药品名称MOBAN
申请号017111产品号007
活性成分MOLINDONE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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ENDO 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
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
017111067APLabel2010/12/04下载
017111067APLetter2010/12/06下载
017111066APLabel2009/07/23下载
017111066APLetter2009/07/23下载
017111063APLetter2008/08/19下载
017111063APLabel2008/08/29下载
017111062APLetter2008/03/17下载
017111062APLabel2008/03/17下载
017111055APLetter2003/04/09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
017111067AP2010/12/01Labeling Revision
017111066AP2009/07/19Labeling Revision
017111063AP2008/08/14Labeling Revision
017111062AP2008/03/12Labeling Revision
017111055AP2001/05/22Labeling Revision
017111054AP1998/08/21Control Supplement
017111053AP1998/08/21Manufacturing Change or Addition
017111051AP1996/04/25Control Supplement
017111050AP1995/08/28Control Supplement
017111049AP1995/08/28Control Supplement
017111048AP1995/08/28Control Supplement
017111047AP1994/08/12Manufacturing Change or Addition
017111046AP1988/08/08Manufacturing Change or Addition
017111045AP1988/06/28Labeling Revision
017111044AP1988/06/28Package Change
017111043AP1987/09/23Manufacturing Change or Addition
017111039AP1986/06/11Package Change
017111036AP1985/06/26Package Change
017111033AP1982/11/19Labeling Revision
017111030AP1981/03/24Labeling Revision
017111029AP1981/01/06Formulation Revision
017111028AP1979/08/16Labeling Revision
017111027AP1979/09/27Package Change
017111026AP1979/05/10Labeling Revision
017111023AP1979/12/20Expiration Date Change
017111021AP1981/01/05Formulation Revision
017111017AP1977/06/07Control Supplement
017111014AP1977/02/07Formulation Revision
017111012AP1977/02/07Formulation Revision
017111011AP1977/05/27Package Change
017111010AP1977/03/14Control Supplement
017111008AP1976/08/26Package Change
017111007AP1976/09/20Labeling Revision
017111004AP1974/09/23Control Supplement
017111000AP1974/01/18Approval