药品注册申请号：019777
申请类型：NDA (新药申请)
申请人：TWI PHARMS
申请人全名：TWI PHARMACEUTICALS 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 ZESTRIL LISINOPRIL TABLET;ORAL 5MG Yes No AB 1988/05/19 1988/05/19 Prescription
002 ZESTRIL LISINOPRIL TABLET;ORAL 10MG Yes No AB 1988/05/19 Prescription
003 ZESTRIL LISINOPRIL TABLET;ORAL 20MG Yes No AB 1988/05/19 Prescription
004 ZESTRIL LISINOPRIL TABLET;ORAL 40MG Yes Yes AB 1988/05/19 Prescription
005 ZESTRIL LISINOPRIL TABLET;ORAL 2.5MG Yes No AB 1993/04/29 Prescription
006 ZESTRIL LISINOPRIL TABLET;ORAL 30MG Yes No AB 1999/01/20 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
2017/07/21 SUPPL-76（补充） Approval Labeling STANDARD
2016/04/21 SUPPL-74（补充） Approval Labeling STANDARD
2015/08/25 SUPPL-73（补充） Approval Labeling STANDARD
2014/12/24 SUPPL-64（补充） Approval Labeling STANDARD
2014/06/26 SUPPL-57（补充） Approval Labeling STANDARD
2013/11/05 SUPPL-63（补充） Approval Labeling STANDARD
2012/10/31 SUPPL-61（补充） Approval Labeling UNKNOWN
2012/08/13 SUPPL-62（补充） Approval Labeling STANDARD
2012/05/02 SUPPL-59（补充） Approval Labeling UNKNOWN
2012/03/29 SUPPL-60（补充） Approval Labeling UNKNOWN
2011/08/04 SUPPL-58（补充） Approval Labeling UNKNOWN
2009/11/06 SUPPL-56（补充） Approval Labeling STANDARD
2009/05/20 SUPPL-54（补充） Approval Labeling STANDARD
2007/10/04 SUPPL-53（补充） Approval Labeling STANDARD
2007/07/16 SUPPL-52（补充） Approval Labeling STANDARD
2006/06/16 SUPPL-50（补充） Approval Labeling STANDARD
2005/05/24 SUPPL-49（补充） Approval Labeling STANDARD
2004/03/30 SUPPL-43（补充） Approval Labeling STANDARD
2003/07/01 SUPPL-44（补充） Approval Efficacy STANDARD
2003/07/01 SUPPL-42（补充） Approval Labeling STANDARD
2002/10/17 SUPPL-45（补充） Approval Labeling STANDARD
2000/12/19 SUPPL-40（补充） Approval Manufacturing (CMC) STANDARD
2000/12/15 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
2000/07/27 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
2000/02/07 SUPPL-37（补充） Approval Efficacy STANDARD
1999/11/18 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
1999/02/24 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1999/01/20 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
1998/11/06 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1998/05/01 SUPPL-33（补充） Approval Labeling STANDARD
1997/01/08 SUPPL-32（补充） Approval Labeling STANDARD
1996/10/11 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
1995/11/24 SUPPL-23（补充） Approval Efficacy STANDARD
1995/11/15 SUPPL-30（补充） Approval Labeling STANDARD
1995/10/26 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1995/07/11 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1995/07/11 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1995/06/13 SUPPL-20（补充） Approval Labeling STANDARD
1995/06/05 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1995/03/31 SUPPL-25（补充） Approval Labeling STANDARD
1994/08/05 SUPPL-21（补充） Approval Labeling STANDARD
1994/05/17 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1993/09/23 SUPPL-19（补充） Approval Labeling STANDARD
1993/06/09 SUPPL-7（补充） Approval Efficacy
1993/05/26 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1993/04/29 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1993/03/31 SUPPL-18（补充） Approval Labeling STANDARD
1992/11/18 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1992/06/25 SUPPL-14（补充） Approval Labeling
1992/02/12 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1991/12/11 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1991/07/29 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1991/04/11 SUPPL-10（补充） Approval Labeling
1990/11/08 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1990/10/17 SUPPL-9（补充） Approval Labeling
1989/09/05 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1989/07/20 SUPPL-5（补充） Approval Labeling
1989/04/11 SUPPL-4（补充） Approval Labeling
1989/01/18 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1988/09/20 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1988/06/30 SUPPL-1（补充） Approval Labeling
1988/05/19 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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
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
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**
005 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
019777 001 NDA ZESTRIL LISINOPRIL TABLET;ORAL 5MG Prescription Yes No AB 1988/05/19 TWI PHARMS
075743 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 PRINSTON INC
075752 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Discontinued No No AB 2002/07/01 HERITAGE PHARMA
075903 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 ASCENT PHARMS INC
075944 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
075994 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 CHARTWELL RX
076059 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 WATSON LABS
076164 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/07/01 PRINSTON INC
076102 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2002/09/30 COREPHARMA
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 BIO AG
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
212041 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 5MG Prescription No No AB 2020/09/15 SCIEGEN PHARMS INC
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
019777 002 NDA ZESTRIL LISINOPRIL TABLET;ORAL 10MG Prescription Yes No AB 1988/05/19 TWI PHARMS
075743 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 PRINSTON INC
075752 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Discontinued No No AB 2002/07/01 HERITAGE PHARMA
