药品名称MARCAINE HYDROCHLORIDE
申请号016964产品号001
活性成分BUPIVACAINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格0.25%
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HOSPIRA 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)
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
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
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
016964070APLabel2012/01/30下载
016964070APLetter2012/02/01下载
016964069APLetter2010/02/25下载
016964069APLabel2010/02/25下载
016964061APLabel2005/11/01下载
016964061APLetter2005/11/01下载
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
016964073AP2014/12/15Manufacturing Change or Addition
016964072AP2014/09/19Manufacturing Change or Addition
016964071AP2013/07/30Manufacturing Change or Addition
016964070AP2012/01/30Labeling Revision
016964069AP2010/02/19Labeling Revision
016964061AP2005/10/30Labeling Revision
016964053AP2001/01/31Control Supplement
016964052AP1999/03/11Labeling Revision
016964051AP1999/03/11Labeling Revision
016964050AP1997/04/09Manufacturing Change or Addition
016964048AP1999/03/11Labeling Revision
016964047AP1993/01/25Control Supplement
016964046AP1999/03/11Labeling Revision
016964045AP1991/08/08Labeling Revision
016964044AP1991/02/06Package Change
016964043AP1991/02/06Control Supplement
016964042AP1988/04/27Package Change
016964041AP1987/07/13Labeling Revision
016964040AP1987/09/15Control Supplement
016964039AP1987/01/27Labeling Revision
016964038AP1987/01/27Package Change
016964037AP1985/08/24Labeling Revision
016964036AP1985/08/19Labeling Revision
016964035AP1985/09/11Labeling Revision
016964034AP1983/12/01Labeling Revision
016964031AP1985/05/20Package Change
016964030AP1983/01/21Control Supplement
016964029AP1983/07/13Labeling Revision
016964028AP1983/07/13Control Supplement
016964025AP1984/03/02Expiration Date Change
016964024AP1983/11/21Practioner Draft Labeling
016964023AP1981/12/28Labeling Revision
016964022AP1981/08/21Labeling Revision
016964021AP1981/08/21Control Supplement
016964020AP1982/01/27Control Supplement
016964019AP1980/11/03Labeling Revision
016964018AP1979/12/06Control Supplement
016964017AP1979/06/18Labeling Revision
016964016AP1979/04/04Control Supplement
016964015AP1980/08/21Labeling Revision
016964014AP1980/08/21Control Supplement
016964013AP1979/04/04Control Supplement
016964012AP1978/06/15Control Supplement
016964011AP1978/06/15Control Supplement
016964008AP1976/07/07Manufacturing Change or Addition
016964007AP1976/11/30Final Printed Labeling - MarkIV
016964006AP1976/06/10Control Supplement
016964005AP1976/06/07Control Supplement
016964004AP1976/06/10Labeling Revision
016964003AP1976/01/13Labeling Revision
016964000AP1972/10/03Approval