药品名称DARVOCET-N 50
申请号017122产品号001
活性成分ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格325MG;50MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构XANODYNE PHARMACEUTICS INC
化学类型New combination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
017122062APLabel2009/10/01下载
017122062APMedication Guide2009/10/01下载
017122062APLetter2009/10/26下载
017122061APLetter2009/11/13下载
017122061APMedication Guide2009/10/01下载
017122061APLabel2009/10/01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
017122062AP2009/09/25Labeling Revision
017122061AP2009/09/25Labeling Revision
017122059AP2007/01/24Control Supplement
017122058AP2006/05/11Manufacturing Change or Addition
017122057AP2005/07/13Manufacturing Change or Addition
017122056AP2005/04/12Manufacturing Change or Addition
017122055AP2005/02/03Manufacturing Change or Addition
017122054AP2005/02/03Manufacturing Change or Addition
017122053AP1999/02/24Manufacturing Change or Addition
017122052AP1998/10/05Manufacturing Change or Addition
017122051AP1998/08/10Control Supplement
017122050AP1998/04/02Package Change
017122048AP1997/05/15Control Supplement
017122047AP2001/10/30Labeling Revision
017122046AP2001/10/30Labeling Revision
017122045AP1995/03/14Formulation Revision
017122044AP1994/04/05Manufacturing Change or Addition
017122043AP1994/09/02Labeling Revision
017122042AP1992/09/15Control Supplement
017122041AP1993/12/17Control Supplement
017122040AP1994/08/23Labeling Revision
017122039AP1995/03/20Labeling Revision
017122034AP1987/04/16Control Supplement
017122030AP1986/10/17Labeling Revision
017122029AP1986/04/21Labeling Revision
017122028AP1986/04/03Labeling Revision
017122025AP1984/08/16Control Supplement
017122024AP1984/08/07Labeling Revision
017122023AP1981/10/28Labeling Revision
017122022AP1981/05/20Labeling Revision
017122021AP1980/04/16Labeling Revision
017122020AP1979/09/26Labeling Revision
017122019AP1979/11/06Manufacturing Change or Addition
017122018AP1979/07/17Labeling Revision
017122016AP1979/06/29Formulation Revision
017122015AP1978/10/16Package Change
017122014AP1980/01/21Control Supplement
017122013AP1977/05/06Package Change
017122012AP1977/05/06Package Change
017122011AP1977/06/10Labeling Revision
017122009AP1976/09/15Expiration Date Change
017122005AP1974/06/18Control Supplement
017122000AP1972/12/19Approval