药品注册申请号:019558
申请类型:NDA (新药申请)
申请人:MERCK
申请人全名:MERCK RESEARCH LABORATORIES DIV MERCK CO INC
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 PRINIVIL LISINOPRIL TABLET;ORAL 5MG No No AB 1987/12/29 1987/12/29 Prescription
002 PRINIVIL LISINOPRIL TABLET;ORAL 10MG No No AB 1987/12/29 Prescription
003 PRINIVIL LISINOPRIL TABLET;ORAL 20MG No No AB 1987/12/29 Prescription
004 PRINIVIL LISINOPRIL TABLET;ORAL 40MG No No AB 1988/10/25 Prescription
006 PRINIVIL LISINOPRIL TABLET;ORAL 2.5MG No No None 1994/01/28 Discontinued
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
2018/10/12 SUPPL 62 Approval Labeling STANDARD
2017/09/19 SUPPL 61 Approval Labeling STANDARD
2016/10/14 SUPPL 60 Approval Labeling STANDARD
2015/08/28 SUPPL 59 Approval Labeling STANDARD
2015/07/08 SUPPL 57 Approval Labeling STANDARD
2014/08/22 SUPPL 58 Approval Manufacturing (CMC) STANDARD
2013/02/26 SUPPL 56 Approval Labeling STANDARD
2012/06/07 SUPPL 55 Approval Labeling UNKNOWN
2011/11/17 SUPPL 54 Approval Labeling UNKNOWN
2011/06/10 SUPPL 53 Approval Labeling UNKNOWN
2008/10/09 SUPPL 52 Approval Labeling STANDARD
2008/10/09 SUPPL 51 Approval Labeling STANDARD
2007/02/02 SUPPL 50 Approval Labeling STANDARD
2006/10/18 SUPPL 49 Approval Labeling STANDARD
2006/06/16 SUPPL 47 Approval Labeling STANDARD
2005/10/05 SUPPL 46 Approval Labeling STANDARD
2004/05/05 SUPPL 40 Approval Labeling STANDARD
2004/03/02 SUPPL 44 Approval Labeling STANDARD
2003/05/29 SUPPL 43 Approval Efficacy STANDARD
2001/08/23 SUPPL 42 Approval Manufacturing (CMC) STANDARD
2001/08/07 SUPPL 38 Approval Labeling STANDARD
2001/04/26 SUPPL 41 Approval Manufacturing (CMC) STANDARD
2000/06/09 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1999/03/15 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1999/02/17 SUPPL 36 Approval Labeling STANDARD
1996/09/03 SUPPL 35 Approval Labeling STANDARD
1996/09/03 SUPPL 19 Approval Labeling STANDARD
1995/11/24 SUPPL 27 Approval Efficacy STANDARD
1995/11/01 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1995/09/28 SUPPL 33 Approval Labeling STANDARD
1995/09/28 SUPPL 31 Approval Labeling STANDARD
1995/06/26 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1995/06/08 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1995/03/21 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1995/02/22 SUPPL 28 Approval Labeling STANDARD
1994/07/24 SUPPL 26 Approval Labeling STANDARD
1994/05/11 SUPPL 22 Approval Labeling STANDARD
1994/03/10 SUPPL 25 Approval Labeling STANDARD
1994/01/28 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1994/01/14 SUPPL 21 Approval Labeling STANDARD
1993/09/23 SUPPL 24 Approval Labeling STANDARD
1993/06/14 SUPPL 7 Approval Efficacy
1993/03/10 SUPPL 20 Approval Labeling STANDARD
1992/09/30 SUPPL 18 Approval Labeling
1992/09/30 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1992/05/13 SUPPL 17 Approval Labeling
1992/05/07 SUPPL 16 Approval Labeling
1992/01/23 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1991/09/09 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1991/03/28 SUPPL 11 Approval Labeling
1991/02/06 SUPPL 10 Approval Labeling
1991/01/07 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1990/04/11 SUPPL 8 Approval Labeling
1989/08/09 SUPPL 6 Approval Labeling
1989/03/29 SUPPL 4 Approval Labeling
1989/01/31 SUPPL 5 Approval Labeling
1988/10/25 SUPPL 2 Approval Labeling
1988/10/25 SUPPL 1 Approval Labeling
1988/08/19 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1987/12/29 ORIG 1 Approval Type 1 - New Molecular Entity 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
001 PED 2006/11/29**本条是由Drugfuture回溯的历史信息**
002 PED 2006/11/29**本条是由Drugfuture回溯的历史信息**
003 PED 2006/11/29**本条是由Drugfuture回溯的历史信息**
004 PED 2006/11/29**本条是由Drugfuture回溯的历史信息**
006 PED 2006/11/29**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格: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
019558 001 NDA PRINIVIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 1987/12/29 MERCK
019777 001 NDA ZESTRIL LISINOPRIL TABLET;ORAL 5MG Prescription Yes No AB 1988/05/19 ALVOGEN
075994 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 CASI PHARMS INC
076063 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 HIKMA INTL PHARMS
075743 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 PRINSTON INC
