药品名称LEVATOL
申请号018976产品号001
活性成分PENBUTOLOL SULFATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1987/12/30申请机构AUXILIUM PHARMACEUTICALS LLC
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
018976012APLabel2011/05/05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
018976012AP2011/05/03Labeling Revision
018976009AP2001/02/06Labeling Revision
018976008AP2000/09/25Manufacturing Change or Addition
018976007AP1999/10/29Manufacturing Change or Addition
018976006AP1996/06/07Manufacturing Change or Addition
018976005AP1996/03/12Manufacturing Change or Addition
018976004AP1993/09/15Manufacturing Change or Addition
018976003AP1990/11/07Labeling Revision
018976002AP1989/01/05Labeling Revision
018976001AP1988/10/26Manufacturing Change or Addition
018976000AP1987/12/30Approval