020033
申请类型:NDA (新药申请)
申请人:VALIDUS PHARMS
申请人全名:VALIDUS PHARMACEUTICALS LLC
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 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1992/05/19 1992/05/19 Discontinued
002 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;12.5MG Yes No AB 1992/05/19 Prescription
003 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;25MG Yes Yes AB 1992/05/19 Prescription
004 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;12.5MG Yes No AB 1992/05/19 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
2020/08/20 SUPPL-63(补充) Approval Labeling STANDARD
2018/08/08 SUPPL-62(补充) Approval Labeling STANDARD
2017/08/03 SUPPL-61(补充) Approval Labeling STANDARD
2016/06/03 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
2016/05/05 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
2016/02/12 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
2015/08/25 SUPPL-52(补充) Approval Labeling STANDARD
2015/07/07 SUPPL-51(补充) Approval Manufacturing (CMC) STANDARD
2014/12/12 SUPPL-50(补充) Approval Labeling STANDARD
2014/08/14 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
2014/07/22 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
2012/09/21 SUPPL-47(补充) Approval Labeling UNKNOWN
2012/07/27 SUPPL-46(补充) Approval Labeling UNKNOWN
2012/02/16 SUPPL-43(补充) Approval Labeling UNKNOWN
2012/01/19 SUPPL-45(补充) Approval Labeling UNKNOWN
2011/06/14 SUPPL-41(补充) Approval Labeling UNKNOWN
2011/03/17 SUPPL-40(补充) Approval Labeling UNKNOWN
2009/11/10 SUPPL-38(补充) Approval Labeling UNKNOWN
2009/01/22 SUPPL-37(补充) Approval Labeling STANDARD
2008/05/29 SUPPL-36(补充) Approval Labeling STANDARD
2007/02/02 SUPPL-33(补充) Approval Labeling STANDARD
2003/10/29 SUPPL-25(补充) Approval Labeling STANDARD
2002/10/25 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2002/09/20 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
2002/04/29 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2001/12/14 SUPPL-18(补充) Approval Labeling STANDARD
2001/11/30 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
2001/10/16 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2001/08/13 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2000/05/10 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1999/04/28 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1998/07/29 SUPPL-13(补充) Approval Labeling STANDARD
1997/04/09 SUPPL-12(补充) Approval Labeling STANDARD
1997/01/13 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1996/04/02 SUPPL-9(补充) Approval Labeling STANDARD
1995/11/02 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1995/05/05 SUPPL-8(补充) Approval Labeling STANDARD
1993/12/20 SUPPL-7(补充) Approval Labeling STANDARD
1993/10/21 SUPPL-5(补充) Approval Labeling STANDARD
1993/06/30 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1993/01/07 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1992/11/25 SUPPL-4(补充) Approval Labeling STANDARD
1992/06/23 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1992/06/23 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1992/05/19 ORIG-1(原始申请) Approval Type 4 - New Combination 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
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
与本品治疗等效的药品
活性成分:BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:10MG;12.5MG 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
020033 002 NDA LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;12.5MG Prescription Yes No AB 1992/05/19 VALIDUS PHARMS
076342 002 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;12.5MG Prescription No No AB 2004/02/11 ANI PHARMS
076631 002 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;12.5MG Prescription No No AB 2004/02/11 SANDOZ
078794 002 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;12.5MG Prescription No No AB 2014/08/21 APOTEX
活性成分:BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:20MG;25MG 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
020033 003 NDA LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;25MG Prescription Yes Yes AB 1992/05/19 VALIDUS PHARMS
076342 004 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;25MG Prescription No No AB 2004/02/11 ANI PHARMS
076631 004 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;25MG Prescription No No AB 2004/02/11 SANDOZ
078794 004 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;25MG Prescription No No AB 2014/08/21 APOTEX
活性成分:BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:20MG;12.5MG 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
020033 004 NDA LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;12.5MG Prescription Yes No AB 1992/05/19 VALIDUS PHARMS
076342 003 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;12.5MG Prescription No No AB 2004/02/11 ANI PHARMS
076631 003 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;12.5MG Prescription No No AB 2004/02/11 SANDOZ
078794 003 ANDA BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL 20MG;12.5MG Prescription No No AB 2014/08/21 APOTEX
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