药品名称CARBATROL
申请号020712产品号002
活性成分CARBAMAZEPINE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格300MG
治疗等效代码AB参比药物
批准日期1997/09/30申请机构SHIRE DEVELOPMENT INC
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
59120132016/06/15U-277PDF格式
历史专利信息
53265702011/07/05U-215PDF格式
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
020712035APLetter2013/03/25下载
020712035APLabel2013/03/26下载
020712035APMedication Guide2013/05/22下载
020712034APLetter2011/09/06下载
020712032APLetter2013/03/25下载
020712032APLabel2013/03/26下载
020712032APMedication Guide2013/05/22下载
020712031APMedication Guide2011/01/31下载
020712031APLabel2011/01/31下载
020712031APLetter2011/02/03下载
020712030APLabel2009/04/28下载
020712030APLetter2009/04/29下载
020712029APLabel2007/12/12下载
020712029APOther2007/12/31下载
020712029APLetter2008/01/09下载
020712025APLabel2006/07/03下载
020712025APLetter2006/07/13下载
020712024APLetter2006/01/30下载
020712000APReview2007/04/17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
020712035AP2013/03/22Labeling Revision
020712034AP2011/08/22Labeling Revision
020712032AP2013/03/22Labeling Revision
020712031AP2011/01/26Labeling Revision
020712030AP2009/04/23Labeling Revision
020712029AP2007/12/11Labeling Revision
020712025AP2006/06/30Labeling Revision
020712024AP2006/01/24Labeling Revision
020712016AP2002/08/07Manufacturing Change or Addition
020712015AP2002/02/21Manufacturing Change or Addition
020712014AP2001/10/30Manufacturing Change or Addition
020712013AP2000/08/08Manufacturing Change or Addition
020712012AP2000/08/08Manufacturing Change or Addition
020712011AP2001/05/17Control Supplement
020712010AP2000/06/14Manufacturing Change or Addition
020712009AP2000/01/19Control Supplement
020712008AP1999/11/08Package Change
020712007AP1999/12/22Manufacturing Change or Addition
020712006AP1999/06/28Package Change
020712005AP1999/06/28Package Change
020712003AP1999/01/27Manufacturing Change or Addition
020712002AP1999/01/27Control Supplement
020712001AP1998/07/24Control Supplement
020712000AP1997/09/30Approval