药品名称DILANTIN-125
申请号008762产品号001
活性成分PHENYTOIN市场状态处方药
剂型或给药途径SUSPENSION;ORAL规格125MG/5ML
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PARKE DAVIS DIV WARNER LAMBERT CO
化学类型New active ingredient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
008762055APLabel2016/06/21下载
008762054APLetter2016/01/26下载
008762054APLabel2016/01/26下载
008762052APLabel2015/04/16下载
008762052APLetter2015/04/17下载
008762051APLabel2014/04/04下载
008762051APLetter2014/04/04下载
008762050APLetter2014/01/28下载
008762050APLabel2014/01/28下载
008762047APLetter2013/03/08下载
008762047APLabel2013/03/08下载
008762043APLabel2011/12/14下载
008762043APLetter2011/12/01下载
008762042APLetter2011/05/31下载
008762041APLetter2011/12/01下载
008762041APLabel2011/12/14下载
008762040APLabel2011/12/14下载
008762040APLetter2011/12/01下载
008762039APLetter2011/12/01下载
008762039APLabel2011/12/14下载
008762039APReview2012/06/26下载
008762038APLetter2011/01/24下载
008762038APLabel2011/01/25下载
008762038APMedication Guide2011/01/25下载
008762036APLabel2009/04/28下载
008762036APLetter2009/04/29下载
008762032APLetter2011/12/01下载
008762032APLabel2011/12/14下载
008762031APLetter2003/03/26下载
008762026APLetter2001/11/20下载
008762022APLetter2001/11/20下载
008762021APLetter2001/11/20下载
008762020APLetter2001/11/20下载
008762000APMedication Guide2011/12/16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
008762055AP2016/06/16Labeling Revision
008762054AP2016/01/25Labeling Revision
008762053AP2015/04/30Manufacturing Change or Addition
008762052AP2015/04/15Labeling Revision
008762051AP2014/04/03Labeling Revision
008762050AP2014/01/24Labeling Revision
008762049AP2013/09/06Manufacturing Change or Addition
008762048AP2013/08/08Manufacturing Change or Addition
008762047AP2013/03/06Labeling Revision
008762043AP2011/11/29Labeling Revision
008762042AP2011/05/27Labeling Revision
008762041AP2011/11/29Labeling Revision
008762040AP2011/11/29Labeling Revision
008762039AP2011/11/29Labeling Revision
008762038AP2011/01/17Labeling Revision
008762036AP2009/04/23Labeling Revision
008762032AP2011/11/29Labeling Revision
008762031AP2003/03/24Labeling Revision
008762030AP1998/02/24Package Change
008762029AP1998/02/24Control Supplement
008762028AP1998/02/19Control Supplement
008762027AP1997/10/15Control Supplement
008762026AP2001/11/20Labeling Revision
008762025AP1996/07/10Control Supplement
008762023AP1996/02/22Control Supplement
008762022AP2001/11/20Labeling Revision
008762021AP2001/11/20Labeling Revision
008762020AP2001/11/20Labeling Revision
008762019AP1990/03/23Labeling Revision
008762018AP1990/03/23Labeling Revision
008762017AP1990/03/23Labeling Revision
008762015AP1980/12/08Manufacturing Change or Addition
008762014AP1979/09/24Package Change
008762013AP1979/08/16Labeling Revision
008762012AP1978/11/22Labeling Revision
008762011AP1978/02/23Package Change
008762007AP1975/03/18Control Supplement
008762000AP1953/01/06Approval