药品名称MOTRIN
申请号017463产品号003
活性成分IBUPROFEN市场状态停止上市
剂型或给药途径TABLET;ORAL规格300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
化学类型New molecular entity (NME)审评分类Priority 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
017463105APLabel2007/09/11下载
017463105APLetter2007/09/11下载
017463104APLabel2006/01/25下载
017463104APLetter2006/01/30下载
017463000APMedication Guide2009/12/04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
017463105AP2007/09/10Labeling Revision
017463104AP2006/01/24Labeling Revision
017463103AP2001/05/14Control Supplement
017463102AP2001/06/20Manufacturing Change or Addition
017463101AP1999/11/29Control Supplement
017463099AP1999/07/20Manufacturing Change or Addition
017463098AP1995/11/20Control Supplement
017463097AP1995/11/15Control Supplement
017463095AP1995/03/23Control Supplement
017463091AP1992/10/19Manufacturing Change or Addition
017463089AP1990/12/26Control Supplement
017463087AP1989/07/25Manufacturing Change or Addition
017463085AP1994/06/22Control Supplement
017463082AP1990/10/02Control Supplement
017463079AP1988/02/16Labeling Revision
017463078AP1988/02/16Labeling Revision
017463077AP1988/02/16Labeling Revision
017463075AP1987/11/27Labeling Revision
017463074AP1986/12/16Manufacturing Change or Addition
017463072AP1986/10/10Labeling Revision
017463071AP1986/10/10Labeling Revision
017463070AP1986/10/10Package Change
017463069AP1985/11/06Labeling Revision
017463068AP1990/10/31Formulation Revision
017463065AP1986/12/22Formulation Revision
017463063AP1985/05/22Labeling Revision
017463062AP1984/05/29Control Supplement
017463057AP1983/04/09Labeling Revision
017463053AP1985/05/22Labeling Revision
017463052AP1982/03/01Labeling Revision
017463051AP1981/07/02Expiration Date Change
017463050AP1981/07/02Expiration Date Change
017463049AP1982/03/01Labeling Revision
017463048AP1981/03/31Labeling Revision
017463047AP1980/09/12Expiration Date Change
017463046AP1982/03/01Labeling Revision
017463045AP1979/12/21Control Supplement
017463044AP1980/01/31Control Supplement
017463042AP1979/06/20Manufacturing Change or Addition
017463041AP1979/04/16Manufacturing Change or Addition
017463040AP1979/08/21General Efficacy (MarkIV)
017463039AP1979/03/22Package Change
017463038AP1979/02/27Expiration Date Change
017463035AP1978/09/12Package Change
017463034AP1979/02/09Control Supplement
017463032AP1978/08/08Manufacturing Change or Addition
017463031AP1978/02/23Control Supplement
017463030AP1978/04/21Manufacturing Change or Addition
017463029AP1978/02/03Expiration Date Change
017463028AP1977/04/07Supplement
017463024AP1979/08/21Labeling Revision
017463022AP1976/12/14Distributor
017463019AP1976/09/08Manufacturing Change or Addition
017463018AP1976/08/27Labeling Revision
017463017AP1976/05/03
017463016AP1976/03/01Labeling Revision
017463013AP1975/11/12Labeling Revision
017463012AP1975/11/12Control Supplement
017463011AP1975/11/12Labeling Revision
017463010AP1976/05/03Control Supplement
017463008AP1975/11/11Control Supplement
017463000AP1974/09/19Approval