药品注册申请号:022083
申请类型:NDA (新药申请)
申请人:SANDOZ
申请人全名:SANDOZ 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 EXELON RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 4.6MG/24HR Yes No AB 2007/07/06 2007/07/06 Prescription
002 EXELON RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 9.5MG/24HR Yes Yes AB 2007/07/06 Prescription
005 EXELON RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 13.3MG/24HR Yes No AB 2012/08/31 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
2024/05/08 SUPPL-28(补充) Approval Labeling STANDARD
2018/12/18 SUPPL-26(补充) Approval Labeling STANDARD
2016/11/02 SUPPL-23(补充) Approval Labeling STANDARD
2015/06/24 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2015/02/03 SUPPL-20(补充) Approval Labeling STANDARD
2013/06/27 SUPPL-19(补充) Approval Efficacy STANDARD
2013/03/13 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
2012/08/31 SUPPL-16(补充) Approval Efficacy STANDARD
2010/08/27 SUPPL-8(补充) Approval Labeling UNKNOWN
2007/07/06 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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 4948807 2012/08/14 Y U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
5602176 2014/02/11 Y Y U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
6316023 2019/01/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6335031 2019/01/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 4948807 2012/08/14 Y U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
5602176 2014/02/11 Y Y U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
6316023 2019/01/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6335031 2019/01/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
005 5602176 2014/02/11 Y Y U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
6316023 2019/01/08 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6335031 2019/01/08 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
001 NDF 2010/07/06**本条是由Drugfuture回溯的历史信息**
002 NDF 2010/07/06**本条是由Drugfuture回溯的历史信息**
005 NPP 2016/06/27**本条是由Drugfuture回溯的历史信息**
NS 2015/08/31**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:RIVASTIGMINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:4.6MG/24HR 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
022083 001 NDA EXELON RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 4.6MG/24HR Prescription Yes No AB 2007/07/06 SANDOZ
204403 001 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 4.6MG/24HR Prescription No No AB 2015/09/03 ALVOGEN
205622 001 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 4.6MG/24HR Prescription No No AB 2018/06/20 MYLAN TECHNOLOGIES
207308 001 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 4.6MG/24HR Prescription No No AB 2019/01/08 AMNEAL PHARMS
206318 001 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 4.6MG/24HR Prescription No No AB 2019/03/04 ZYDUS PHARMS
209063 001 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 4.6MG/24HR Prescription No No AB 2019/11/26 BRECKENRIDGE
活性成分:RIVASTIGMINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:9.5MG/24HR 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
022083 002 NDA EXELON RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 9.5MG/24HR Prescription Yes Yes AB 2007/07/06 SANDOZ
204403 002 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 9.5MG/24HR Prescription No No AB 2015/09/03 ALVOGEN
205622 002 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 9.5MG/24HR Prescription No No AB 2018/06/20 MYLAN TECHNOLOGIES
207308 002 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 9.5MG/24HR Prescription No No AB 2019/01/08 AMNEAL PHARMS
206318 002 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 9.5MG/24HR Prescription No No AB 2019/03/04 ZYDUS PHARMS
209063 002 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 9.5MG/24HR Prescription No No AB 2019/11/26 BRECKENRIDGE
活性成分:RIVASTIGMINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:13.3MG/24HR 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
022083 005 NDA EXELON RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 13.3MG/24HR Prescription Yes No AB 2012/08/31 SANDOZ
204403 003 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 13.3MG/24HR Prescription No No AB 2015/08/31 ALVOGEN
205622 003 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 13.3MG/24HR Prescription No No AB 2018/06/20 MYLAN TECHNOLOGIES
207308 003 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 13.3MG/24HR Prescription No No AB 2019/01/08 AMNEAL PHARMS
206318 003 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 13.3MG/24HR Prescription No No AB 2019/03/04 ZYDUS PHARMS
209063 003 ANDA RIVASTIGMINE RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL 13.3MG/24HR Prescription No No AB 2019/11/26 BRECKENRIDGE
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