药品名称MYOVIEW 30ML
申请号020372产品号002
活性成分TECHNETIUM TC-99M TETROFOSMIN KIT市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格N/A
治疗等效代码参比药物
批准日期2005/07/07申请机构GE HEALTHCARE
化学类型New molecular entity (NME)审评分类Standard review drug
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
历史专利信息
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
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
020372022APLetter2009/03/05下载
020372022APLabel2009/03/17下载
020372019APLabel2005/07/15下载
020372019APLetter2005/07/15下载
020372015APLetter2003/11/26下载
020372015APLabel2003/12/01下载
020372013APLabel2003/03/05下载
020372013APLetter2003/03/10下载
020372013APReview2003/07/08下载
020372011APLetter2002/05/22下载
020372009APLabel2003/04/22下载
020372003APLetter2001/11/03下载
020372003APLabel2001/11/03下载
020372003APReview2002/03/12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
020372025AP2013/03/08Manufacturing Change or Addition
020372022AP2009/02/26Formulation Revision
020372019AP2005/07/07Formulation Revision
020372015AP2003/11/13Labeling Revision
020372013AP2003/02/28New or Modified Indication
020372012AP2002/11/25Control Supplement
020372011AP2002/05/22Manufacturing Change or Addition
020372010AP2001/12/04Manufacturing Change or Addition
020372009AP2001/08/27Manufacturing Change or Addition
020372008AP2001/04/10Manufacturing Change or Addition
020372007AP2000/09/29Manufacturing Change or Addition
020372006AP2000/04/12Manufacturing Change or Addition
020372005AP2000/04/13Expiration Date Change
020372004AP1999/11/12Control Supplement
020372003AP2001/11/23New or Modified Indication
020372002AP1998/12/09Manufacturing Change or Addition
020372001AP1998/12/07Manufacturing Change or Addition
020372000AP1996/02/09Approval