药品名称PLATINOL
申请号018057产品号002
活性成分CISPLATIN市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格50MG/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HQ SPECIALTY PHARMA CORP
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
018057083APLetter2015/02/27下载
018057083APLabel2015/03/02下载
018057081APLetter2012/01/03下载
018057081APLabel2012/01/11下载
018057080APLabel2011/08/30下载
018057080APLetter2011/08/31下载
018057079APLetter2010/09/07下载
018057079APLabel2010/09/07下载
018057076APLetter2002/11/08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
018057085AP2015/10/06Manufacturing Change or Addition
018057084AP2015/03/03Manufacturing Change or Addition
018057083AP2015/02/26Labeling Revision
018057082AP2014/02/06Manufacturing Change or Addition
018057081AP2011/12/29Labeling Revision
018057080AP2011/08/26Labeling Revision
018057079AP2010/09/02Labeling Revision
018057076AP2002/11/08Labeling Revision
018057075AP2001/01/16Manufacturing Change or Addition
018057074AP2000/09/13Package Change
018057072AP1999/05/05Labeling Revision
018057066AP1996/04/18Manufacturing Change or Addition
018057065AP1995/08/09Labeling Revision
018057064AP1995/12/04Manufacturing Change or Addition
018057063AP1995/12/13Manufacturing Change or Addition
018057062AP1993/05/17Labeling Revision
018057061AP1993/04/22New Dosage Regimen
018057060AP1993/03/25Labeling Revision
018057059AP1991/11/01Package Change
018057058AP1990/05/29Control Supplement
018057057AP1991/07/11Control Supplement
018057056AP1992/07/27Labeling Revision
018057055AP1990/09/27Control Supplement
018057053AP1991/11/27Control Supplement
018057052AP1990/04/04Manufacturing Change or Addition
018057051AP1990/12/11Labeling Revision
018057050AP1988/01/12Control Supplement
018057049AP1989/03/02Labeling Revision
018057047AP1988/11/08Control Supplement
018057046AP1987/04/10Labeling Revision
018057045AP1988/01/13Manufacturing Change or Addition
018057044AP1988/05/05Manufacturing Change or Addition
018057043AP1987/03/23Labeling Revision
018057042AP1986/11/06Labeling Revision
018057041AP1986/08/19Labeling Revision
018057040AP1987/06/08Manufacturing Change or Addition
018057039AP1986/08/26Labeling Revision
018057038AP1986/01/22Labeling Revision
018057035AP1987/03/05Package Change
018057033AP1985/09/16Manufacturing Change or Addition
018057032AP1985/07/03Labeling Revision
018057029AP1985/03/05Control Supplement
018057028AP1985/03/05Control Supplement
018057027AP1988/02/11Expiration Date Change
018057026AP1983/10/31Labeling Revision
018057024AP1984/04/04Control Supplement
018057023AP1984/07/18Control Supplement
018057022AP1985/08/23Labeling Revision
018057021AP1986/05/02Control Supplement
018057020AP1984/02/27Labeling Revision
018057019AP1983/01/13Control Supplement
018057017AP1982/06/10Manufacturing Change or Addition
018057012AP1981/12/29General Efficacy (MarkIV)
018057011AP1981/03/12Labeling Revision
018057010AP1980/07/04Package Change
018057009AP1980/09/16Labeling Revision
018057007AP1981/01/22Expiration Date Change
018057006AP1980/02/26Labeling Revision
018057005AP1980/01/31Labeling Revision
018057004AP1980/01/31Manufacturing Change or Addition
018057003AP1979/12/05Manufacturing Change or Addition
018057002AP1979/12/18Labeling Revision
018057001AP1979/09/11Manufacturing Change or Addition
018057000AP1978/12/19Approval