药品名称BUSPAR
申请号018731产品号001
活性成分BUSPIRONE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1986/09/29申请机构BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
化学类型New molecular entity (NME)审评分类Priority 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
018731051APLabel2010/11/22下载
018731051APLetter2010/11/30下载
018731048APLetter2007/09/25下载
018731048APLabel2007/09/26下载
018731046APLetter2002/02/07下载
018731045APLabel2003/04/14下载
018731043APLetter2001/07/19下载
018731043APLabel2001/07/19下载
018731043APReview2004/04/14下载
018731039APLabel2003/04/14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
018731051AP2010/11/22Labeling Revision
018731048AP2007/09/21Labeling Revision
018731046AP2002/02/07Labeling Revision
018731045AP2001/05/03Labeling Revision
018731043AP2001/07/19Patient Population Altered
018731042AP2000/04/25Package Change
018731041AP1999/11/01Manufacturing Change or Addition
018731040AP1999/07/27Package Change
018731039AP2001/05/03Labeling Revision
018731038AP1999/01/27Manufacturing Change or Addition
018731036AP1998/06/19Manufacturing Change or Addition
018731035AP1998/04/03Package Change
018731034AP1998/05/20Labeling Revision
018731033AP1998/05/20Labeling Revision
018731032AP1996/12/30Package Change
018731031AP1996/04/22New Dosage Regimen
018731030AP1996/06/19Manufacturing Change or Addition
018731029AP1996/03/20Control Supplement
018731027AP1996/04/22Labeling Revision
018731026AP1993/09/23Labeling Revision
018731025AP1996/04/22Formulation Revision
018731023AP1990/10/05Control Supplement
018731021AP1990/01/26Manufacturing Change or Addition
018731020AP1998/03/02Labeling Revision
018731019AP1990/01/26Manufacturing Change or Addition
018731018AP1991/07/31Labeling Revision
018731017AP1989/04/28Manufacturing Change or Addition
018731016AP1988/10/13Package Change
018731015AP1989/03/02Control Supplement
018731014AP1989/03/02Control Supplement
018731011AP1988/11/02Labeling Revision
018731010AP1988/06/23Manufacturing Change or Addition
018731009AP1987/08/10Labeling Revision
018731008AP1989/07/25Labeling Revision
018731006AP1989/07/25Package Change
018731005AP1987/04/23Manufacturing Change or Addition
018731004AP1986/12/16Package Change
018731003AP1986/12/16Package Change
018731000AP1986/09/29Approval