药品名称SERZONE
申请号020152产品号005
活性成分NEFAZODONE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1994/12/22申请机构BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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
020152035APLetter2005/01/13下载
020152035APLabel2005/01/13下载
020152034APLetter2004/06/01下载
020152033APLetter2002/06/20下载
020152031APLetter2003/05/30下载
020152031APReview2007/05/09下载
020152029APLetter2002/01/08下载
020152028APLetter2001/12/04下载
020152028APReview2007/07/06下载
020152026APLetter2001/03/21下载
020152026APReview2005/01/06下载
020152011APLetter1998/03/31下载
020152010APReview2007/05/09下载
020152009APReview2007/05/09下载
020152006APReview2007/07/06下载
020152000APOther Important Information from FDA2007/05/09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
020152035AP2005/01/12Labeling Revision
020152034AP2004/05/27Labeling Revision
020152033AP2002/06/20Labeling Revision
020152031AP2003/05/05Labeling Revision
020152030AP2002/04/23Manufacturing Change or Addition
020152029AP2002/01/08Labeling Revision
020152028AP2001/12/04Labeling Revision
020152027AP2002/03/11Control Supplement
020152026AP2001/03/21Labeling Revision
020152025AP2001/01/23Labeling Revision
020152024AP2000/11/09Manufacturing Change or Addition
020152023AP2000/06/01Labeling Revision
020152022AP2000/04/10Manufacturing Change or Addition
020152021AP1999/11/30Control Supplement
020152020AP1999/09/09Labeling Revision
020152019AP2000/06/01Labeling Revision
020152018AP1999/09/23Manufacturing Change or Addition
020152017AP2000/06/01Labeling Revision
020152016AP2000/06/01Labeling Revision
020152015AP2000/06/01Labeling Revision
020152013AP1999/01/27Manufacturing Change or Addition
020152012AP1997/08/06Labeling Revision
020152011AP1998/03/31Labeling Revision
020152010AP1997/05/05Labeling Revision
020152009AP1997/05/05Labeling Revision
020152008AP1996/12/02Manufacturing Change or Addition
020152007AP1997/01/13Control Supplement
020152006AP2000/07/26Labeling Revision
020152005AP1997/02/06Manufacturing Change or Addition
020152004AP1996/03/28Manufacturing Change or Addition
020152003AP1996/06/25Labeling Revision
020152002AP1996/03/20Manufacturing Change or Addition
020152001AP1996/03/28Manufacturing Change or Addition
020152000AP1994/12/22Approval