药品名称STADOL
申请号017857产品号004
活性成分BUTORPHANOL TARTRATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格2MG/ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构APOTHECON INC DIV BRISTOL MYERS SQUIBB
化学类型New molecular entity (NME)审评分类Priority 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
017857058AP2001/11/05Manufacturing Change or Addition
017857054AP1999/05/25Labeling Revision
017857053AP1998/03/13Labeling Revision
017857051AP1998/03/13Labeling Revision
017857050AP1993/04/16Labeling Revision
017857049AP1993/04/16Labeling Revision
017857048AP1992/05/01Labeling Revision
017857047AP1990/09/19Manufacturing Change or Addition
017857044AP1988/12/12Control Supplement
017857043AP1987/08/04Labeling Revision
017857042AP1987/01/14Control Supplement
017857041AP1986/10/20Control Supplement
017857039AP1987/03/05New Dosage Regimen
017857037AP1985/01/10Package Change
017857036AP1985/07/22Manufacturing Change or Addition
017857035AP1984/10/19Labeling Revision
017857034AP1984/06/07Labeling Revision
017857033AP1984/06/07Labeling Revision
017857032AP1984/05/09Labeling Revision
017857031AP1984/04/16Labeling Revision
017857030AP1984/04/04Labeling Revision
017857029AP1984/10/24Control Supplement
017857027AP1984/05/07Control Supplement
017857026AP1984/01/17Labeling Revision
017857025AP1983/09/07Labeling Revision
017857024AP1983/04/20Control Supplement
017857023AP1983/04/20Control Supplement
017857022AP1982/02/26Patient Population Altered
017857020AP1981/05/14Labeling Revision
017857019AP1981/05/14Labeling Revision
017857016AP1981/09/02Expiration Date Change
017857015AP1980/06/03Control Supplement
017857013AP1987/08/04Control Supplement
017857012AP1987/08/04Control Supplement
017857011AP1979/05/15Package Change
017857010AP1982/09/07Manufacturing Change or Addition
017857009AP1979/11/20Labeling Revision
017857007AP1979/11/20Labeling Revision
017857006AP1979/11/20Labeling Revision
017857005AP1979/11/20Labeling Revision
017857004AP1978/09/14Package Change
017857003AP1978/09/14Formulation Revision
017857002AP1978/09/14Formulation Revision
017857001AP1978/09/14Labeling Revision
017857000AP1978/08/22Approval