药品名称TEGRETOL
申请号018281产品号001
活性成分CARBAMAZEPINE市场状态处方药
剂型或给药途径TABLET, CHEWABLE;ORAL规格100MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构NOVARTIS PHARMACEUTICALS CORP
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
018281055APLabel2012/12/13下载
018281055APLetter2012/12/13下载
018281053APLetter2013/03/08下载
018281053APLabel2013/03/08下载
018281051APLetter2014/01/17下载
018281051APLabel2014/01/17下载
018281050APMedication Guide2011/03/07下载
018281050APLabel2011/03/07下载
018281050APLetter2011/03/07下载
018281049APMedication Guide2011/03/07下载
018281049APLabel2011/03/07下载
018281049APLetter2011/03/07下载
018281048APLetter2009/05/01下载
018281048APLabel2009/05/12下载
018281047APLetter2014/09/17下载
018281047APLabel2014/09/19下载
018281046APLabel2007/12/12下载
018281046APLetter2008/01/09下载
018281045APLetter2015/09/01下载
018281045APLabel2015/09/03下载
018281044APLabel2007/08/17下载
018281044APLetter2007/08/17下载
018281039APLetter2001/03/07下载
018281039APLabel2001/03/07下载
018281039APReview2007/07/06下载
018281031APReview2007/07/06下载
018281000APMedication Guide2012/12/18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
018281056AP2013/11/08Manufacturing Change or Addition
018281055AP2012/12/11Labeling Revision
018281054AP2011/10/30Labeling Revision
018281053AP2013/03/06Labeling Revision
018281051AP2014/01/16Labeling Revision
018281050AP2011/03/03Labeling Revision
018281049AP2011/03/03Labeling Revision
018281048AP2009/04/23Labeling Revision
018281047AP2014/09/16Labeling Revision
018281046AP2007/12/11Labeling Revision
018281045AP2015/08/28Labeling Revision
018281044AP2007/08/16Labeling Revision
018281043AP2002/03/05Control Supplement
018281042AP2002/01/28Control Supplement
018281041AP2001/11/15Manufacturing Change or Addition
018281040AP2000/05/18Manufacturing Change or Addition
018281039AP2001/03/07Labeling Revision
018281038AP2000/04/11Manufacturing Change or Addition
018281037AP2000/04/10Labeling Revision
018281036AP1999/04/23Package Change
018281035AP1999/01/27Manufacturing Change or Addition
018281034AP1998/07/15Labeling Revision
018281033AP2000/04/10Labeling Revision
018281032AP1998/07/15Labeling Revision
018281031AP1998/07/15Labeling Revision
018281030AP1998/07/15Labeling Revision
018281028AP1993/10/06Control Supplement
018281022AP1991/03/14Control Supplement
018281021AP1992/11/23Formulation Revision
018281020AP1995/02/03Control Supplement
018281018AP1990/03/26Labeling Revision
018281016AP1990/03/29Manufacturing Change or Addition
018281015AP1990/03/29Manufacturing Change or Addition
018281014AP1990/03/27Manufacturing Change or Addition
018281013AP1989/07/21Labeling Revision
018281012AP1989/04/07Package Change
018281011AP1988/08/01Labeling Revision
018281010AP1995/10/11Patient Population Altered
018281009AP1987/07/31Labeling Revision
018281008AP1986/09/11Manufacturing Change or Addition
018281006AP1986/02/03Package Change
018281005AP1986/01/10Labeling Revision
018281004AP1986/01/10Labeling Revision
018281003AP1983/06/21Package Change
018281001AP1982/02/11Labeling Revision
018281000AP1981/12/14Approval