药品名称DEMEROL
申请号005010产品号004
活性成分MEPERIDINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格100MG
治疗等效代码AA参比药物
批准日期Approved Prior to Jan 1, 1982申请机构US PHARMACEUTICAL HOLDINGS II LLC
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
005010051APLetter2011/11/02下载
005010051APLabel2011/10/31下载
005010050APLabel2011/04/11下载
005010050APLetter2011/04/13下载
005010049APLetter2009/03/10下载
005010049APLabel2009/03/17下载
005010048APLetter2003/06/08下载
005010047APLetter2003/03/10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
005010051AP2011/10/31Labeling Revision
005010050AP2011/04/11Labeling Revision
005010049AP2009/03/05Labeling Revision
005010048AP2003/05/15Labeling Revision
005010047AP2003/02/26Labeling Revision
005010046AP2000/10/17Control Supplement
005010045AP1995/10/10Control Supplement
005010044AP1995/03/16Package Change
005010043AP1995/03/16Control Supplement
005010042AP1995/03/16Package Change
005010041AP1992/09/10Control Supplement
005010040AP1992/09/29Control Supplement
005010039AP1992/09/29Control Supplement
005010038AP1992/07/30Package Change
005010037AP1991/02/12Manufacturing Change or Addition
005010036AP1990/09/12Manufacturing Change or Addition
005010035AP1990/01/25Manufacturing Change or Addition
005010034AP1989/05/24Manufacturing Change or Addition
005010033AP1989/05/25Manufacturing Change or Addition
005010032AP1989/04/03Package Change
005010031AP1997/07/24Labeling Revision
005010030AP1988/01/06Labeling Revision
005010029AP1986/07/18Labeling Revision
005010028AP1986/05/12Control Supplement
005010027AP1985/06/04Control Supplement
005010026AP1985/05/20Manufacturing Change or Addition
005010025AP1985/05/20Control Supplement
005010024AP1984/01/17Control Supplement
005010023AP1983/03/28Control Supplement
005010022AP1983/03/28Labeling Revision
005010021AP1983/03/28Control Supplement
005010020AP1983/03/28Control Supplement
005010019AP1983/03/28Package Change
005010018AP1983/03/28Package Change
005010017AP1982/09/07Control Supplement
005010014AP1979/07/26Labeling Revision
005010013AP1978/07/21Labeling Revision
005010012AP1978/07/27Labeling Revision
005010011AP1977/12/02Control Supplement
005010010AP1978/01/04Manufacturing Change or Addition
005010009AP1976/08/10Formulation Revision
005010008AP1976/05/04Labeling Revision
005010004AP1974/01/18Labeling Revision
005010000AP1942/11/10Approval