药品名称COPAXONE
申请号020622产品号003
活性成分GLATIRAMER ACETATE市场状态处方药
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格40MG/ML
治疗等效代码参比药物
批准日期2014/01/28申请机构TEVA PHARMACEUTICALS USA
化学类型New molecular entity (NME)审评分类Standard review drug
罕用药/孤儿药
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
82322502030/08/19U-441PDF格式
83994132030/08/19U-441PDF格式
89693022030/08/19U-441PDF格式
91557762030/08/19U-441PDF格式
94028742030/08/19U-441PDF格式
历史专利信息
60544302014/05/24YPDF格式
63424762014/05/24U-441PDF格式
63621612014/05/24YPDF格式
71990982014/05/24YPDF格式
83676052014/05/24YPDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
NP2017/01/28
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
020622089APLetter2014/01/29下载
020622089APLabel2014/01/31下载
020622087APLabel2013/03/12下载
020622057APLetter2009/03/03下载
020622057APLabel2009/03/17下载
020622026APLetter2002/08/29下载
020622023APLetter2002/02/12下载
020622015APLabel2003/04/28下载
020622015APReview2007/04/09下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
020622097AP2016/10/24Manufacturing Change or Addition
020622096AP2015/10/02Manufacturing Change or Addition
020622095AP2015/12/03Manufacturing Change or Addition
020622094AP2015/08/03Manufacturing Change or Addition
020622093AP2016/03/14Manufacturing Change or Addition
020622092AP2015/01/26Manufacturing Change or Addition
020622091AP2013/12/06Manufacturing Change or Addition
020622089AP2014/01/28Efficacy Supplement with Clinical Data to Support
020622087AP2013/03/08Manufacturing Change or Addition
020622085AP2013/09/05Manufacturing Change or Addition
020622083AP2013/09/05Manufacturing Change or Addition
020622079AP2013/02/22Manufacturing Change or Addition
020622057AP2009/02/27New or Modified Indication
020622026AP2002/08/29Labeling Revision
020622025AP2002/05/20Manufacturing Change or Addition
020622024AP2002/03/11Manufacturing Change or Addition
020622023AP2002/02/12Formulation Revision
020622022AP2001/06/12Labeling Revision
020622020AP2001/02/28Labeling Revision
020622019AP2001/02/23Manufacturing Change or Addition
020622018AP2001/01/25Control Supplement
020622017AP1999/11/29Manufacturing Change or Addition
020622016AP1999/09/24Manufacturing Change or Addition
020622015AP2001/07/12Labeling Revision
020622014AP1999/08/16Control Supplement
020622013AP1999/08/16Manufacturing Change or Addition
020622012AP1999/08/04Manufacturing Change or Addition
020622011AP1999/08/03Manufacturing Change or Addition
020622010AP1999/07/30Control Supplement
020622009AP2000/07/06Labeling Revision
020622008AP1999/06/28Manufacturing Change or Addition
020622007AP2000/08/09Labeling Revision
020622006AP1999/02/25Control Supplement
020622005AP1999/02/16Manufacturing Change or Addition
020622004AP2000/07/06Labeling Revision
020622003AP1998/01/23Manufacturing Change or Addition
020622002AP1998/01/23Control Supplement
020622001AP1997/11/04Control Supplement
020622000AP1996/12/20Approval