药品名称ZONEGRAN
申请号020789产品号002
活性成分ZONISAMIDE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格50MG
治疗等效代码AB参比药物
批准日期2003/08/22申请机构SUNOVION PHARMACEUTICALS INC
化学类型New molecular entity (NME)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
020789034APLabel2016/04/07下载
020789034APLetter2016/04/08下载
020789030APLetter2011/09/27下载
020789030APLabel2011/09/29下载
020789029APLetter2011/05/31下载
020789026APLetter2010/04/21下载
020789026APLabel2010/04/20下载
020789025APLetter2009/05/04下载
020789025APLabel2009/05/13下载
020789024APLetter2010/04/21下载
020789024APLabel2010/04/20下载
020789022APLetter2009/05/04下载
020789022APLabel2009/05/13下载
020789021APLetter2015/06/22下载
020789021APLabel2015/07/14下载
020789019APLabel2006/11/22下载
020789019APLetter2006/12/04下载
020789012APLetter2012/01/30下载
020789012APLabel2012/01/31下载
020789005APLetter2002/10/07下载
020789005APLabel2002/10/07下载
020789001APLabel2003/08/28下载
020789001APLetter2003/08/28下载
020789000APReview2000/03/27下载
020789000APLetter2000/03/27下载
020789000APLabel2000/03/27下载
020789000APMedication Guide2009/09/30下载
020789000APOther Important Information from FDA2012/02/03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
020789035AP2016/08/11Manufacturing Change or Addition
020789034AP2016/04/06Labeling Revision
020789033AP2015/11/12Manufacturing Change or Addition
020789032AP2013/10/11Manufacturing Change or Addition
020789030AP2011/09/23Labeling Revision
020789029AP2011/05/27Labeling Revision
020789026AP2010/04/19Labeling Revision
020789025AP2009/04/23Labeling Revision
020789024AP2010/04/19Labeling Revision
020789022AP2009/04/23Labeling Revision
020789021AP2015/06/19Labeling Revision
020789019AP2006/11/20Labeling Revision
020789012AP2012/01/26Labeling Revision
020789008AP2002/06/13Control Supplement
020789007AP2002/05/15Manufacturing Change or Addition
020789006AP2002/04/01Manufacturing Change or Addition
020789005AP2002/10/07Labeling Revision
020789004AP2002/02/06Manufacturing Change or Addition
020789003AP2001/11/28Control Supplement
020789002AP2000/12/04Manufacturing Change or Addition
020789001AP2003/08/22Manufacturing Change or Addition
020789000AP2000/03/27Approval