| 药品名称 | ASELLACRIN 2 | | 申请号 | 017726 | 产品号 | 002 | | 活性成分 | SOMATROPIN | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 2 IU/VIAL | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1983/07/21 | 申请机构 | SERONO LABORATORIES 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 | | 无 |
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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 | | 017726 | 037 | AP | 1984/12/20 | Labeling Revision | | 017726 | 035 | AP | 1984/12/20 | Manufacturing Change or Addition | | 017726 | 034 | AP | 1984/12/20 | Labeling Revision | | 017726 | 032 | AP | 1984/06/22 | Labeling Revision | | 017726 | 031 | AP | 1984/06/22 | Labeling Revision | | 017726 | 030 | AP | 1983/07/18 | Control Supplement | | 017726 | 028 | AP | 1983/01/11 | Control Supplement | | 017726 | 027 | AP | 1983/07/21 | Control Supplement | | 017726 | 026 | AP | 1983/07/21 | Labeling Revision | | 017726 | 025 | AP | 1983/07/21 | Control Supplement | | 017726 | 024 | AP | 1982/03/12 | Labeling Revision | | 017726 | 023 | AP | 1982/09/15 | Package Change | | 017726 | 022 | AP | 1982/07/29 | Manufacturing Change or Addition | | 017726 | 020 | AP | 1981/09/28 | Control Supplement | | 017726 | 019 | AP | 1981/09/21 | Control Supplement | | 017726 | 017 | AP | 1983/07/21 | Manufacturing Change or Addition | | 017726 | 016 | AP | 1983/07/21 | Labeling Revision | | 017726 | 015 | AP | 1981/04/09 | Expiration Date Change | | 017726 | 014 | AP | 1980/11/28 | Distributor | | 017726 | 013 | AP | 1980/11/28 | Manufacturing Change or Addition | | 017726 | 012 | AP | 1980/07/21 | Labeling Revision | | 017726 | 006 | AP | 1980/02/21 | Control Supplement | | 017726 | 005 | AP | 1978/07/19 | Control Supplement | | 017726 | 004 | AP | 1978/07/19 | Labeling Revision | | 017726 | 003 | AP | 1978/07/19 | Distributor | | 017726 | 002 | AP | 1978/07/19 | Control Supplement | | 017726 | 001 | AP | 1979/01/23 | Manufacturing Change or Addition | | 017726 | 000 | AP | 1976/07/30 | Approval |
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