药品名称 | ACCUTANE | 申请号 | 018662 | 产品号 | 004 | 活性成分 | ISOTRETINOIN | 市场状态 | 停止上市 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 20MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1983/03/28 | 申请机构 | HOFFMANN LA ROCHE INC
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | 018662 | 061 | AP | Medication Guide | 2010/10/25 | 下载 | 018662 | 061 | AP | Letter | 2010/10/26 | 下载 | 018662 | 060 | AP | Label | 2010/02/04 | 下载 | 018662 | 060 | AP | Letter | 2010/02/05 | 下载 | 018662 | 059 | AP | Letter | 2008/11/21 | 下载 | 018662 | 059 | AP | Label | 2009/06/10 | 下载 | 018662 | 058 | AP | Letter | 2007/10/10 | 下载 | 018662 | 058 | AP | Label | 2007/10/10 | 下载 | 018662 | 057 | AP | Review | 2007/07/06 | 下载 | 018662 | 056 | AP | Label | 2005/08/12 | 下载 | 018662 | 056 | AP | Letter | 2005/08/15 | 下载 | 018662 | 056 | AP | Review | 2007/07/06 | 下载 | 018662 | 055 | AP | Review | 2007/07/06 | 下载 | 018662 | 054 | AP | Letter | 2004/08/25 | 下载 | 018662 | 054 | AP | Label | 2004/08/25 | 下载 | 018662 | 054 | AP | Review | 2007/07/06 | 下载 | 018662 | 053 | AP | Review | 2007/07/06 | 下载 | 018662 | 052 | AP | Review | 2007/07/06 | 下载 | 018662 | 052 | AP | Label | 2003/08/29 | 下载 | 018662 | 052 | AP | Letter | 2004/05/25 | 下载 | 018662 | 051 | AP | Letter | 2002/06/20 | 下载 | 018662 | 051 | AP | Label | 2002/06/20 | 下载 | 018662 | 048 | AP | Letter | 2003/08/27 | 下载 | 018662 | 048 | AP | Label | 2003/08/29 | 下载 | 018662 | 048 | AP | Review | 2007/07/06 | 下载 | 018662 | 047 | AP | Letter | 2002/04/12 | 下载 | 018662 | 047 | AP | Patient Package Insert | 2002/04/12 | 下载 | 018662 | 046 | AP | Letter | 2002/02/15 | 下载 | 018662 | 046 | AP | Label | 2002/02/15 | 下载 | 018662 | 045 | AP | Letter | 2001/12/31 | 下载 | 018662 | 045 | AP | Label | 2001/12/31 | 下载 | 018662 | 044 | AP | Letter | 2001/10/30 | 下载 | 018662 | 044 | AP | Label | 2001/10/30 | 下载 | 018662 | 043 | AP | Letter | 2002/05/02 | 下载 | 018662 | 043 | AP | Label | 2002/05/02 | 下载 | 018662 | 042 | AP | Review | 2007/07/06 | 下载 | 018662 | 041 | AP | Letter | 2001/12/31 | 下载 | 018662 | 041 | AP | Label | 2001/12/31 | 下载 | 018662 | 040 | AP | Letter | 2000/05/01 | 下载 | 018662 | 039 | AP | Letter | 2000/05/01 | 下载 | 018662 | 038 | AP | Letter | 2000/05/01 | 下载 | 018662 | 038 | AP | Review | 2007/07/06 | 下载 | 018662 | 000 | AP | Other Important Information from FDA | 2005/07/28 | 下载 | 018662 | 000 | AP | Medication Guide | 2010/02/17 | 下载 | 018662 | 000 | AP | Other | 2015/07/02 | 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 | 018662 | 061 | AP | 2010/10/22 | Labeling Revision | 018662 | 060 | AP | 2010/02/01 | Labeling Revision | 018662 | 059 | AP | 2008/11/19 | Labeling Revision | 018662 | 058 | AP | 2007/10/03 | Labeling Revision | 018662 | 057 | AP | 2006/01/13 | Supplement | 018662 | 056 | AP | 2005/08/12 | Labeling Revision | 018662 | 055 | AP | 2005/08/10 | Supplement | 018662 | 054 | AP | 2004/08/24 | Labeling Revision | 018662 | 053 | AP | 2004/03/26 | Manufacturing Change or Addition | 018662 | 052 | AP | 2003/08/27 | Labeling Revision | 018662 | 051 | AP | 2002/06/20 | Labeling Revision | 018662 | 048 | AP | 2003/08/27 | Labeling Revision | 018662 | 047 | AP | 2002/04/12 | Labeling Revision | 018662 | 046 | AP | 2002/02/15 | Labeling Revision | 018662 | 045 | AP | 2001/12/31 | Labeling Revision | 018662 | 044 | AP | 2001/10/30 | Labeling Revision | 018662 | 043 | AP | 2002/05/02 | Efficacy Supplement with Clinical Data to Support | 018662 | 042 | AP | 2001/01/11 | Control Supplement | 018662 | 041 | AP | 2001/12/31 | Labeling Revision | 018662 | 040 | AP | 2000/05/01 | Labeling Revision | 018662 | 039 | AP | 2000/05/01 | Labeling Revision | 018662 | 038 | AP | 2000/05/01 | Labeling Revision | 018662 | 037 | AP | 1999/04/30 | Package Change | 018662 | 034 | AP | 1995/05/17 | Labeling Revision | 018662 | 033 | AP | 1994/01/13 | Labeling Revision | 018662 | 032 | AP | 1991/10/08 | Control Supplement | 018662 | 031 | AP | 1990/10/16 | Package Change | 018662 | 030 | AP | 1991/03/07 | Labeling Revision | 018662 | 029 | AP | 1990/04/16 | Labeling Revision | 018662 | 028 | AP | 1989/08/09 | Package Change | 018662 | 027 | AP | 1989/04/04 | Manufacturing Change or Addition | 018662 | 026 | AP | 1989/04/28 | Package Change | 018662 | 025 | AP | 1988/11/16 | Package Change | 018662 | 024 | AP | 1988/08/26 | Labeling Revision | 018662 | 023 | AP | 1988/01/07 | Expiration Date Change | 018662 | 022 | AP | 1987/10/19 | Labeling Revision | 018662 | 021 | AP | 1987/06/03 | Control Supplement | 018662 | 020 | AP | 1987/06/01 | Labeling Revision | 018662 | 019 | AP | 1987/02/26 | Package Change | 018662 | 018 | AP | 1986/06/06 | Labeling Revision | 018662 | 017 | AP | 1986/06/06 | Labeling Revision | 018662 | 016 | AP | 1985/07/05 | Labeling Revision | 018662 | 015 | AP | 1985/04/30 | Labeling Revision | 018662 | 014 | AP | 1986/06/06 | New Dosage Regimen | 018662 | 013 | AP | 1984/11/27 | Control Supplement | 018662 | 011 | AP | 1984/11/01 | Manufacturing Change or Addition | 018662 | 010 | AP | 1986/06/06 | Labeling Revision | 018662 | 009 | AP | 1984/05/31 | Package Change | 018662 | 008 | AP | 1984/02/28 | Labeling Revision | 018662 | 007 | AP | 1985/06/19 | Control Supplement | 018662 | 004 | AP | 1983/08/09 | Labeling Revision | 018662 | 003 | AP | 1986/06/06 | Labeling Revision | 018662 | 002 | AP | 1983/06/30 | Manufacturing Change or Addition | 018662 | 001 | AP | 1986/06/06 | Labeling Revision | 018662 | 000 | AP | 1982/05/07 | Approval |
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