药品名称ROCALTROL
申请号018044产品号001
活性成分CALCITRIOL市场状态处方药
剂型或给药途径CAPSULE;ORAL规格0.25MCG
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VALIDUS PHARMACEUTICALS LLC
化学类型New molecular entity (NME)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
018044038APLetter2010/03/03下载
018044032APLetter2004/07/08下载
018044028APLetter2002/02/01下载
018044025APLetter2004/06/16下载
018044024APReview1998/05/06下载
018044019APReview1998/05/06下载
018044018APReview1998/05/06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
018044038AP2010/02/22Labeling Revision
018044032AP2004/07/07Labeling Revision
018044030AP2001/11/12Package Change
018044029AP2001/10/15Manufacturing Change or Addition
018044028AP2002/02/01Labeling Revision
018044027AP2000/12/15Control Supplement
018044026AP1999/04/27Manufacturing Change or Addition
018044025AP1998/11/20New or Modified Indication
018044024AP1996/10/22Labeling Revision
018044023AP1995/05/26Control Supplement
018044022AP1995/12/15Control Supplement
018044021AP1993/09/24Control Supplement
018044020AP1991/09/24Control Supplement
018044019AP1990/03/13Control Supplement
018044018AP1991/04/08Labeling Revision
018044017AP1988/04/27Labeling Revision
018044016AP1988/04/27Control Supplement
018044015AP1986/05/16Labeling Revision
018044014AP1985/12/20Manufacturing Change or Addition
018044012AP1986/01/22General Efficacy (MarkIV)
018044011AP1984/08/20Package Change
018044010AP1986/09/16Control Supplement
018044009AP1983/11/04Labeling Revision
018044008AP1982/04/22Labeling Revision
018044006AP1980/12/10Control Supplement
018044005AP1980/05/12Manufacturing Change or Addition
018044002AP1979/11/09Control Supplement
018044001AP1978/12/06Control Supplement
018044000AP1978/08/17Approval