药品名称GABITRIL
申请号020646产品号003
活性成分TIAGABINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格16MG
治疗等效代码参比药物
批准日期1997/09/30申请机构CEPHALON 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
58665902016/04/29PDF格式
59589512017/06/10PDF格式
历史专利信息
50100902011/09/30PDF格式
53547602012/03/24PDF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
020646021APLetter2016/08/10下载
020646021APLabel2016/08/10下载
020646020APLetter2012/01/30下载
020646018APLetter2015/11/09下载
020646018APLabel2015/11/12下载
020646017APLabel2010/10/11下载
020646017APLetter2010/10/13下载
020646016APLetter2009/05/04下载
020646016APLabel2009/05/12下载
020646015APLabel2005/12/05下载
020646015APLetter2005/12/06下载
020646014APLetter2005/02/17下载
020646014APLabel2005/02/17下载
020646000APOther Important Information from FDA2005/04/15下载
020646000APReview2010/01/07下载
020646000APMedication Guide2010/10/13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
020646021AP2016/08/09Labeling Revision
020646020AP2012/01/25Labeling Revision
020646018AP2015/11/04Labeling Revision
020646017AP2010/10/11Labeling Revision
020646016AP2009/04/23Labeling Revision
020646015AP2005/11/29Manufacturing Change or Addition
020646014AP2005/02/14Labeling Revision
020646011AP2001/10/03Manufacturing Change or Addition
020646010AP2001/10/03Package Change
020646009AP2001/07/27Manufacturing Change or Addition
020646008AP2000/05/16Manufacturing Change or Addition
020646007AP2000/05/17Control Supplement
020646006AP1999/08/23Expiration Date Change
020646005AP1999/04/16Labeling Revision
020646004AP1999/04/16Manufacturing Change or Addition
020646003AP1998/07/31Control Supplement
020646002AP1998/05/08Package Change
020646001AP1997/10/09Control Supplement
020646000AP1997/09/30Approval