药品名称ASELLACRIN 10
申请号017726产品号001
活性成分SOMATROPIN市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格10 IU/VIAL
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SERONO LABORATORIES INC
化学类型New molecular entity (NME)审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
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历史专利信息
与本品相关的市场独占权保护信息
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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
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
017726037AP1984/12/20Labeling Revision
017726035AP1984/12/20Manufacturing Change or Addition
017726034AP1984/12/20Labeling Revision
017726032AP1984/06/22Labeling Revision
017726031AP1984/06/22Labeling Revision
017726030AP1983/07/18Control Supplement
017726028AP1983/01/11Control Supplement
017726027AP1983/07/21Control Supplement
017726026AP1983/07/21Labeling Revision
017726025AP1983/07/21Control Supplement
017726024AP1982/03/12Labeling Revision
017726023AP1982/09/15Package Change
017726022AP1982/07/29Manufacturing Change or Addition
017726020AP1981/09/28Control Supplement
017726019AP1981/09/21Control Supplement
017726017AP1983/07/21Manufacturing Change or Addition
017726016AP1983/07/21Labeling Revision
017726015AP1981/04/09Expiration Date Change
017726014AP1980/11/28Distributor
017726013AP1980/11/28Manufacturing Change or Addition
017726012AP1980/07/21Labeling Revision
017726006AP1980/02/21Control Supplement
017726005AP1978/07/19Control Supplement
017726004AP1978/07/19Labeling Revision
017726003AP1978/07/19Distributor
017726002AP1978/07/19Control Supplement
017726001AP1979/01/23Manufacturing Change or Addition
017726000AP1976/07/30Approval