药品名称ZOLADEX
申请号020578产品号001
活性成分GOSERELIN ACETATE市场状态处方药
剂型或给药途径IMPLANT;IMPLANTATION规格EQ 10.8MG BASE
治疗等效代码参比药物
批准日期1996/01/11申请机构ASTRAZENECA UK LTD
化学类型New dosage form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
72202472022/04/09YPDF格式
71185522022/04/13YPDF格式
75009642021/02/26YPDF格式
历史专利信息
53667342011/11/22PDF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
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
020578037APLabel2015/02/13下载
020578037APLetter2015/02/17下载
020578036APLetter2014/10/09下载
020578036APLabel2014/10/09下载
020578035APLetter2013/06/20下载
020578035APLabel2013/06/17下载
020578034APLetter2013/06/20下载
020578034APLabel2013/06/17下载
020578032APLetter2011/01/20下载
020578032APLabel2011/01/20下载
020578030APLabel2009/09/17下载
020578030APLetter2010/01/20下载
020578029APLetter2010/01/20下载
020578029APLabel2009/09/17下载
020578028APLabel2009/09/17下载
020578028APLetter2010/01/20下载
020578025APLetter2005/10/25下载
020578020APLetter2004/06/25下载
020578016APLetter2002/02/28下载
020578013APLetter2002/02/05下载
020578003APLetter1998/07/27下载
020578003APLabel1998/07/27下载
020578003APReview1998/07/27下载
020578000APOther Important Information from FDA2011/12/20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
020578037AP2015/02/12Labeling Revision
020578036AP2014/10/07Labeling Revision
020578035AP2013/06/18Labeling Revision
020578034AP2013/06/18Labeling Revision
020578032AP2011/01/14Labeling Revision
020578030AP2009/08/31Labeling Revision
020578029AP2009/08/31Labeling Revision
020578028AP2009/08/31Labeling Revision
020578025AP2005/10/19Labeling Revision
020578020AP2004/06/24Labeling Revision
020578016AP2002/02/28Labeling Revision
020578013AP2002/02/05Labeling Revision
020578012AP2001/03/09Manufacturing Change or Addition
020578011AP2000/10/16Control Supplement
020578010AP2000/06/20Control Supplement
020578009AP1999/11/03Labeling Revision
020578008AP1999/03/04Manufacturing Change or Addition
020578007AP1998/12/07Manufacturing Change or Addition
020578006AP1998/09/18Manufacturing Change or Addition
020578005AP1998/07/16Manufacturing Change or Addition
020578004AP1997/11/13Control Supplement
020578003AP1998/07/27New or Modified Indication
020578002AP1997/06/09Control Supplement
020578001AP1999/04/14Labeling Revision
020578000AP1996/01/11Approval