药品名称TUSSIONEX PENNKINETIC
申请号019111产品号001
活性成分CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX市场状态处方药
剂型或给药途径SUSPENSION, EXTENDED RELEASE;ORAL规格EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
治疗等效代码AB参比药物
批准日期1987/12/31申请机构UCB INC
化学类型New combination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
019111018APLabel2015/04/02下载
019111018APLetter2015/04/03下载
019111016APLetter2011/06/09下载
019111015APLabel2008/03/13下载
019111015APLetter2008/03/13下载
019111011APLetter2003/11/25下载
019111011APReview2008/08/01下载
019111000APOther Important Information from FDA2008/03/13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
019111018AP2015/04/01Labeling Revision
019111017AP2014/03/21Manufacturing Change or Addition
019111016AP2011/06/02Manufacturing Change or Addition
019111015AP2008/03/11Labeling Revision
019111011AP2003/11/12Labeling Revision
019111009AP2001/06/07Control Supplement
019111008AP2000/11/13Control Supplement
019111007AP2000/03/03Manufacturing Change or Addition
019111006AP2000/02/29Control Supplement
019111005AP1999/07/30Manufacturing Change or Addition
019111004AP1996/12/27Control Supplement
019111003AP1993/11/26Labeling Revision
019111002AP1993/11/26Labeling Revision
019111001AP1993/12/20Manufacturing Change or Addition
019111000AP1987/12/31Approval