075903 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 ASCENT PHARMS INC
075944 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
075994 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 CHARTWELL RX
076059 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 WATSON LABS
076164 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/07/01 PRINSTON INC
076102 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2002/09/30 COREPHARMA
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 BIO AG
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
212041 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 10MG Prescription No No AB 2020/09/15 SCIEGEN PHARMS INC
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
019777 003 NDA ZESTRIL LISINOPRIL TABLET;ORAL 20MG Prescription Yes No AB 1988/05/19 TWI PHARMS
075743 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 PRINSTON INC
075752 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Discontinued No No AB 2002/07/01 HERITAGE PHARMA
075903 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 ASCENT PHARMS INC
075944 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
075994 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 CHARTWELL RX
076059 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 WATSON LABS
076164 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/07/01 PRINSTON INC
076102 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2002/09/30 COREPHARMA
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 BIO AG
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
208920 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 20MG Prescription No No AB 2021/03/04 SCIEGEN PHARMS INC
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 TWI PHARMS
075743 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 PRINSTON INC
075752 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Discontinued No No AB 2002/07/01 HERITAGE PHARMA
075903 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 ASCENT PHARMS INC
075944 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
075994 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 CHARTWELL RX
076059 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 WATSON LABS
076164 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/07/01 PRINSTON INC
076102 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2002/09/30 COREPHARMA
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 BIO AG
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
208920 003 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 40MG Prescription No No AB 2021/03/04 SCIEGEN PHARMS INC
活性成分:LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
019777 005 NDA ZESTRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription Yes No AB 1993/04/29 TWI PHARMS
075743 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2002/07/01 PRINSTON INC
075752 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Discontinued No No AB 2002/07/01 HERITAGE PHARMA
075903 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2002/07/01 ASCENT PHARMS INC
075944 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2002/07/01 SUN PHARM INDS LTD
075994 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2002/07/01 CHARTWELL RX
076059 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2002/07/01 WATSON LABS
076164 004 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2002/07/01 PRINSTON INC
076102 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2002/09/30 COREPHARMA
077321 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2005/09/09 LUPIN
077622 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2006/02/22 AUROBINDO
078402 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2007/04/19 WOCKHARDT BIO AG
202554 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2013/07/30 ACCORD HLTHCARE
203508 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2013/10/29 INVAGEN PHARMS
212041 001 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 2.5MG Prescription No No AB 2020/09/15 SCIEGEN PHARMS INC
活性成分:LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:30MG 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 006 NDA ZESTRIL LISINOPRIL TABLET;ORAL 30MG Prescription Yes No AB 1999/01/20 TWI PHARMS
075743 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2002/07/01 PRINSTON INC
075752 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Discontinued No No AB 2002/07/01 HERITAGE PHARMA
075903 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2002/07/01 ASCENT PHARMS INC
076164 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2002/07/01 PRINSTON INC
075994 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2002/07/01 CHARTWELL RX
076059 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2002/07/01 WATSON LABS
076102 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2002/09/30 COREPHARMA
075944 006 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2003/02/11 SUN PHARM INDS LTD
077321 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2005/09/09 LUPIN
077622 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2006/02/22 AUROBINDO
078402 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2007/04/19 WOCKHARDT BIO AG
202554 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2013/07/30 ACCORD HLTHCARE
203508 005 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2013/10/29 INVAGEN PHARMS
208920 002 ANDA LISINOPRIL LISINOPRIL TABLET;ORAL 30MG Prescription No No AB 2021/03/04 SCIEGEN PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
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