药品注册申请号：021615
申请类型：NDA (新药申请)
申请人：JANSSEN PHARMS
申请人全名：JANSSEN 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 RAZADYNE ER GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2005/04/01 2005/04/01 Discontinued
002 RAZADYNE ER GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2005/04/01 Discontinued
003 RAZADYNE ER GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2005/04/01 Discontinued
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
2022/09/26 SUPPL-27（补充） Approval Labeling STANDARD
2021/08/03 SUPPL-26（补充） Approval Labeling STANDARD
2020/03/20 SUPPL-25（补充） Approval Labeling STANDARD
2020/02/21 SUPPL-24（补充） Approval Labeling STANDARD
2017/02/14 SUPPL-23（补充） Approval Labeling STANDARD
2015/12/15 SUPPL-22（补充） Approval Labeling STANDARD
2015/02/09 SUPPL-21（补充） Approval Labeling STANDARD
2013/06/28 SUPPL-16（补充） Approval Labeling STANDARD
2013/05/21 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2012/03/01 SUPPL-18（补充） Approval Labeling STANDARD
2012/03/01 SUPPL-9（补充） Approval Labeling STANDARD
2012/03/01 SUPPL-8（补充） Approval Labeling STANDARD
2006/04/27 SUPPL-5（补充） Approval Labeling STANDARD
2006/04/27 SUPPL-4（补充） Approval Labeling STANDARD
2006/04/27 SUPPL-3（补充） Approval Labeling STANDARD
2006/04/27 SUPPL-1（补充） Approval Labeling STANDARD
2005/05/02 SUPPL-2（补充） Approval Labeling STANDARD
2005/04/01 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 4663318 2008/12/14 U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
7160559 2019/12/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 4663318 2008/12/14 U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
7160559 2019/12/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 4663318 2008/12/14 U-322 PDF格式**本条是由Drugfuture回溯的历史信息**
7160559 2019/12/20 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 2008/04/01**本条是由Drugfuture回溯的历史信息**
002 NDF 2008/04/01**本条是由Drugfuture回溯的历史信息**
003 NDF 2008/04/01**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:GALANTAMINE HYDROBROMIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
021615 001 NDA RAZADYNE ER GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2005/04/01 JANSSEN PHARMS
活性成分:GALANTAMINE HYDROBROMIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
021615 002 NDA RAZADYNE ER GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2005/04/01 JANSSEN PHARMS
活性成分:GALANTAMINE HYDROBROMIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
021615 003 NDA RAZADYNE ER GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2005/04/01 JANSSEN PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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