药品名称ADRENACLICK
申请号020800产品号003
活性成分EPINEPHRINE市场状态处方药
剂型或给药途径INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS规格EQ 0.15MG/DELIVERY
治疗等效代码BX参比药物
批准日期2009/11/25申请机构AMEDRA PHARMACEUTICALS LLC
化学类型New dosage form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
020800034APLetter2016/05/19下载
020800034APLabel2016/05/20下载
020800030APLabel2014/10/21下载
020800030APLetter2014/10/22下载
020800027APLetter2014/07/28下载
020800027APLabel2014/07/29下载
020800024APLetter2014/04/24下载
020800024APLabel2014/04/25下载
020800023APReview2013/10/21下载
020800020APLabel2011/01/31下载
020800020APLetter2011/02/03下载
020800018APLabel2009/12/02下载
020800011APLetter2007/01/08下载
020800007APLetter2005/07/08下载
020800006APLetter2005/07/15下载
020800005APLetter2005/02/23下载
020800001APLetter2004/06/01下载
020800000APLetter2003/06/08下载
020800000APReview2005/04/08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
020800034AP2016/05/18Labeling Revision
020800030AP2014/10/17Manufacturing Change or Addition
020800029AP2014/10/13Manufacturing Change or Addition
020800028AP2014/10/23Manufacturing Change or Addition
020800027AP2014/07/25Labeling Revision
020800026AP2014/03/25Manufacturing Change or Addition
020800025AP2014/03/24Manufacturing Change or Addition
020800024AP2014/04/23Labeling Revision
020800023AP2013/09/06Manufacturing Change or Addition
020800020AP2011/01/26Labeling Revision
020800018AP2009/11/25Manufacturing Change or Addition
020800011AP2006/12/28Control Supplement
020800007AP2005/07/01Manufacturing Change or Addition
020800006AP2005/07/07Labeling Revision
020800005AP2005/02/22Manufacturing Change or Addition
020800001AP2004/05/28Patient Population Altered
020800000AP2003/05/30Approval