药品名称EPI E Z PEN JR
申请号019430产品号004
活性成分EPINEPHRINE市场状态停止上市
剂型或给药途径INJECTABLE;INTRAMUSCULAR规格0.15MG/DELIVERY
治疗等效代码参比药物
批准日期1995/08/03申请机构MYLAN SPECIALTY LP
化学类型New formulation or new manufacturer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
019430061APLetter2016/05/20下载
019430061APLabel2016/05/20下载
019430059APLetter2014/05/01下载
019430059APLabel2014/05/02下载
019430058APLetter2014/07/21下载
019430058APLabel2014/07/30下载
019430056APReview2014/01/16下载
019430055APReview2014/01/16下载
019430054APReview2014/01/15下载
019430053APLabel2012/08/20下载
019430053APLetter2012/08/22下载
019430047APLetter2009/05/26下载
019430044APLetter2008/10/01下载
019430044APLabel2008/10/03下载
019430025APLetter2003/12/22下载
019430012APLabel2003/04/15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
019430062AP2016/08/15Manufacturing Change or Addition
019430061AP2016/05/18Labeling Revision
019430060AP2016/03/03Manufacturing Change or Addition
019430059AP2014/04/30Labeling Revision
019430058AP2014/07/17Labeling Revision
019430057AP2013/12/13Manufacturing Change or Addition
019430056AP2013/11/08Manufacturing Change or Addition
019430055AP2013/09/16Manufacturing Change or Addition
019430054AP2013/07/23Manufacturing Change or Addition
019430053AP2012/08/20Labeling Revision
019430047AP2009/05/19Labeling Revision
019430044AP2008/09/26Labeling Revision
019430025AP2003/12/17Labeling Revision
019430018AP2002/12/19Control Supplement
019430017AP2002/08/21Control Supplement
019430016AP2002/06/28Manufacturing Change or Addition
019430015AP2002/04/16Expiration Date Change
019430014AP2002/02/20Control Supplement
019430012AP2001/08/27Labeling Revision
019430011AP2001/01/11Control Supplement
019430010AP2000/05/11Manufacturing Change or Addition
019430009AP1999/11/05Manufacturing Change or Addition
019430008AP1999/12/15Manufacturing Change or Addition
019430007AP1999/05/25Manufacturing Change or Addition
019430006AP1997/01/24Manufacturing Change or Addition
019430005AP1996/07/25Control Supplement
019430004AP1995/08/03Control Supplement
019430001AP1989/03/02Labeling Revision
019430000AP1987/12/22Approval