076180 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 PRINSTON INC
075944 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
076059 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 WATSON LABS
076102 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/09/30 APOTEX INC
077321 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2005/09/09 LUPIN
077622 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2006/02/22 AUROBINDO
078402 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2007/04/19 WOCKHARDT
202554 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2013/07/30 ACCORD HLTHCARE
203508 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2013/10/29 INVAGEN PHARMS
活性成分:LISINOPRIL 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
019558 002 NDA PRINIVIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 1987/12/29 MERCK
019777 002 NDA ZESTRIL LISINOPRIL TABLET;ORAL 10MG Prescription Yes No AB 1988/05/19 ALVOGEN
075994 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 CASI PHARMS INC
076063 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 HIKMA INTL PHARMS
075743 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 PRINSTON INC
076180 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 PRINSTON INC
075944 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
076059 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 WATSON LABS
076102 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/09/30 APOTEX INC
077321 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2005/09/09 LUPIN
077622 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2006/02/22 AUROBINDO
078402 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2007/04/19 WOCKHARDT
202554 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2013/07/30 ACCORD HLTHCARE
203508 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2013/10/29 INVAGEN PHARMS
活性成分:LISINOPRIL 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
019558 003 NDA PRINIVIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 1987/12/29 MERCK
019777 003 NDA ZESTRIL LISINOPRIL TABLET;ORAL 20MG Prescription Yes No AB 1988/05/19 ALVOGEN
075994 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 CASI PHARMS INC
076063 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 HIKMA INTL PHARMS
075743 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 PRINSTON INC
076164 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 PRINSTON INC
075944 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
076059 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 WATSON LABS
076102 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/09/30 APOTEX INC
077321 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2005/09/09 LUPIN
077622 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2006/02/22 AUROBINDO
078402 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2007/04/19 WOCKHARDT
202554 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2013/07/30 ACCORD HLTHCARE
203508 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2013/10/29 INVAGEN PHARMS
活性成分:LISINOPRIL 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
019777 004 NDA ZESTRIL LISINOPRIL TABLET;ORAL 40MG Prescription Yes Yes AB 1988/05/19 ALVOGEN
019558 004 NDA PRINIVIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 1988/10/25 MERCK
075994 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 CASI PHARMS INC
076063 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 HIKMA INTL PHARMS
075743 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 PRINSTON INC
076164 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 PRINSTON INC
075944 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
076059 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 WATSON LABS
076102 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/09/30 APOTEX INC
077321 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2005/09/09 LUPIN
077622 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2006/02/22 AUROBINDO
078402 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2007/04/19 WOCKHARDT
202554 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2013/07/30 ACCORD HLTHCARE
203508 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2013/10/29 INVAGEN PHARMS
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