药品注册申请号：020356
申请类型：NDA (新药申请)
申请人：COVIS
申请人全名：COVIS PHARMA GMBH
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 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1995/02/02 1995/02/02 Discontinued
002 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1995/02/02 Discontinued
003 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1995/02/02 Discontinued
004 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1995/02/02 Discontinued
005 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 34MG Yes Yes AB 2008/01/02 Prescription
006 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2008/01/02 Discontinued
007 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 17MG Yes Yes AB 2008/01/02 Prescription
008 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 8.5MG Yes Yes AB 2008/01/02 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
2017/06/13 SUPPL-27（补充） Approval Labeling STANDARD
2016/05/20 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
2008/01/02 SUPPL-19（补充） Approval Manufacturing (CMC) N/A
2002/10/11 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
2002/08/13 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2001/03/14 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
2000/09/26 SUPPL-11（补充） Approval Labeling STANDARD
2000/01/19 SUPPL-8（补充） Approval Labeling STANDARD
2000/01/19 SUPPL-7（补充） Approval Labeling STANDARD
1999/12/13 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1998/12/16 SUPPL-9（补充） Approval Labeling STANDARD
1997/02/19 SUPPL-5（补充） Approval Labeling STANDARD
1997/01/24 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1996/10/23 SUPPL-4（补充） Approval Labeling STANDARD
1996/01/05 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1995/12/05 SUPPL-2（补充） Approval Labeling STANDARD
1995/07/26 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1995/02/02 ORIG-1（原始申请） 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
001 4892741 2008/06/08 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4892741 2008/06/08 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4892741 2008/06/08 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4892741 2008/06/08 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5422123 2012/06/06 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5626874 2014/11/30 Y PDF格式**本条是由Drugfuture回溯的历史信息**
006 5422123 2012/06/06 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5626874 2014/11/30 Y PDF格式**本条是由Drugfuture回溯的历史信息**
007 5422123 2012/06/06 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5626874 2014/11/30 Y PDF格式**本条是由Drugfuture回溯的历史信息**
008 5422123 2012/06/06 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5626874 2014/11/30 Y PDF格式**本条是由Drugfuture回溯的历史信息**
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:NISOLDIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:34MG 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
020356 005 NDA SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 34MG Prescription Yes Yes AB 2008/01/02 COVIS
091001 004 ANDA NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 34MG Prescription No No AB 2011/01/26 MYLAN
活性成分:NISOLDIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:17MG 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
020356 007 NDA SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 17MG Prescription Yes Yes AB 2008/01/02 COVIS
091001 002 ANDA NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 17MG Prescription No No AB 2011/01/26 MYLAN
活性成分:NISOLDIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:8.5MG 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
020356 008 NDA SULAR NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 8.5MG Prescription Yes Yes AB 2008/01/02 COVIS
091001 001 ANDA NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 8.5MG Prescription No No AB 2011/01/26 MYLAN
216606 001 ANDA NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE;ORAL 8.5MG Discontinued No No AB 2023/04/10 AMTA
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
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