药品注册申请号:019221
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH US 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 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Yes Yes AB 1986/10/31 1986/10/31 Prescription
003 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Yes No AB 1995/07/12 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2017/07/21 SUPPL 47 Approval Labeling STANDARD
2015/08/25 SUPPL 45 Approval Labeling STANDARD
2014/12/24 SUPPL 44 Approval Labeling STANDARD
2012/09/13 SUPPL 43 Approval Labeling UNKNOWN
2012/02/17 SUPPL 42 Approval Labeling UNKNOWN
2011/03/11 SUPPL 41 Approval Labeling UNKNOWN
2008/09/25 SUPPL 38 Approval Labeling STANDARD
2007/10/31 SUPPL 37 Approval Labeling STANDARD
2002/11/01 SUPPL 27 Approval Labeling STANDARD
2002/10/15 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2002/02/04 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2001/11/27 SUPPL 26 Approval Labeling STANDARD
1999/02/17 SUPPL 25 Approval Labeling STANDARD
1998/10/13 SUPPL 24 Approval Labeling STANDARD
1997/06/11 SUPPL 23 Approval Labeling STANDARD
1996/07/31 SUPPL 13 Approval Labeling STANDARD
1995/09/28 SUPPL 21 Approval Labeling STANDARD
1995/07/12 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1995/07/12 SUPPL 15 Approval Efficacy UNKNOWN
1994/07/25 SUPPL 20 Approval Labeling STANDARD
1994/05/11 SUPPL 17 Approval Labeling STANDARD
1994/02/18 SUPPL 19 Approval Labeling STANDARD
1994/01/14 SUPPL 16 Approval Labeling STANDARD
1993/10/21 SUPPL 18 Approval Labeling STANDARD
1993/02/24 SUPPL 14 Approval Labeling STANDARD
1992/09/30 SUPPL 12 Approval Labeling
1992/09/30 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1992/05/13 SUPPL 11 Approval Labeling
1992/05/07 SUPPL 10 Approval Labeling
1991/02/06 SUPPL 7 Approval Labeling
1990/03/09 SUPPL 6 Approval Labeling
1989/12/22 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1989/11/30 SUPPL 5 Approval Labeling
1989/04/18 SUPPL 3 Approval Labeling
1989/01/10 SUPPL 2 Approval Labeling
1987/01/30 SUPPL 1 Approval Labeling
1986/10/31 ORIG 1 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:ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:10MG;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
019221 001 NDA VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Prescription Yes Yes AB 1986/10/31 BAUSCH
075624 002 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Prescription No No AB 2001/09/18 MYLAN
075727 002 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Prescription No No AB 2001/09/18 ACP NIMBLE
075788 002 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Prescription No No AB 2001/09/18 TARO PHARM INDS
075909 002 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Prescription No No AB 2001/10/15 DR REDDYS LABS LTD
076486 002 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Prescription No No AB 2004/10/27 APOTEX INC
活性成分:ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:5MG;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
019221 003 NDA VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Prescription Yes No AB 1995/07/12 BAUSCH
075624 001 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Prescription No No AB 2001/09/18 MYLAN
075727 001 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Prescription No No AB 2001/09/18 ACP NIMBLE
075788 001 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Prescription No No AB 2001/09/18 TARO PHARM INDS
075909 001 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Prescription No No AB 2001/10/15 DR REDDYS LABS LTD
076486 001 ANDA ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Prescription No No AB 2004/10/27 APOTEX INC
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