| 药品名称 | CORTISPORIN | | 申请号 | 050169 | 产品号 | 001 | | 活性成分 | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 市场状态 | 停止上市 | | 剂型或给药途径 | SUSPENSION/DROPS;OPHTHALMIC | 规格 | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | | 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 | MONARCH PHARMACEUTICALS INC
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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 | | 050169 | 046 | AP | Letter | 2003/12/02 | 下载 | | 050169 | 046 | AP | Label | 2003/12/02 | 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 | | 050169 | 046 | AP | 2003/11/25 | Labeling Revision | | 050169 | 045 | AP | 1999/04/19 | Manufacturing Change or Addition | | 050169 | 044 | AP | 1995/06/13 | Control Supplement | | 050169 | 042 | AP | 1982/09/13 | Control Supplement | | 050169 | 041 | AP | 1982/03/26 | Manufacturing Change or Addition | | 050169 | 040 | AP | 1982/01/26 | Control Supplement | | 050169 | 037 | AP | 1981/10/20 | Manufacturing Change or Addition | | 050169 | 036 | AP | 1981/09/15 | Control Supplement | | 050169 | 035 | AP | 1980/12/01 | Labeling Revision | | 050169 | 034 | AP | 1981/01/16 | New or Modified Indication | | 050169 | 031 | AP | 1972/11/20 | Labeling Revision | | 050169 | 030 | AP | 1972/07/06 | Labeling Revision | | 050169 | 028 | AP | 1972/06/21 | Labeling Revision | | 050169 | 025 | AP | 1971/05/11 | Control Supplement | | 050169 | 024 | AP | 1970/12/18 | Labeling Revision | | 050169 | 023 | AP | 1970/10/09 | Labeling Revision | | 050169 | 022 | AP | 1970/07/27 | Labeling Revision | | 050169 | 020 | AP | 1969/03/17 | Package Change | | 050169 | 019 | AP | 1969/03/25 | Control Supplement | | 050169 | 017 | AP | 1969/03/24 | Control Supplement | | 050169 | 016 | AP | 1967/07/13 | Labeling Revision | | 050169 | 015 | AP | 1967/04/20 | Labeling Revision | | 050169 | 014 | AP | 1967/04/10 | Labeling Revision | | 050169 | 013 | AP | 1967/04/04 | Labeling Revision | | 050169 | 012 | AP | 1966/10/19 | Labeling Revision | | 050169 | 010 | AP | 1966/09/13 | Labeling Revision | | 050169 | 009 | AP | 1994/05/10 | Labeling Revision | | 050169 | 008 | AP | 1985/12/13 | Control Supplement | | 050169 | 007 | AP | 1984/08/21 | Package Change | | 050169 | 006 | AP | 1984/02/28 | Package Change | | 050169 | 003 | AP | 1966/05/05 | Labeling Revision | | 050169 | 002 | AP | 1965/09/30 | Labeling Revision | | 050169 | 001 | AP | 1983/03/30 | Labeling Revision | | 050169 | 000 | AP | 1964/12/18 | Approval |
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