药品名称 | INFED | 申请号 | 017441 | 产品号 | 001 | 活性成分 | IRON DEXTRAN | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 50MG IRON/ML | 治疗等效代码 | BP | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ALLERGAN SALES LLC
| 化学类型 | New formulation or new manufacturer | 审评分类 | Priority review drug |
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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 | 017441 | 171 | AP | Label | 2009/09/17 | 下载 | 017441 | 161 | AP | Letter | 2001/04/18 | 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 | 017441 | 171 | AP | 2009/08/12 | Labeling Revision | 017441 | 164 | AP | 2002/11/26 | Control Supplement | 017441 | 162 | AP | 2001/11/20 | Control Supplement | 017441 | 161 | AP | 2001/04/18 | Labeling Revision | 017441 | 160 | AP | 2001/07/24 | Control Supplement | 017441 | 159 | AP | 2001/07/23 | Control Supplement | 017441 | 158 | AP | 1999/09/13 | Manufacturing Change or Addition | 017441 | 157 | AP | 1999/04/15 | Control Supplement | 017441 | 155 | AP | 1999/01/13 | Manufacturing Change or Addition | 017441 | 154 | AP | 1999/01/13 | Control Supplement | 017441 | 153 | AP | 1998/05/22 | Control Supplement | 017441 | 152 | AP | 1997/02/21 | Control Supplement | 017441 | 151 | AP | 1997/04/04 | Labeling Revision | 017441 | 150 | AP | 1997/04/04 | Labeling Revision | 017441 | 149 | AP | 1995/08/11 | Manufacturing Change or Addition | 017441 | 148 | AP | 1994/04/13 | Labeling Revision | 017441 | 146 | AP | 1994/04/12 | Package Change | 017441 | 145 | AP | 1992/04/22 | Manufacturing Change or Addition | 017441 | 144 | AP | 1991/08/05 | Labeling Revision | 017441 | 143 | AP | 1991/07/12 | Labeling Revision | 017441 | 142 | AP | 1991/07/12 | Control Supplement | 017441 | 141 | AP | 1991/07/12 | Manufacturing Change or Addition | 017441 | 139 | AP | 1988/01/12 | Labeling Revision | 017441 | 138 | AP | 1986/04/07 | Manufacturing Change or Addition | 017441 | 137 | AP | 1985/05/13 | Labeling Revision | 017441 | 135 | AP | 1981/06/17 | Distributor | 017441 | 134 | AP | 1981/06/15 | Distributor | 017441 | 133 | AP | 1981/06/15 | Distributor | 017441 | 132 | AP | 1981/06/15 | Distributor | 017441 | 131 | AP | 1981/02/18 | Distributor | 017441 | 130 | AP | 1981/03/05 | Distributor | 017441 | 129 | AP | 1981/03/05 | Distributor | 017441 | 128 | AP | 1981/02/03 | Distributor | 017441 | 127 | AP | 1981/01/16 | Distributor | 017441 | 126 | AP | 1980/08/20 | Distributor | 017441 | 125 | AP | 1980/08/20 | Distributor | 017441 | 121 | AP | 1980/07/07 | Distributor | 017441 | 120 | AP | 1980/04/01 | Distributor | 017441 | 119 | AP | 1980/01/21 | Labeling Revision | 017441 | 118 | AP | 1980/01/21 | Distributor | 017441 | 117 | AP | 1980/01/21 | Distributor | 017441 | 116 | AP | 1980/01/21 | Distributor | 017441 | 115 | AP | 1980/01/21 | Distributor | 017441 | 114 | AP | 1980/01/21 | Distributor | 017441 | 113 | AP | 1980/01/21 | Distributor | 017441 | 111 | AP | 1979/08/13 | Distributor | 017441 | 110 | AP | 1979/08/13 | Distributor | 017441 | 109 | AP | 1979/08/13 | Distributor | 017441 | 108 | AP | 1979/08/13 | Distributor | 017441 | 107 | AP | 1979/08/13 | Labeling Revision | 017441 | 106 | AP | 1979/08/13 | Distributor | 017441 | 105 | AP | 1979/08/13 | Distributor | 017441 | 104 | AP | 1978/08/07 | Distributor | 017441 | 103 | AP | 1978/07/31 | Control Supplement | 017441 | 102 | AP | 1978/07/31 | Control Supplement | 017441 | 101 | AP | 1978/07/31 | Control Supplement | 017441 | 100 | AP | 1978/07/31 | Control Supplement | 017441 | 099 | AP | 1978/07/31 | Control Supplement | 017441 | 098 | AP | 1978/07/31 | Control Supplement | 017441 | 097 | AP | 1978/07/31 | Control Supplement | 017441 | 096 | AP | 1978/07/31 | Control Supplement | 017441 | 095 | AP | 1978/07/31 | Control Supplement | 017441 | 094 | AP | 1978/07/31 | Control Supplement | 017441 | 093 | AP | 1978/07/31 | Control Supplement | 017441 | 092 | AP | 1978/07/31 | Control Supplement | 017441 | 091 | AP | 1978/07/31 | Control Supplement | 017441 | 090 | AP | 1978/07/31 | Control Supplement | 017441 | 089 | AP | 1978/07/31 | Control Supplement | 017441 | 088 | AP | 1978/07/31 | Control Supplement | 017441 | 087 | AP | 1978/07/31 | Control Supplement | 017441 | 086 | AP | 1978/07/31 | Control Supplement | 017441 | 085 | AP | 1978/07/31 | Control Supplement | 017441 | 084 | AP | 1978/07/31 | Control Supplement | 017441 | 083 | AP | 1978/07/31 | Control Supplement | 017441 | 082 | AP | 1978/07/31 | Control Supplement | 017441 | 081 | AP | 1978/07/31 | Control Supplement | 017441 | 080 | AP | 1978/07/31 | Control Supplement | 017441 | 079 | AP | 1978/07/31 | Control Supplement | 017441 | 078 | AP | 1978/07/31 | Control Supplement | 017441 | 077 | AP | 1978/07/31 | Control Supplement | 017441 | 076 | AP | 1978/07/31 | Control Supplement | 017441 | 075 | AP | 1978/07/31 | Control Supplement | 017441 | 074 | AP | 1978/07/31 | Control Supplement | 017441 | 073 | AP | 1978/07/31 | Control Supplement | 017441 | 072 | AP | 1978/07/31 | Control Supplement | 017441 | 071 | AP | 1978/07/31 | Control Supplement | 017441 | 070 | AP | 1978/07/31 | Control Supplement | 017441 | 069 | AP | 1978/07/31 | Control Supplement | 017441 | 068 | AP | 1978/07/31 | Control Supplement | 017441 | 067 | AP | 1978/07/31 | Control Supplement | 017441 | 066 | AP | 1978/07/31 | Control Supplement | 017441 | 065 | AP | 1978/07/31 | Control Supplement | 017441 | 064 | AP | 1978/07/31 | Control Supplement | 017441 | 063 | AP | 1978/07/31 | Control Supplement | 017441 | 062 | AP | 1978/07/31 | Control Supplement | 017441 | 061 | AP | 1978/07/31 | Control Supplement | 017441 | 060 | AP | 1978/07/31 | Distributor | 017441 | 059 | AP | 1978/07/31 | Distributor | 017441 | 058 | AP | 1978/07/31 | Distributor | 017441 | 057 | AP | 1978/07/31 | Distributor | 017441 | 056 | AP | 1978/07/31 | Labeling Revision | 017441 | 054 | AP | 1976/10/04 | Distributor | 017441 | 053 | AP | 1976/10/04 | Distributor | 017441 | 052 | AP | 1976/10/04 | Distributor | 017441 | 051 | AP | 1976/10/04 | Distributor | 017441 | 050 | AP | 1976/10/04 | Distributor | 017441 | 048 | AP | 1976/10/04 | Distributor | 017441 | 047 | AP | 1976/10/04 | Distributor | 017441 | 046 | AP | 1976/10/04 | Distributor | 017441 | 045 | AP | 1976/01/22 | Control Supplement | 017441 | 043 | AP | 1976/10/04 | Labeling Revision | 017441 | 042 | AP | 1976/10/04 | Labeling Revision | 017441 | 041 | AP | 1976/10/04 | Labeling Revision | 017441 | 040 | AP | 1976/10/04 | Labeling Revision | 017441 | 039 | AP | 1976/10/04 | Labeling Revision | 017441 | 038 | AP | 1976/10/04 | Labeling Revision | 017441 | 037 | AP | 1976/10/04 | Labeling Revision | 017441 | 036 | AP | 1976/10/04 | Labeling Revision | 017441 | 035 | AP | 1976/10/04 | Labeling Revision | 017441 | 034 | AP | 1976/10/04 | Labeling Revision | 017441 | 033 | AP | 1976/10/04 | Labeling Revision | 017441 | 032 | AP | 1976/10/04 | Labeling Revision | 017441 | 031 | AP | 1976/10/04 | Labeling Revision | 017441 | 030 | AP | 1976/10/04 | Labeling Revision | 017441 | 029 | AP | 1976/10/04 | Labeling Revision | 017441 | 028 | AP | 1976/10/04 | Labeling Revision | 017441 | 027 | AP | 1978/07/31 | Labeling Revision | 017441 | 026 | AP | 1976/10/04 | Labeling Revision | 017441 | 025 | AP | 1976/10/04 | Labeling Revision | 017441 | 023 | AP | 1976/10/04 | Labeling Revision | 017441 | 022 | AP | 1976/10/04 | Labeling Revision | 017441 | 021 | AP | 1976/10/04 | Labeling Revision | 017441 | 020 | AP | 1976/10/04 | Labeling Revision | 017441 | 019 | AP | 1976/10/04 | Labeling Revision | 017441 | 018 | AP | 1976/10/04 | Labeling Revision | 017441 | 017 | AP | 1976/10/04 | Labeling Revision | 017441 | 016 | AP | 1976/10/04 | Labeling Revision | 017441 | 015 | AP | 1976/10/04 | Labeling Revision | 017441 | 013 | AP | 1975/03/26 | Distributor | 017441 | 012 | AP | 1975/03/26 | Distributor | 017441 | 011 | AP | 1975/03/26 | Distributor | 017441 | 000 | AP | 1974/04/29 | Approval |
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