| 药品名称 | TESSALON | | 申请号 | 011210 | 产品号 | 003 | | 活性成分 | BENZONATATE | 市场状态 | 停止上市 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1999/06/25 | 申请机构 | PFIZER INC
| | 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 | | 011210 | 053 | AP | Label | 2011/01/25 | 下载 | | 011210 | 053 | AP | Letter | 2011/01/25 | 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 | | 011210 | 053 | AP | 2011/01/20 | Labeling Revision | | 011210 | 041 | AP | 2002/07/23 | Manufacturing Change or Addition | | 011210 | 040 | AP | 2000/11/01 | Control Supplement | | 011210 | 039 | AP | 2000/06/30 | Control Supplement | | 011210 | 037 | AP | 1999/06/08 | Manufacturing Change or Addition | | 011210 | 035 | AP | 1999/06/25 | Manufacturing Change or Addition | | 011210 | 032 | AP | 1993/12/01 | Manufacturing Change or Addition | | 011210 | 031 | AP | 1992/09/04 | Labeling Revision | | 011210 | 030 | AP | 1986/10/08 | Labeling Revision | | 011210 | 029 | AP | 1985/11/29 | Practioner Draft Labeling | | 011210 | 027 | AP | 1985/11/05 | Control Supplement | | 011210 | 026 | AP | 1985/06/13 | Control Supplement | | 011210 | 025 | AP | 1985/11/29 | Labeling Revision | | 011210 | 022 | AP | 1981/07/15 | Manufacturing Change or Addition | | 011210 | 021 | AP | 1980/07/03 | Control Supplement | | 011210 | 020 | AP | 1979/08/28 | Manufacturing Change or Addition | | 011210 | 019 | AP | 1979/07/06 | Expiration Date Change | | 011210 | 018 | AP | 1978/09/29 | Labeling Revision | | 011210 | 015 | AP | 1978/09/29 | Control Supplement | | 011210 | 014 | AP | 1978/10/24 | Control Supplement | | 011210 | 013 | AP | 1975/03/31 | Control Supplement | | 011210 | 011 | AP | 1974/12/30 | Supplement | | 011210 | 002 | AP | 1972/04/12 | Labeling Revision | | 011210 | 000 | AP | 1958/02/10 | Approval |
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