药品名称METADATE CD
申请号021259产品号006
活性成分METHYLPHENIDATE HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格60MG
治疗等效代码AB2参比药物
批准日期2006/02/19申请机构UCB 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
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
021259029APLetter2015/04/20下载
021259029APLabel2015/04/21下载
021259027APLabel2013/12/17下载
021259027APLetter2013/12/17下载
021259026APLetter2013/06/06下载
021259026APLabel2013/06/11下载
021259024APLabel2013/05/06下载
021259024APLetter2013/05/07下载
021259023APLetter2013/05/07下载
021259023APLabel2013/05/06下载
021259022APLabel2010/10/18下载
021259022APLetter2010/10/20下载
021259021APLabel2009/04/23下载
021259021APLetter2009/05/14下载
021259020APLabel2007/05/07下载
021259020APLetter2007/05/09下载
021259019APLetter2008/08/28下载
021259019APLabel2008/08/29下载
021259018APLabel2006/08/11下载
021259018APLetter2006/08/14下载
021259017APLetter2006/03/01下载
021259008APLetter2003/09/29下载
021259006APLetter2003/06/22下载
021259005APLetter2003/06/08下载
021259001APLetter2002/04/09下载
021259001APLabel2002/04/09下载
021259000APLabel2001/04/03下载
021259000APReview2003/12/31下载
021259000APLetter2004/06/09下载
021259000APOther Important Information from FDA2007/05/18下载
021259000APMedication Guide2009/11/19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
021259029AP2015/04/17Labeling Revision
021259028AP2015/06/15Manufacturing Change or Addition
021259027AP2013/12/13Labeling Revision
021259026AP2013/06/04Labeling Revision
021259024AP2013/05/06Labeling Revision
021259023AP2013/05/06Labeling Revision
021259022AP2010/10/18Labeling Revision
021259021AP2009/04/16Labeling Revision
021259020AP2007/05/04Labeling Revision
021259019AP2008/08/26Labeling Revision
021259018AP2006/08/10Labeling Revision
021259017AP2006/02/19Control Supplement
021259008AP2003/09/22Manufacturing Change or Addition
021259006AP2003/06/19Manufacturing Change or Addition
021259005AP2003/05/27Manufacturing Change or Addition
021259004AP2002/11/06Package Change
021259003AP2002/11/06Manufacturing Change or Addition
021259002AP2002/09/18Manufacturing Change or Addition
021259001AP2002/04/09Labeling Revision
021259000AP2001/04/03Approval