| 药品名称 | CEREDASE | | 申请号 | 020057 | 产品号 | 003 | | 活性成分 | ALGLUCERASE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 80 UNITS/ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1991/04/05 | 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 | 是 | | |
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| 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 | | 无 | | 历史专利信息 | | 无 |
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| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | 无 | | 历史市场独占权保护信息 | | 无 |
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| 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 | | 020057 | 034 | AP | Label | 2006/02/22 | 下载 | | 020057 | 034 | AP | Letter | 2006/02/22 | 下载 |
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| 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 | | 020057 | 037 | AP | 2002/01/30 | Control Supplement | | 020057 | 036 | AP | 2001/09/24 | Control Supplement | | 020057 | 035 | AP | 1999/04/30 | Expiration Date Change | | 020057 | 034 | AP | 2006/02/09 | Labeling Revision | | 020057 | 033 | AP | 1996/11/27 | Control Supplement | | 020057 | 032 | AP | 1996/07/23 | Manufacturing Change or Addition | | 020057 | 031 | AP | 1996/09/11 | Labeling Revision | | 020057 | 030 | AP | 1996/07/03 | Control Supplement | | 020057 | 028 | AP | 1996/05/21 | Control Supplement | | 020057 | 027 | AP | 1996/03/26 | Control Supplement | | 020057 | 026 | AP | 1995/12/21 | Control Supplement | | 020057 | 025 | AP | 1995/11/09 | Control Supplement | | 020057 | 024 | AP | 1995/10/16 | Control Supplement | | 020057 | 023 | AP | 1995/06/08 | Labeling Revision | | 020057 | 022 | AP | 1995/06/19 | Manufacturing Change or Addition | | 020057 | 021 | AP | 1994/12/14 | Labeling Revision | | 020057 | 020 | AP | 1995/10/26 | Control Supplement | | 020057 | 019 | AP | 1994/12/06 | Control Supplement | | 020057 | 018 | AP | 1994/08/03 | Control Supplement | | 020057 | 017 | AP | 1994/01/07 | Formulation Revision | | 020057 | 015 | AP | 1994/05/17 | Control Supplement | | 020057 | 014 | AP | 1996/02/28 | Labeling Revision | | 020057 | 013 | AP | 1993/10/01 | Control Supplement | | 020057 | 012 | AP | 1994/01/07 | Manufacturing Change or Addition | | 020057 | 011 | AP | 1994/05/17 | Manufacturing Change or Addition | | 020057 | 010 | AP | 1993/06/16 | Control Supplement | | 020057 | 009 | AP | 1993/05/28 | Expiration Date Change | | 020057 | 008 | AP | 1993/06/30 | Manufacturing Change or Addition | | 020057 | 007 | AP | 1993/06/09 | Control Supplement | | 020057 | 006 | AP | 1995/06/19 | Labeling Revision | | 020057 | 005 | AP | 1993/06/30 | Control Supplement | | 020057 | 004 | AP | 1992/05/08 | Package Change | | 020057 | 002 | AP | 1991/09/24 | Expiration Date Change | | 020057 | 001 | AP | 1991/11/27 | Manufacturing Change or Addition | | 020057 | 000 | AP | 1991/04/05 | Approval |
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