药品名称CEREDASE
申请号020057产品号004
活性成分ALGLUCERASE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格10 UNITS/ML
治疗等效代码参比药物
批准日期1992/05/08申请机构GENZYME CORPORATION
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药
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
020057034APLabel2006/02/22下载
020057034APLetter2006/02/22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
020057037AP2002/01/30Control Supplement
020057036AP2001/09/24Control Supplement
020057035AP1999/04/30Expiration Date Change
020057034AP2006/02/09Labeling Revision
020057033AP1996/11/27Control Supplement
020057032AP1996/07/23Manufacturing Change or Addition
020057031AP1996/09/11Labeling Revision
020057030AP1996/07/03Control Supplement
020057028AP1996/05/21Control Supplement
020057027AP1996/03/26Control Supplement
020057026AP1995/12/21Control Supplement
020057025AP1995/11/09Control Supplement
020057024AP1995/10/16Control Supplement
020057023AP1995/06/08Labeling Revision
020057022AP1995/06/19Manufacturing Change or Addition
020057021AP1994/12/14Labeling Revision
020057020AP1995/10/26Control Supplement
020057019AP1994/12/06Control Supplement
020057018AP1994/08/03Control Supplement
020057017AP1994/01/07Formulation Revision
020057015AP1994/05/17Control Supplement
020057014AP1996/02/28Labeling Revision
020057013AP1993/10/01Control Supplement
020057012AP1994/01/07Manufacturing Change or Addition
020057011AP1994/05/17Manufacturing Change or Addition
020057010AP1993/06/16Control Supplement
020057009AP1993/05/28Expiration Date Change
020057008AP1993/06/30Manufacturing Change or Addition
020057007AP1993/06/09Control Supplement
020057006AP1995/06/19Labeling Revision
020057005AP1993/06/30Control Supplement
020057004AP1992/05/08Package Change
020057002AP1991/09/24Expiration Date Change
020057001AP1991/11/27Manufacturing Change or Addition
020057000AP1991/04/05Approval