药品名称METHOTREXATE SODIUM
申请号011719产品号003
活性成分METHOTREXATE SODIUM市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 50MG BASE/VIAL
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HOSPIRA INC
化学类型New active ingredient审评分类Standard 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
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
011719122APLetter2015/11/23下载
011719122APLabel2015/11/25下载
011719117APLetter2011/11/03下载
011719117APLabel2011/11/04下载
011719108APLetter2005/04/19下载
011719107APLetter2004/12/30下载
011719106APLetter2004/02/02下载
011719106APLabel2004/02/03下载
011719105APLetter2003/08/06下载
011719104APLetter2003/01/03下载
011719103APLetter2002/02/20下载
011719102APLetter2002/02/20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
011719124AP2016/02/03Manufacturing Change or Addition
011719122AP2015/11/20Labeling Revision
011719121AP2015/08/14Manufacturing Change or Addition
011719117AP2011/11/01Labeling Revision
011719108AP2005/04/13Manufacturing Change or Addition
011719107AP2004/12/15Manufacturing Change or Addition
011719106AP2004/01/27Labeling Revision
011719105AP2003/07/30Labeling Revision
011719104AP2003/01/03Labeling Revision
011719103AP2002/02/20Labeling Revision
011719102AP2002/02/20Labeling Revision
011719100AP2001/05/08Labeling Revision
011719099AP1999/10/29Labeling Revision
011719098AP1999/02/12Control Supplement
011719097AP1998/06/22Manufacturing Change or Addition
011719096AP2000/11/08Labeling Revision
011719095AP1997/05/20Labeling Revision
011719094AP1995/04/25Control Supplement
011719089AP1992/01/23Manufacturing Change or Addition
011719086AP1991/11/05Package Change
011719085AP1990/10/24Control Supplement
011719083AP1991/02/20Control Supplement
011719081AP1989/03/01Control Supplement
011719079AP1988/04/21Formulation Revision
011719078AP1988/04/07Control Supplement
011719077AP1988/04/07New or Modified Indication
011719076AP1990/01/18Labeling Revision
011719075AP1986/12/08Manufacturing Change or Addition
011719074AP1987/08/18Manufacturing Change or Addition
011719073AP1986/09/16Labeling Revision
011719071AP1986/09/16Manufacturing Change or Addition
011719070AP1987/03/19Manufacturing Change or Addition
011719063AP1983/04/08Control Supplement
011719062AP1982/08/24Labeling Revision
011719059AP1983/04/08Manufacturing Change or Addition
011719058AP1982/03/31Control Supplement
011719057AP1982/03/31Labeling Revision
011719056AP1981/12/07Manufacturing Change or Addition
011719054AP1981/05/11Manufacturing Change or Addition
011719053AP1980/12/03Expiration Date Change
011719052AP1980/02/29Control Supplement
011719051AP1979/10/15Manufacturing Change or Addition
011719050AP1980/06/11Manufacturing Change or Addition
011719049AP1979/02/15Control Supplement
011719047AP1978/12/14Control Supplement
011719046AP1978/08/08Manufacturing Change or Addition
011719043AP1979/01/02Control Supplement
011719039AP1978/08/22Control Supplement
011719038AP1977/07/14Manufacturing Change or Addition
011719037AP1977/03/18Control Supplement
011719036AP1977/03/28Manufacturing Change or Addition
011719035AP1977/08/02Manufacturing Change or Addition
011719033AP1976/09/14Control Supplement
011719032AP1976/09/14Control Supplement
011719031AP1976/09/07Control Supplement
011719030AP1976/09/07Manufacturing Change or Addition
011719029AP1976/09/07Control Supplement
011719028AP1976/06/29Control Supplement
011719027AP1976/08/03Manufacturing Change or Addition
011719026AP1976/06/29Labeling Revision
011719025AP1976/06/29Manufacturing Change or Addition
011719024AP1975/12/05Labeling Revision
011719023AP1975/11/03Labeling Revision
011719022AP1975/11/03Final Printed Labeling - MarkIV
011719021AP1975/07/22Control Supplement
011719000AP1959/08/10Approval