药品名称 | MERIDIA | 申请号 | 020632 | 产品号 | 003 | 活性成分 | SIBUTRAMINE HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 15MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1997/11/22 | 申请机构 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
| 化学类型 | New molecular entity (NME) | 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 | 020632 | 035 | AP | Label | 2010/08/10 | 下载 | 020632 | 035 | AP | Medication Guide | 2010/08/10 | 下载 | 020632 | 035 | AP | Letter | 2010/08/10 | 下载 | 020632 | 034 | AP | Letter | 2010/08/10 | 下载 | 020632 | 034 | AP | Medication Guide | 2010/08/10 | 下载 | 020632 | 034 | AP | Label | 2010/08/10 | 下载 | 020632 | 032 | AP | Letter | 2009/05/06 | 下载 | 020632 | 032 | AP | Label | 2009/05/11 | 下载 | 020632 | 031 | AP | Letter | 2008/12/30 | 下载 | 020632 | 031 | AP | Label | 2009/01/02 | 下载 | 020632 | 030 | AP | Letter | 2008/05/30 | 下载 | 020632 | 026 | AP | Label | 2006/08/29 | 下载 | 020632 | 026 | AP | Letter | 2006/09/18 | 下载 | 020632 | 024 | AP | Letter | 2005/08/03 | 下载 | 020632 | 024 | AP | Label | 2005/08/03 | 下载 | 020632 | 021 | AP | Label | 2005/12/15 | 下载 | 020632 | 021 | AP | Letter | 2005/12/15 | 下载 | 020632 | 021 | AP | Other Important Information from FDA | 2007/07/09 | 下载 | 020632 | 020 | AP | Letter | 2004/12/02 | 下载 | 020632 | 019 | AP | Label | 2004/12/03 | 下载 | 020632 | 019 | AP | Letter | 2004/12/02 | 下载 | 020632 | 017 | AP | Letter | 2003/09/30 | 下载 | 020632 | 017 | AP | Review | 2007/07/09 | 下载 | 020632 | 015 | AP | Review | 2008/02/19 | 下载 | 020632 | 014 | AP | Review | 2008/02/19 | 下载 | 020632 | 011 | AP | Letter | 2001/02/16 | 下载 | 020632 | 011 | AP | Label | 2001/02/16 | 下载 | 020632 | 008 | AP | Letter | 2001/02/16 | 下载 | 020632 | 008 | AP | Label | 2001/02/16 | 下载 | 020632 | 006 | AP | Review | 2008/02/19 | 下载 | 020632 | 004 | AP | Review | 2008/02/19 | 下载 | 020632 | 002 | AP | Review | 2008/02/19 | 下载 | 020632 | 000 | AP | Review | 2003/06/17 | 下载 | 020632 | 000 | AP | Other | 2010/09/01 | 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 | 020632 | 035 | AP | 2010/08/04 | Labeling Revision | 020632 | 034 | AP | 2010/08/04 | Labeling Revision | 020632 | 032 | AP | 2009/05/04 | Labeling Revision | 020632 | 031 | AP | 2008/12/24 | Labeling Revision | 020632 | 030 | AP | 2008/05/29 | Labeling Revision | 020632 | 026 | AP | 2006/08/23 | Labeling Revision | 020632 | 024 | AP | 2005/07/29 | Labeling Revision | 020632 | 021 | AP | 2005/12/08 | Patient Population Altered | 020632 | 020 | AP | 2004/11/24 | Labeling Revision | 020632 | 019 | AP | 2004/11/24 | Package Change | 020632 | 017 | AP | 2003/09/25 | Labeling Revision | 020632 | 015 | AP | 2002/10/08 | Manufacturing Change or Addition | 020632 | 014 | AP | 2002/08/07 | Package Change | 020632 | 013 | AP | 2002/04/25 | Manufacturing Change or Addition | 020632 | 011 | AP | 2001/02/16 | New Dosage Regimen | 020632 | 008 | AP | 2001/02/16 | Efficacy Supplement with Clinical Data to Support | 020632 | 006 | AP | 1999/11/12 | Labeling Revision | 020632 | 004 | AP | 1999/07/06 | Package Change | 020632 | 002 | AP | 1998/08/07 | Manufacturing Change or Addition | 020632 | 001 | AP | 1998/08/07 | Manufacturing Change or Addition | 020632 | 000 | AP | 1997/11/22 | Approval |
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