药品名称THYROGEN
申请号020898产品号001
活性成分THYROTROPIN ALFA市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格1.1MG/VIAL
治疗等效代码参比药物
批准日期1998/11/30申请机构GENZYME CORP
化学类型New molecular entity (NME)审评分类Priority 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
58405662015/11/24PDF格式
历史专利信息
63651272015/11/24YYU-556PDF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
历史市场独占权保护信息
I-5522010/12/14
M-532009/01/23
ODE2014/12/14
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
020898054APLetter2014/03/24下载
020898054APLabel2014/03/25下载
020898051APLetter2012/07/31下载
020898051APLabel2012/07/31下载
020898038APLetter2008/08/19下载
020898038APLabel2008/08/29下载
020898031APLabel2006/01/25下载
020898031APLetter2006/01/30下载
020898029APLabel2007/12/27下载
020898029APLetter2008/01/09下载
020898021APLetter2004/03/16下载
020898021APLabel2004/04/05下载
020898000APLetter1998/11/30下载
020898000APReview2001/06/19下载
020898000APLabel1998/11/30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
020898059AP2016/10/06Manufacturing Change or Addition
020898057AP2016/08/15Manufacturing Change or Addition
020898056AP2013/06/12Manufacturing Change or Addition
020898055AP2013/05/07Manufacturing Change or Addition
020898054AP2014/03/21Efficacy Supplement with Clinical Data to Support
020898053AP2012/12/14Manufacturing Change or Addition
020898051AP2012/07/27Labeling Revision
020898038AP2008/08/12Labeling Revision
020898031AP2006/01/24Efficacy Supplement with Clinical Data to Support
020898029AP2007/12/14New or Modified Indication
020898021AP2004/03/11Labeling Revision
020898014AP2002/10/08Manufacturing Change or Addition
020898013AP2002/06/25Control Supplement
020898012AP2001/09/17Manufacturing Change or Addition
020898011AP2001/06/13Control Supplement
020898010AP2001/03/15Control Supplement
020898009AP2001/03/01Control Supplement
020898008AP2001/03/01Control Supplement
020898007AP2001/02/28Control Supplement
020898005AP2001/10/26Labeling Revision
020898004AP2000/05/25Control Supplement
020898003AP1999/11/16Control Supplement
020898002AP1999/09/02Control Supplement
020898001AP1999/09/03Manufacturing Change or Addition
020898000AP1998/11/30Approval