药品名称 | RISPERDAL CONSTA | 申请号 | 021346 | 产品号 | 001 | 活性成分 | RISPERIDONE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INTRAMUSCULAR | 规格 | 25MG/VIAL | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2003/10/29 | 申请机构 | JANSSEN PHARMACEUTICALS INC
| 化学类型 | New dosage form | 审评分类 | |
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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 | NDF | 2006/10/29 | PED | 2007/04/29 |
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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 | 021346 | 055 | AP | Letter | 2016/03/03 | 下载 | 021346 | 055 | AP | Label | 2016/03/03 | 下载 | 021346 | 052 | AP | Label | 2014/06/10 | 下载 | 021346 | 051 | AP | Label | 2014/04/29 | 下载 | 021346 | 051 | AP | Letter | 2014/05/09 | 下载 | 021346 | 044 | AP | Letter | 2012/03/13 | 下载 | 021346 | 043 | AP | Letter | 2011/09/28 | 下载 | 021346 | 043 | AP | Label | 2011/09/30 | 下载 | 021346 | 042 | AP | Label | 2011/06/16 | 下载 | 021346 | 042 | AP | Letter | 2011/06/17 | 下载 | 021346 | 041 | AP | Letter | 2011/12/13 | 下载 | 021346 | 041 | AP | Label | 2011/12/13 | 下载 | 021346 | 040 | AP | Label | 2010/12/04 | 下载 | 021346 | 040 | AP | Letter | 2010/12/06 | 下载 | 021346 | 039 | AP | Letter | 2010/09/01 | 下载 | 021346 | 039 | AP | Label | 2010/08/30 | 下载 | 021346 | 038 | AP | Label | 2010/08/30 | 下载 | 021346 | 038 | AP | Letter | 2010/09/01 | 下载 | 021346 | 037 | AP | Label | 2011/09/30 | 下载 | 021346 | 037 | AP | Letter | 2011/09/28 | 下载 | 021346 | 036 | AP | Letter | 2011/08/26 | 下载 | 021346 | 036 | AP | Label | 2011/09/02 | 下载 | 021346 | 035 | AP | Letter | 2010/09/01 | 下载 | 021346 | 035 | AP | Label | 2010/08/30 | 下载 | 021346 | 033 | AP | Label | 2009/08/06 | 下载 | 021346 | 033 | AP | Letter | 2009/08/06 | 下载 | 021346 | 032 | AP | Letter | 2011/12/13 | 下载 | 021346 | 032 | AP | Label | 2011/12/13 | 下载 | 021346 | 031 | AP | Label | 2010/08/30 | 下载 | 021346 | 031 | AP | Letter | 2010/09/01 | 下载 | 021346 | 028 | AP | Letter | 2009/05/20 | 下载 | 021346 | 028 | AP | Label | 2009/06/07 | 下载 | 021346 | 027 | AP | Letter | 2008/08/19 | 下载 | 021346 | 026 | AP | Letter | 2008/10/14 | 下载 | 021346 | 026 | AP | Label | 2008/11/07 | 下载 | 021346 | 025 | AP | Letter | 2009/05/20 | 下载 | 021346 | 025 | AP | Label | 2009/06/07 | 下载 | 021346 | 023 | AP | Label | 2008/11/07 | 下载 | 021346 | 023 | AP | Letter | 2008/10/14 | 下载 | 021346 | 022 | AP | Label | 2008/11/07 | 下载 | 021346 | 022 | AP | Letter | 2008/10/14 | 下载 | 021346 | 021 | AP | Label | 2008/11/07 | 下载 | 021346 | 021 | AP | Letter | 2008/10/14 | 下载 | 021346 | 020 | AP | Letter | 2007/03/15 | 下载 | 021346 | 020 | AP | Label | 2007/03/15 | 下载 | 021346 | 015 | AP | Letter | 2007/04/20 | 下载 | 021346 | 015 | AP | Label | 2007/04/20 | 下载 | 021346 | 013 | AP | Label | 2006/09/21 | 下载 | 021346 | 013 | AP | Letter | 2006/09/25 | 下载 | 021346 | 011 | AP | Letter | 2006/08/04 | 下载 | 021346 | 010 | AP | Letter | 2005/08/19 | 下载 | 021346 | 010 | AP | Label | 2005/08/19 | 下载 | 021346 | 009 | AP | Letter | 2006/10/23 | 下载 | 021346 | 000 | AP | Letter | 2003/11/28 | 下载 | 021346 | 000 | AP | Review | 2005/06/16 | 下载 | 021346 | 000 | AP | Other Important Information from FDA | 2011/12/20 | 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 | 021346 | 055 | AP | 2016/03/01 | Labeling Revision | 021346 | 052 | AP | 2014/06/05 | Manufacturing Change or Addition | 021346 | 051 | AP | 2014/04/28 | Labeling Revision | 021346 | 050 | AP | 2013/10/22 | Manufacturing Change or Addition | 021346 | 049 | AP | 2013/07/18 | Manufacturing Change or Addition | 021346 | 048 | AP | 2013/02/26 | Manufacturing Change or Addition | 021346 | 047 | AP | 2013/10/10 | Manufacturing Change or Addition | 021346 | 044 | AP | 2012/03/12 | Labeling Revision | 021346 | 043 | AP | 2011/09/24 | Labeling Revision | 021346 | 042 | AP | 2011/06/15 | Labeling Revision | 021346 | 041 | AP | 2011/12/07 | Labeling Revision | 021346 | 040 | AP | 2010/12/01 | Labeling Revision | 021346 | 039 | AP | 2010/08/30 | Labeling Revision | 021346 | 038 | AP | 2010/08/30 | Labeling Revision | 021346 | 037 | AP | 2011/09/24 | Labeling Revision | 021346 | 036 | AP | 2011/08/24 | Labeling Revision | 021346 | 035 | AP | 2010/08/30 | Labeling Revision | 021346 | 033 | AP | 2009/07/19 | Labeling Revision | 021346 | 032 | AP | 2011/12/07 | Labeling Revision | 021346 | 031 | AP | 2010/08/30 | Labeling Revision | 021346 | 028 | AP | 2009/05/15 | New or Modified Indication | 021346 | 027 | AP | 2008/08/14 | Labeling Revision | 021346 | 026 | AP | 2008/10/08 | Labeling Revision | 021346 | 025 | AP | 2009/05/15 | New or Modified Indication | 021346 | 023 | AP | 2008/10/08 | Labeling Revision | 021346 | 022 | AP | 2008/10/08 | Labeling Revision | 021346 | 021 | AP | 2008/10/08 | Labeling Revision | 021346 | 020 | AP | 2007/03/09 | Labeling Revision | 021346 | 015 | AP | 2007/04/12 | New Dosage Regimen | 021346 | 013 | AP | 2006/09/20 | Labeling Revision | 021346 | 011 | AP | 2006/07/31 | Labeling Revision | 021346 | 010 | AP | 2005/08/17 | Labeling Revision | 021346 | 009 | AP | 2006/10/20 | Labeling Revision | 021346 | 000 | AP | 2003/10/29 | Approval |
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