药品名称 | RITALIN-SR | 申请号 | 018029 | 产品号 | 001 | 活性成分 | METHYLPHENIDATE HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 20MG | 治疗等效代码 | AB | 参比药物 | 否 | 批准日期 | 1982/03/30 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 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 | 018029 | 049 | AP | Letter | 2015/04/21 | 下载![](pdf.jpg) | 018029 | 049 | AP | Label | 2015/04/21 | 下载![](pdf.jpg) | 018029 | 047 | AP | Letter | 2013/12/16 | 下载![](pdf.jpg) | 018029 | 047 | AP | Label | 2013/12/17 | 下载![](pdf.jpg) | 018029 | 044 | AP | Letter | 2013/06/11 | 下载![](pdf.jpg) | 018029 | 044 | AP | Label | 2013/06/11 | 下载![](pdf.jpg) | 018029 | 043 | AP | Label | 2010/12/10 | 下载![](pdf.jpg) | 018029 | 043 | AP | Letter | 2010/12/15 | 下载![](pdf.jpg) | 018029 | 042 | AP | Label | 2010/11/17 | 下载![](pdf.jpg) | 018029 | 042 | AP | Letter | 2010/11/18 | 下载![](pdf.jpg) | 018029 | 040 | AP | Label | 2007/05/01 | 下载![](pdf.jpg) | 018029 | 040 | AP | Letter | 2007/05/01 | 下载![](pdf.jpg) | 018029 | 038 | AP | Label | 2006/08/09 | 下载![](pdf.jpg) | 018029 | 038 | AP | Letter | 2006/08/11 | 下载![](pdf.jpg) | 018029 | 037 | AP | Letter | 2006/08/11 | 下载![](pdf.jpg) | 018029 | 037 | AP | Label | 2006/08/09 | 下载![](pdf.jpg) | 018029 | 032 | AP | Letter | 2002/01/11 | 下载![](pdf.jpg) | 018029 | 029 | AP | Letter | 2004/05/27 | 下载![](pdf.jpg) | 018029 | 028 | AP | Letter | 2004/05/27 | 下载![](pdf.jpg) | 018029 | 000 | AP | Other Important Information from FDA | 2007/05/10 | 下载 | 018029 | 000 | AP | Medication Guide | 2009/11/20 | 下载![](pdf.jpg) |
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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 | 018029 | 052 | AP | 2015/12/01 | Manufacturing Change or Addition | 018029 | 049 | AP | 2015/04/17 | Labeling Revision | 018029 | 047 | AP | 2013/12/13 | Labeling Revision | 018029 | 045 | AP | 2013/10/25 | Manufacturing Change or Addition | 018029 | 044 | AP | 2013/06/07 | Labeling Revision | 018029 | 043 | AP | 2010/12/09 | Labeling Revision | 018029 | 042 | AP | 2010/11/15 | Labeling Revision | 018029 | 040 | AP | 2007/04/25 | Labeling Revision | 018029 | 038 | AP | 2006/08/08 | Labeling Revision | 018029 | 037 | AP | 2006/08/08 | Labeling Revision | 018029 | 034 | AP | 2002/06/12 | Control Supplement | 018029 | 033 | AP | 2002/05/29 | Manufacturing Change or Addition | 018029 | 032 | AP | 2002/01/11 | Labeling Revision | 018029 | 031 | AP | 2001/08/15 | Control Supplement | 018029 | 030 | AP | 2001/03/13 | Control Supplement | 018029 | 029 | AP | 2004/05/21 | Approval | 018029 | 028 | AP | 2004/05/21 | Labeling Revision | 018029 | 027 | AP | 1999/04/15 | Package Change | 018029 | 026 | AP | 1998/11/24 | Manufacturing Change or Addition | 018029 | 025 | AP | 1998/09/17 | Manufacturing Change or Addition | 018029 | 024 | AP | 1998/08/12 | Control Supplement | 018029 | 023 | AP | 1998/04/24 | Control Supplement | 018029 | 022 | AP | 1998/02/20 | Labeling Revision | 018029 | 020 | AP | 1997/07/09 | Labeling Revision | 018029 | 019 | AP | 1995/12/15 | Labeling Revision | 018029 | 018 | AP | 1997/07/09 | Labeling Revision | 018029 | 017 | AP | 1994/08/19 | Manufacturing Change or Addition | 018029 | 016 | AP | 1994/05/31 | Control Supplement | 018029 | 015 | AP | 1993/06/18 | Control Supplement | 018029 | 014 | AP | 1994/04/15 | Control Supplement | 018029 | 013 | AP | 1997/07/09 | Labeling Revision | 018029 | 012 | AP | 1994/03/09 | Control Supplement | 018029 | 011 | AP | 1990/03/09 | Manufacturing Change or Addition | 018029 | 010 | AP | 1997/07/09 | Labeling Revision | 018029 | 009 | AP | 1988/07/21 | Control Supplement | 018029 | 008 | AP | 1987/04/20 | Control Supplement | 018029 | 007 | AP | 1986/10/07 | Control Supplement | 018029 | 006 | AP | 1986/01/21 | Labeling Revision | 018029 | 005 | AP | 1985/03/13 | Expiration Date Change | 018029 | 004 | AP | 1983/09/14 | Control Supplement | 018029 | 002 | AP | 1988/10/31 | Control Supplement | 018029 | 000 | AP | 1982/03/30 | Approval |
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