药品名称SEPTOCAINE
申请号020971产品号001
活性成分ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
治疗等效代码AP参比药物
批准日期2000/04/03申请机构DEPROCO INC
化学类型审评分类Standard 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
020971023APLetter2010/11/18下载
020971023APReview2015/01/28下载
020971021APReview2015/01/28下载
020971021APLetter2010/02/26下载
020971021APLabel2010/03/03下载
020971017APLabel2006/11/13下载
020971017APLetter2006/11/14下载
020971013APReview2013/06/03下载
020971009APReview2013/06/03下载
020971009APLetter2005/02/08下载
020971007APLetter2004/10/18下载
020971000APLetter2000/04/03下载
020971000APLabel2000/04/03下载
020971000APReview2002/08/14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
020971034AP2015/01/26Manufacturing Change or Addition
020971033AP2014/06/05Manufacturing Change or Addition
020971032AP2014/06/05Manufacturing Change or Addition
020971030AP2014/01/31Manufacturing Change or Addition
020971029AP2014/02/14Manufacturing Change or Addition
020971028AP2013/03/08Manufacturing Change or Addition
020971023AP2010/11/12Labeling Revision
020971021AP2010/02/22Labeling Revision
020971017AP2006/11/09Labeling Revision
020971013AP2006/03/30Labeling Revision
020971009AP2005/02/04Labeling Revision
020971007AP2004/10/14Labeling Revision
020971001AP2002/07/23Control Supplement
020971000AP2000/04/03Approval