药品名称 | INDERAL | 申请号 | 016418 | 产品号 | 004 | 活性成分 | PROPRANOLOL HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | WYETH PHARMACEUTICALS INC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 | 016418 | 080 | AP | Label | 2011/03/22 | 下载 | 016418 | 080 | AP | Letter | 2011/03/23 | 下载 | 016418 | 079 | AP | Letter | 2008/05/09 | 下载 | 016418 | 078 | AP | Label | 2007/09/07 | 下载 | 016418 | 078 | AP | Letter | 2007/09/07 | 下载 | 016418 | 077 | AP | Letter | 2007/03/06 | 下载 | 016418 | 076 | AP | Letter | 2007/01/08 | 下载 | 016418 | 073 | AP | Letter | 2004/08/25 | 下载 | 016418 | 073 | AP | Label | 2004/08/25 | 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 | 016418 | 080 | AP | 2011/03/17 | Labeling Revision | 016418 | 079 | AP | 2008/05/06 | Labeling Revision | 016418 | 078 | AP | 2007/09/06 | Labeling Revision | 016418 | 077 | AP | 2007/02/21 | Labeling Revision | 016418 | 076 | AP | 2006/12/29 | Labeling Revision | 016418 | 073 | AP | 2004/08/18 | Labeling Revision | 016418 | 072 | AP | 2002/02/06 | Labeling Revision | 016418 | 071 | AP | 1999/08/22 | Labeling Revision | 016418 | 070 | AP | 1997/11/07 | Labeling Revision | 016418 | 069 | AP | 1990/02/15 | Labeling Revision | 016418 | 068 | AP | 1989/03/30 | Expiration Date Change | 016418 | 067 | AP | 1988/05/25 | Package Change | 016418 | 066 | AP | 1987/01/20 | Control Supplement | 016418 | 064 | AP | 1985/10/09 | Expiration Date Change | 016418 | 063 | AP | 1985/02/28 | Package Change | 016418 | 062 | AP | 1984/12/20 | Control Supplement | 016418 | 061 | AP | 1985/02/25 | Package Change | 016418 | 058 | AP | 1984/05/21 | Formulation Revision | 016418 | 057 | AP | 1985/02/22 | Manufacturing Change or Addition | 016418 | 056 | AP | 1984/01/12 | Control Supplement | 016418 | 055 | AP | 1985/06/18 | Control Supplement | 016418 | 054 | AP | 1983/01/21 | Labeling Revision | 016418 | 053 | AP | 1983/01/07 | Control Supplement | 016418 | 052 | AP | 1982/11/12 | Formulation Revision | 016418 | 051 | AP | 1986/10/31 | New or Modified Indication | 016418 | 049 | AP | 1982/10/18 | Labeling Revision | 016418 | 048 | AP | 1982/10/18 | General Efficacy (MarkIV) | 016418 | 047 | AP | 1983/09/30 | General Efficacy (MarkIV) | 016418 | 046 | AP | 1982/02/08 | Control Supplement | 016418 | 045 | AP | 1981/10/15 | Manufacturing Change or Addition | 016418 | 044 | AP | 1986/10/31 | New or Modified Indication | 016418 | 043 | AP | 1982/01/26 | Labeling Revision | 016418 | 041 | AP | 1983/03/21 | Manufacturing Change or Addition | 016418 | 039 | AP | 1980/09/19 | Control Supplement | 016418 | 038 | AP | 1980/09/16 | Control Supplement | 016418 | 037 | AP | 1980/03/24 | Package Change | 016418 | 036 | AP | 1980/03/24 | Formulation Revision | 016418 | 035 | AP | 1986/10/31 | New or Modified Indication | 016418 | 034 | AP | 1979/03/07 | Control Supplement | 016418 | 033 | AP | 1979/03/21 | Control Supplement | 016418 | 032 | AP | 1979/05/03 | Formulation Revision | 016418 | 031 | AP | 1979/02/12 | Control Supplement | 016418 | 030 | AP | 1978/08/03 | Package Change | 016418 | 029 | AP | 1978/12/12 | Labeling Revision | 016418 | 028 | AP | 1978/02/14 | Package Change | 016418 | 027 | AP | 1978/04/24 | Control Supplement | 016418 | 026 | AP | 1978/04/24 | Package Change | 016418 | 025 | AP | 1979/01/17 | General Efficacy (MarkIV) | 016418 | 024 | AP | 1979/03/07 | Labeling Revision | 016418 | 023 | AP | 1977/12/08 | Package Change | 016418 | 022 | AP | 1977/11/03 | Control Supplement | 016418 | 021 | AP | 1976/09/21 | Control Supplement | 016418 | 020 | AP | 1978/08/21 | Labeling Revision | 016418 | 016 | AP | 1975/02/18 | Labeling Revision | 016418 | 000 | AP | 1967/11/13 | Approval |
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