药品名称XYLOCAINE PRESERVATIVE FREE
申请号016801产品号001
活性成分LIDOCAINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格2%
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FRESENIUS KABI USA LLC
化学类型New formulation or new manufacturer审评分类Standard review drug
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申请号修订号审批结论审批日期审批内容
016801042AP2013/04/18Manufacturing Change or Addition
016801041AP2013/03/28Labeling Revision
016801035AP2000/12/08Control Supplement
016801034AP1997/02/20Expiration Date Change
016801033AP1997/02/04Labeling Revision
016801032AP1995/05/31Control Supplement
016801031AP1994/07/15Package Change
016801030AP1993/02/18Manufacturing Change or Addition
016801029AP1989/07/11Control Supplement
016801028AP1988/08/26Labeling Revision
016801027AP1988/01/19Labeling Revision
016801026AP1987/09/16Manufacturing Change or Addition
016801025AP1986/09/04Labeling Revision
016801024AP1986/09/04Control Supplement
016801023AP1986/04/03Expiration Date Change
016801022AP1983/09/02Labeling Revision
016801021AP1982/07/08Manufacturing Change or Addition
016801020AP1982/03/25Control Supplement
016801019AP1982/02/22Labeling Revision
016801018AP1983/04/27Practioner Draft Labeling
016801017AP1982/07/22Labeling Revision
016801016AP1982/07/22Control Supplement
016801015AP1980/12/15Labeling Revision
016801014AP1979/12/07Labeling Revision
016801013AP1979/12/07Control Supplement
016801011AP1979/12/28Control Supplement
016801010AP1978/10/12Control Supplement
016801009AP1978/09/29Labeling Revision
016801008AP1978/09/29Control Supplement
016801007AP1976/05/27Final Printed Labeling - MarkIV
016801006AP1976/04/15Control Supplement
016801004AP1975/02/12Labeling Revision
016801000AP1969/10/06Approval