药品名称SKELAXIN
申请号013217产品号001
活性成分METAXALONE市场状态停止上市
剂型或给药途径TABLET;ORAL规格400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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Approved Prior to Jan 1, 1982申请机构KING PHARMACEUTICALS 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
历史专利信息
64071282021/12/03U-189PDF格式
66831022021/12/03U-189PDF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
013217053APLetter2008/11/03下载
013217053APLabel2012/11/27下载
013217046APLabel2006/12/04下载
013217046APLetter2006/12/04下载
013217045APReview2009/09/14下载
013217044APLetter2002/06/20下载
013217044APReview2006/05/10下载
013217043APReview2009/09/14下载
013217041APReview2009/09/14下载
013217040APReview2009/09/14下载
013217037APReview2009/09/14下载
013217036APLetter2002/08/30下载
013217036APLabel2002/08/30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
013217059AP2016/10/07Manufacturing Change or Addition
013217058AP2016/05/09Manufacturing Change or Addition
013217056AP2014/09/29Manufacturing Change or Addition
013217055AP2014/01/27Manufacturing Change or Addition
013217053AP2008/10/31Labeling Revision
013217046AP2006/11/24Labeling Revision
013217045AP2002/06/03Control Supplement
013217044AP2002/06/20Labeling Revision
013217043AP2002/04/16Manufacturing Change or Addition
013217041AP2001/09/26Manufacturing Change or Addition
013217040AP2001/01/31Manufacturing Change or Addition
013217037AP2000/05/04Control Supplement
013217036AP2002/08/30Formulation Revision
013217035AP1998/09/18Manufacturing Change or Addition
013217034AP1999/04/13Control Supplement
013217033AP1998/03/26Manufacturing Change or Addition
013217032AP1999/04/13Control Supplement
013217031AP1997/03/20Manufacturing Change or Addition
013217030AP1997/07/07Control Supplement
013217029AP1995/06/28Control Supplement
013217028AP1995/03/27Package Change
013217027AP1995/01/05Manufacturing Change or Addition
013217025AP1992/07/27Package Change
013217024AP1989/02/28Control Supplement
013217020AP1987/02/26Manufacturing Change or Addition
013217019AP1985/12/31Control Supplement
013217018AP1985/05/31Control Supplement
013217017AP1985/12/04Labeling Revision
013217015AP1984/03/27Package Change
013217014AP1984/03/27Manufacturing Change or Addition
013217012AP1981/01/16Manufacturing Change or Addition
013217011AP1981/01/16Labeling Revision
013217010AP1980/04/15Manufacturing Change or Addition
013217009AP1980/02/13Labeling Revision
013217008AP1979/02/26Expiration Date Change
013217006AP1977/04/04Formulation Revision
013217000AP1962/08/13Approval