药品名称VALIUM
申请号013263产品号004
活性成分DIAZEPAM市场状态处方药
剂型或给药途径TABLET;ORAL规格5MG
治疗等效代码AB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 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
013263092APLetter2013/10/24下载
013263092APLabel2013/10/25下载
013263086APLetter2002/02/12下载
013263086APReview2007/07/09下载
013263083APLetter2008/05/14下载
013263083APLabel2008/06/05下载
013263082APLetter2001/05/09下载
013263082APReview2006/10/25下载
013263081APReview2007/07/06下载
013263080APLetter2008/05/14下载
013263075APReview2007/07/06下载
013263075APLetter2002/02/07下载
013263072APLetter2004/06/29下载
013263072APReview2007/07/06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
013263093AP2015/07/30Manufacturing Change or Addition
013263092AP2013/10/22Labeling Revision
013263091AP2013/04/19Manufacturing Change or Addition
013263086AP2002/02/12Control Supplement
013263085AP2001/11/08Package Change
013263084AP2001/10/25Manufacturing Change or Addition
013263083AP2008/05/12Labeling Revision
013263082AP2001/05/09Manufacturing Change or Addition
013263081AP2000/08/30Manufacturing Change or Addition
013263080AP2008/05/12Labeling Revision
013263079AP1998/09/04Control Supplement
013263078AP1997/09/19Package Change
013263077AP1997/11/05Manufacturing Change or Addition
013263076AP1997/09/05Control Supplement
013263075AP2002/02/07Labeling Revision
013263074AP1989/10/26Manufacturing Change or Addition
013263073AP1988/11/08Manufacturing Change or Addition
013263072AP2002/02/07Labeling Revision
013263071AP1988/01/20Control Supplement
013263070AP1986/08/27Expiration Date Change
013263069AP1985/04/16Manufacturing Change or Addition
013263068AP1984/01/13Control Supplement
013263067AP1984/01/13Labeling Revision
013263066AP1983/01/20Control Supplement
013263065AP1983/01/20Control Supplement
013263064AP1982/12/10Package Change
013263063AP1982/11/30Package Change
013263062AP1982/10/18Labeling Revision
013263061AP1982/10/18Package Change
013263060AP1982/10/18Package Change
013263059AP1982/10/18Package Change
013263057AP1982/08/11Control Supplement
013263056AP1982/05/11Control Supplement
013263055AP1983/03/04Expiration Date Change
013263054AP1981/03/26Labeling Revision
013263053AP1981/07/17Manufacturing Change or Addition
013263051AP1980/10/14Control Supplement
013263050AP1980/06/17Package Change
013263049AP1980/05/19Labeling Revision
013263048AP1981/01/09Formulation Revision
013263047AP1979/09/20Formulation Revision
013263046AP1979/11/02Labeling Revision
013263045AP1979/04/04Package Change
013263044AP1980/02/26Control Supplement
013263043AP1978/03/30Labeling Revision
013263042AP1977/09/21Labeling Revision
013263041AP1976/12/14Labeling Revision
013263040AP1976/10/27Labeling Revision
013263039AP1976/08/27Labeling Revision
013263038AP1975/08/25Control Supplement
013263037AP1975/06/18Control Supplement
013263036AP1975/01/24Control Supplement
013263034AP1974/12/13Control Supplement
013263000AP1963/11/15Approval