药品名称 | ADDERALL 10 | 申请号 | 011522 | 产品号 | 007 | 活性成分 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1996/02/13 | 申请机构 | TEVA WOMENS HEALTH INC
| 化学类型 | | 审评分类 | Standard review drug |
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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 | 011522 | 042 | AP | Letter | 2015/10/06 | 下载![](pdf.jpg) | 011522 | 042 | AP | Label | 2015/10/07 | 下载![](pdf.jpg) | 011522 | 042 | AP | Medication Guide | 2015/10/23 | 下载![](pdf.jpg) | 011522 | 041 | AP | Label | 2015/04/19 | 下载![](pdf.jpg) | 011522 | 041 | AP | Letter | 2015/04/20 | 下载![](pdf.jpg) | 011522 | 040 | AP | Label | 2007/06/12 | 下载![](pdf.jpg) | 011522 | 040 | AP | Letter | 2007/06/14 | 下载![](pdf.jpg) | 011522 | 037 | AP | Letter | 2006/07/27 | 下载![](pdf.jpg) | 011522 | 037 | AP | Label | 2006/07/27 | 下载![](pdf.jpg) | 011522 | 034 | AP | Letter | 2006/07/27 | 下载![](pdf.jpg) | 011522 | 034 | AP | Label | 2006/07/27 | 下载![](pdf.jpg) | 011522 | 033 | AP | Label | 2005/08/04 | 下载![](pdf.jpg) | 011522 | 033 | AP | Letter | 2005/08/04 | 下载![](pdf.jpg) | 011522 | 032 | AP | Letter | 2005/08/04 | 下载![](pdf.jpg) | 011522 | 032 | AP | Label | 2005/08/04 | 下载![](pdf.jpg) | 011522 | 030 | AP | Review | 2004/04/14 | 下载 | 011522 | 030 | AP | Letter | 2002/11/08 | 下载![](pdf.jpg) | 011522 | 010 | AP | Review | 2000/06/12 | 下载![](pdf.jpg) | 011522 | 000 | AP | Other Important Information from FDA | 2007/05/31 | 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 | 011522 | 042 | AP | 2015/10/01 | Labeling Revision | 011522 | 041 | AP | 2015/04/17 | Labeling Revision | 011522 | 040 | AP | 2007/06/07 | Labeling Revision | 011522 | 037 | AP | 2006/07/26 | Labeling Revision | 011522 | 034 | AP | 2006/07/26 | Labeling Revision | 011522 | 033 | AP | 2005/08/02 | Labeling Revision | 011522 | 032 | AP | 2005/08/02 | Labeling Revision | 011522 | 030 | AP | 2002/11/08 | Formulation Revision | 011522 | 029 | AP | 2002/04/11 | Manufacturing Change or Addition | 011522 | 028 | AP | 2001/12/10 | Control Supplement | 011522 | 027 | AP | 2000/07/24 | Control Supplement | 011522 | 026 | AP | 2000/08/31 | Manufacturing Change or Addition | 011522 | 025 | AP | 2000/02/15 | Manufacturing Change or Addition | 011522 | 024 | AP | 2000/01/26 | Manufacturing Change or Addition | 011522 | 023 | AP | 1999/09/20 | Control Supplement | 011522 | 022 | AP | 1999/11/12 | Control Supplement | 011522 | 021 | AP | 1999/05/21 | Manufacturing Change or Addition | 011522 | 020 | AP | 1999/02/23 | Manufacturing Change or Addition | 011522 | 019 | AP | 1998/03/16 | Control Supplement | 011522 | 018 | AP | 1998/01/08 | Control Supplement | 011522 | 017 | AP | 1997/07/25 | Labeling Revision | 011522 | 016 | AP | 1997/11/14 | Control Supplement | 011522 | 015 | AP | 1997/07/17 | Labeling Revision | 011522 | 014 | AP | 1997/06/13 | Control Supplement | 011522 | 013 | AP | 1997/05/12 | Manufacturing Change or Addition | 011522 | 012 | AP | 1997/01/29 | Control Supplement | 011522 | 011 | AP | 1997/07/17 | Labeling Revision | 011522 | 010 | AP | 1996/02/13 | Formulation Revision | 011522 | 009 | AP | 1996/02/13 | Labeling Revision | 011522 | 000 | AP | 1960/01/19 | Approval |
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