药品名称CYTOXAN (LYOPHILIZED)
申请号012142产品号005
活性成分CYCLOPHOSPHAMIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格2GM/VIAL
治疗等效代码参比药物
批准日期1982/08/30申请机构BAXTER HEALTHCARE CORP
化学类型New active ingredient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
012142112APLabel2013/05/09下载
012142112APLetter2013/05/10下载
012142109APLabel2012/04/02下载
012142109APLetter2012/04/04下载
012142107APLetter2003/11/25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
012142114AP2014/07/22Manufacturing Change or Addition
012142112AP2013/05/07Labeling Revision
012142109AP2012/03/31Labeling Revision
012142107AP2003/11/07Formulation Revision
012142104AP2000/11/02Manufacturing Change or Addition
012142103AP2001/01/30Labeling Revision
012142102AP1999/05/28Labeling Revision
012142101AP2000/06/15Labeling Revision
012142098AP1995/12/20Labeling Revision
012142093AP1990/10/22Control Supplement
012142092AP1989/03/01Control Supplement
012142091AP1988/01/12Control Supplement
012142090AP1988/01/11Labeling Revision
012142089AP1987/11/20Control Supplement
012142088AP1987/04/29Manufacturing Change or Addition
012142087AP1986/12/08Labeling Revision
012142086AP1986/12/08Labeling Revision
012142085AP1986/05/30Labeling Revision
012142084AP1986/05/30Labeling Revision
012142083AP1986/07/11Labeling Revision
012142082AP1986/07/11Labeling Revision
012142081AP1986/07/11Labeling Revision
012142080AP1986/05/30Labeling Revision
012142079AP1988/04/28Control Supplement
012142077AP1986/02/14Labeling Revision
012142076AP1985/08/30Labeling Revision
012142075AP1985/08/30Control Supplement
012142074AP1985/05/02Expiration Date Change
012142073AP1985/06/18Control Supplement
012142072AP1985/05/06Expiration Date Change
012142071AP1984/12/10Expiration Date Change
012142070AP1985/12/10Labeling Revision
012142069AP1985/09/24Labeling Revision
012142068AP1985/12/05Labeling Revision
012142067AP1984/07/18Expiration Date Change
012142066AP1984/06/15Manufacturing Change or Addition
012142065AP1984/08/20Control Supplement
012142064AP1984/05/24Control Supplement
012142063AP1984/06/14Labeling Revision
012142061AP1984/10/17Labeling Revision
012142059AP1984/04/05Labeling Revision
012142058AP1984/01/04Formulation Revision
012142057AP1985/08/06Control Supplement
012142056AP1983/03/15Labeling Revision
012142055AP1984/06/14Package Change
012142054AP1982/08/30Package Change
012142053AP1987/04/29Practioner Draft Labeling
012142052AP1982/07/28Control Supplement
012142050AP1981/10/13Control Supplement
012142048AP1981/11/16Control Supplement
012142047AP1981/12/11Package Change
012142046AP1981/03/21Package Change
012142045AP1980/09/27Labeling Revision
012142044AP1979/08/03Control Supplement
012142043AP1979/06/19Manufacturing Change or Addition
012142041AP1979/02/16Control Supplement
012142040AP1978/12/13Control Supplement
012142039AP1979/12/03Control Supplement
012142038AP1978/08/29Control Supplement
012142035AP1977/04/20Control Supplement
012142034AP1977/04/26Control Supplement
012142033AP1977/04/26Manufacturing Change or Addition
012142030AP1976/11/01Labeling Revision
012142029AP1976/06/10Manufacturing Change or Addition
012142028AP1987/04/29New or Modified Indication
012142025AP1976/01/13Control Supplement
012142000AP1959/11/16Approval