药品名称TANDEARIL
申请号012542产品号004
活性成分OXYPHENBUTAZONE市场状态停止上市
剂型或给药途径TABLET;ORAL规格100MG
治疗等效代码参比药物
批准日期1982/09/03申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New molecular entity (NME)审评分类Standard review drug
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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
012542056AP1985/03/25Labeling Revision
012542055AP1984/08/13Control Supplement
012542052AP1983/02/25Manufacturing Change or Addition
012542051AP1982/09/14Manufacturing Change or Addition
012542050AP1980/07/25Manufacturing Change or Addition
012542049AP1979/09/06Labeling Revision
012542048AP1979/08/08Manufacturing Change or Addition
012542047AP1982/09/03Control Supplement
012542046AP1978/11/08Control Supplement
012542045AP1977/12/16Labeling Revision
012542044AP1977/12/16Labeling Revision
012542043AP1979/04/26Package Change
012542042AP1978/02/28Labeling Revision
012542041AP1979/02/09Control Supplement
012542040AP1979/04/26Control Supplement
012542039AP1977/11/29Formulation Revision
012542037AP1978/01/05Labeling Revision
012542036AP1977/04/29Package Change
012542000AP1960/12/21Approval