药品名称SANDIMMUNE
申请号050625产品号003
活性成分CYCLOSPORINE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格50MG
治疗等效代码BX参比药物
批准日期1992/11/23申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New dosage form审评分类Priority 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
050625055APLabel2015/04/01下载
050625055APLetter2015/04/02下载
050625053APLetter2013/05/07下载
050625053APLabel2013/05/09下载
050625049APLabel2012/08/31下载
050625049APLetter2012/09/05下载
050625048APLetter2010/05/06下载
050625048APLabel2010/05/07下载
050625047APLabel2009/10/14下载
050625047APLetter2009/11/10下载
050625044APLabel2006/03/10下载
050625044APLetter2006/03/23下载
050625043APLetter2005/07/26下载
050625043APLabel2005/07/26下载
050625040APLabel2004/03/03下载
050625040APLetter2004/06/17下载
050625039APLetter2004/02/27下载
050625039APLabel2004/03/03下载
050625032APLabel2003/03/05下载
050625032APLetter2004/06/17下载
050625030APLabel2003/03/05下载
050625030APLetter2004/06/17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
050625057AP2016/01/06Manufacturing Change or Addition
050625055AP2015/03/31Labeling Revision
050625053AP2013/05/03Labeling Revision
050625049AP2012/08/30Labeling Revision
050625048AP2010/04/30Labeling Revision
050625047AP2009/10/08Labeling Revision
050625044AP2006/03/06Labeling Revision
050625043AP2005/07/19Labeling Revision
050625040AP2004/02/06Labeling Revision
050625039AP2004/02/06Labeling Revision
050625034AP2002/04/12Manufacturing Change or Addition
050625033AP2002/01/16Manufacturing Change or Addition
050625032AP2003/02/14Labeling Revision
050625030AP2003/02/14Labeling Revision
050625029AP2000/06/30Manufacturing Change or Addition
050625028AP1999/12/21Labeling Revision
050625027AP2000/10/04Labeling Revision
050625025AP1998/03/30Manufacturing Change or Addition
050625024AP1996/04/15Control Supplement
050625023AP1996/08/09Labeling Revision
050625022AP1995/11/21Labeling Revision
050625021AP1995/11/21Expiration Date Change
050625020AP1995/01/13Control Supplement
050625019AP1994/11/10Labeling Revision
050625018AP1995/03/07Manufacturing Change or Addition
050625017AP1994/05/09Control Supplement
050625016AP1994/05/09Control Supplement
050625014AP1993/05/17Package Change
050625013AP1992/11/02Package Change
050625012AP1993/03/19Control Supplement
050625011AP1992/11/23Control Supplement
050625010AP1992/02/21Control Supplement
050625009AP1991/06/10Labeling Revision
050625007AP1992/12/30Expiration Date Change
050625006AP1992/12/30Control Supplement
050625003AP1990/08/24Labeling Revision
050625002AP1991/11/21Package Change
050625000AP1990/03/02Approval