药品名称VALIUM
申请号016087产品号001
活性成分DIAZEPAM市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HOFFMANN LA ROCHE INC
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
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
016087081APLetter2002/02/07下载
016087079APLetter2002/02/07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
016087084AP1998/09/04Control Supplement
016087083AP1997/09/17Control Supplement
016087082AP1997/11/05Manufacturing Change or Addition
016087081AP2002/02/07Labeling Revision
016087080AP1993/05/25Control Supplement
016087079AP2002/02/07Labeling Revision
016087078AP1987/04/23Control Supplement
016087077AP1987/10/27Control Supplement
016087076AP1986/10/29Control Supplement
016087074AP1986/06/16Control Supplement
016087072AP1986/06/16Package Change
016087071AP1986/01/15Package Change
016087070AP1985/08/06Manufacturing Change or Addition
016087069AP1985/06/27Labeling Revision
016087068AP1985/05/31Manufacturing Change or Addition
016087067AP1985/06/26Control Supplement
016087066AP1985/06/26Control Supplement
016087063AP1983/04/18Package Change
016087062AP1983/03/29Control Supplement
016087061AP1983/03/14Labeling Revision
016087060AP1983/03/14Labeling Revision
016087059AP1983/03/14Labeling Revision
016087058AP1983/04/06Labeling Revision
016087057AP1983/03/01Manufacturing Change or Addition
016087056AP1982/10/29Control Supplement
016087054AP1982/08/20Control Supplement
016087053AP1982/10/27Manufacturing Change or Addition
016087052AP1982/05/18Control Supplement
016087051AP1982/08/05Labeling Revision
016087050AP1981/11/19Package Change
016087049AP1981/11/12Labeling Revision
016087048AP1981/11/13Labeling Revision
016087047AP1981/08/24Package Change
016087046AP1981/04/16Control Supplement
016087045AP1981/03/26Labeling Revision
016087044AP1981/04/16Manufacturing Change or Addition
016087043AP1981/04/20Manufacturing Change or Addition
016087042AP1980/05/19Labeling Revision
016087041AP1979/07/20Labeling Revision
016087040AP1979/11/02Labeling Revision
016087039AP1979/05/31Labeling Revision
016087038AP1979/04/09Manufacturing Change or Addition
016087037AP1979/03/23Labeling Revision
016087036AP1980/03/15Control Supplement
016087035AP1978/10/24Control Supplement
016087033AP1977/10/18Package Change
016087030AP1976/07/23Formulation Revision
016087029AP1976/04/23Package Change
016087028AP1975/11/13Control Supplement
016087027AP1975/05/01Control Supplement
016087026AP1974/12/02Control Supplement
016087025AP1974/11/15Control Supplement
016087023AP1974/06/05Labeling Revision
016087022AP1974/06/20Labeling Revision
016087000AP1966/08/24Approval