药品名称 | BLENOXANE | 申请号 | 050443 | 产品号 | 001 | 活性成分 | BLEOMYCIN SULFATE | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| 化学类型 | New molecular entity (NME) | 审评分类 | |
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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 | 050443 | 036 | AP | Label | 2010/05/11 | 下载 | 050443 | 036 | AP | Letter | 2010/05/17 | 下载 | 050443 | 035 | AP | Label | 2003/03/26 | 下载 | 050443 | 035 | AP | Letter | 2003/03/26 | 下载 | 050443 | 027 | AP | Letter | 2004/07/01 | 下载 | 050443 | 026 | AP | Review | 1999/08/02 | 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 | 050443 | 036 | AP | 2010/05/10 | Labeling Revision | 050443 | 035 | AP | 2003/03/21 | Labeling Revision | 050443 | 033 | AP | 2002/03/20 | Manufacturing Change or Addition | 050443 | 032 | AP | 2000/07/03 | Manufacturing Change or Addition | 050443 | 031 | AP | 2000/04/12 | Package Change | 050443 | 030 | AP | 2000/07/03 | Manufacturing Change or Addition | 050443 | 029 | AP | 1999/10/20 | Labeling Revision | 050443 | 028 | AP | 1999/08/25 | Labeling Revision | 050443 | 027 | AP | 2004/06/30 | Labeling Revision | 050443 | 026 | AP | 1996/09/30 | Manufacturing Change or Addition | 050443 | 025 | AP | 1996/02/20 | New or Modified Indication | 050443 | 024 | AP | 1995/09/07 | Manufacturing Change or Addition | 050443 | 023 | AP | 1993/02/23 | Labeling Revision | 050443 | 022 | AP | 1994/01/21 | Control Supplement | 050443 | 021 | AP | 1994/01/21 | Manufacturing Change or Addition | 050443 | 020 | AP | 1991/01/30 | Control Supplement | 050443 | 019 | AP | 1994/01/21 | Control Supplement | 050443 | 017 | AP | 1994/01/21 | Control Supplement | 050443 | 014 | AP | 1983/10/21 | Control Supplement | 050443 | 013 | AP | 1983/10/19 | Expiration Date Change | 050443 | 012 | AP | 1983/09/26 | Control Supplement | 050443 | 011 | AP | 1983/04/13 | Labeling Revision | 050443 | 010 | AP | 1982/12/13 | Control Supplement | 050443 | 009 | AP | 1976/12/21 | Labeling Revision | 050443 | 008 | AP | 1976/03/15 | Labeling Revision | 050443 | 007 | AP | 1976/03/31 | Control Supplement | 050443 | 006 | AP | 1975/10/10 | Control Supplement | 050443 | 005 | AP | 1976/04/05 | Expiration Date Change | 050443 | 004 | AP | 1975/10/08 | Labeling Revision | 050443 | 003 | AP | 1975/03/05 | Control Supplement | 050443 | 002 | AP | 1974/08/09 | Labeling Revision | 050443 | 000 | AP | 1973/07/31 | Approval |
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