药品名称 | LITHOBID | 申请号 | 018027 | 产品号 | 001 | 活性成分 | LITHIUM CARBONATE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 300MG | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ANI PHARMACEUTICALS INC
| 化学类型 | New formulation or new manufacturer | 审评分类 | Standard 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 | 018027 | 059 | AP | Letter | 2016/06/01 | 下载 | 018027 | 059 | AP | Label | 2016/06/01 | 下载 | 018027 | 056 | AP | Letter | 2011/10/24 | 下载 | 018027 | 056 | AP | Label | 2011/10/25 | 下载 | 018027 | 055 | AP | Letter | 2006/10/05 | 下载 | 018027 | 055 | AP | Review | 2008/04/02 | 下载 | 018027 | 051 | AP | Letter | 2006/04/13 | 下载 | 018027 | 049 | AP | Label | 2002/10/07 | 下载 | 018027 | 049 | AP | Letter | 2002/10/07 | 下载 | 018027 | 046 | AP | Letter | 2002/10/07 | 下载 | 018027 | 046 | AP | Label | 2002/10/07 | 下载 | 018027 | 040 | AP | Letter | 2002/10/07 | 下载 | 018027 | 040 | AP | Label | 2002/10/07 | 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 | 018027 | 059 | AP | 2016/05/27 | Labeling Revision | 018027 | 058 | AP | 2015/05/11 | Manufacturing Change or Addition | 018027 | 057 | AP | 2015/01/05 | Manufacturing Change or Addition | 018027 | 056 | AP | 2011/10/20 | Labeling Revision | 018027 | 055 | AP | 2006/10/01 | Labeling Revision | 018027 | 051 | AP | 2006/04/07 | Labeling Revision | 018027 | 049 | AP | 2002/10/07 | Labeling Revision | 018027 | 048 | AP | 2001/10/16 | Expiration Date Change | 018027 | 047 | AP | 2000/12/22 | Expiration Date Change | 018027 | 046 | AP | 2002/10/07 | Labeling Revision | 018027 | 045 | AP | 1997/07/11 | Manufacturing Change or Addition | 018027 | 043 | AP | 1995/05/26 | Control Supplement | 018027 | 040 | AP | 2002/10/07 | Labeling Revision | 018027 | 037 | AP | 1990/05/02 | Formulation Revision | 018027 | 035 | AP | 2002/10/07 | Labeling Revision | 018027 | 034 | AP | 1990/04/20 | Labeling Revision | 018027 | 032 | AP | 1988/10/13 | Package Change | 018027 | 031 | AP | 1988/10/13 | Package Change | 018027 | 029 | AP | 1988/08/24 | Manufacturing Change or Addition | 018027 | 028 | AP | 1989/04/07 | Package Change | 018027 | 027 | AP | 2002/10/07 | Labeling Revision | 018027 | 025 | AP | 2002/10/07 | Labeling Revision | 018027 | 024 | AP | 1986/05/01 | Control Supplement | 018027 | 022 | AP | 1985/03/26 | Manufacturing Change or Addition | 018027 | 021 | AP | 1985/05/29 | Control Supplement | 018027 | 020 | AP | 1983/02/25 | Package Change | 018027 | 019 | AP | 1983/02/25 | Package Change | 018027 | 018 | AP | 1982/04/19 | Manufacturing Change or Addition | 018027 | 017 | AP | 1982/02/19 | Package Change | 018027 | 016 | AP | 1981/09/25 | Labeling Revision | 018027 | 015 | AP | 1981/08/06 | Package Change | 018027 | 013 | AP | 1981/04/06 | Manufacturing Change or Addition | 018027 | 010 | AP | 1980/10/02 | Labeling Revision | 018027 | 009 | AP | 1980/05/13 | Manufacturing Change or Addition | 018027 | 008 | AP | 1984/03/26 | Manufacturing Change or Addition | 018027 | 005 | AP | 1979/10/03 | Package Change | 018027 | 004 | AP | 1979/10/03 | Labeling Revision | 018027 | 003 | AP | 1980/01/04 | Labeling Revision | 018027 | 002 | AP | 1979/10/03 | Package Change | 018027 | 001 | AP | 1979/09/13 | Labeling Revision | 018027 | 000 | AP | 1979/04/27 | Approval |
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