药品名称RISPERDAL
申请号020272产品号004
活性成分RISPERIDONE市场状态处方药
剂型或给药途径TABLET;ORAL规格4MG
治疗等效代码AB参比药物
批准日期1993/12/29申请机构JANSSEN PHARMACEUTICALS 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
48046632007/12/29U-90PDF格式
4804663*PED2008/06/29PDF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
I-4122006/12/04
I-4132006/12/04
I-5092009/10/06
I-5402010/08/22
I-5412010/08/22
PED2007/06/04
PED2010/04/06
PED2011/02/22
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
020272077APLetter2016/03/03下载
020272077APLabel2016/03/03下载
020272073APLabel2014/04/29下载
020272073APLetter2014/05/09下载
020272067APLetter2012/03/13下载
020272066APLetter2011/09/28下载
020272066APLabel2011/09/30下载
020272065APLabel2012/08/03下载
020272065APLetter2012/08/03下载
020272064APLabel2011/06/16下载
020272064APLetter2011/06/17下载
020272063APLabel2010/12/04下载
020272063APLetter2010/12/06下载
020272062APLetter2010/09/07下载
020272062APLabel2010/08/30下载
020272061APLabel2010/08/30下载
020272061APLetter2010/09/07下载
020272060APLabel2011/09/30下载
020272060APLetter2011/09/28下载
020272059APLabel2011/08/25下载
020272059APLetter2011/08/26下载
020272058APLetter2010/09/07下载
020272058APLabel2010/08/30下载
020272056APLabel2009/08/06下载
020272056APLetter2009/08/06下载
020272055APLabel2010/08/30下载
020272055APLetter2010/09/07下载
020272054APLetter2008/08/19下载
020272047APLetter2007/08/22下载
020272047APLabel2007/08/23下载
020272047APReview2011/12/14下载
020272046APReview2011/12/14下载
020272046APLabel2007/08/23下载
020272046APLetter2007/08/22下载
020272042APLetter2005/08/19下载
020272042APLabel2005/08/19下载
020272041APLabel2006/10/11下载
020272041APLetter2006/10/18下载
020272041APReview2013/06/03下载
020272036APReview2013/06/03下载
020272036APLetter2006/10/18下载
020272036APLabel2006/10/11下载
020272035APLetter2003/11/25下载
020272033APLetter2004/06/16下载
020272033APReview2008/02/19下载
020272027APLetter2003/12/11下载
020272027APLabel2003/12/11下载
020272027APReview2009/09/16下载
020272026APLetter2003/12/11下载
020272026APLabel2003/12/11下载
020272026APReview2009/09/16下载
020272025APLetter2003/11/28下载
020272024APLetter2002/11/19下载
020272009APLetter2004/06/16下载
020272009APLabel2004/06/16下载
020272008APLetter2002/03/03下载
020272008APReview2009/01/12下载
020272007APReview1997/10/17下载
020272007APOther2004/11/03下载
020272005APReview2007/07/20下载
020272004APReview2007/07/20下载
020272000APOther Important Information from FDA2011/12/20下载
020272000APReview2011/02/15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
020272077AP2016/03/01Labeling Revision
020272076AP2016/02/09Manufacturing Change or Addition
020272073AP2014/04/28Labeling Revision
020272072AP2013/06/13Manufacturing Change or Addition
020272071AP2013/02/08Manufacturing Change or Addition
020272067AP2012/03/12Labeling Revision
020272066AP2011/09/24Labeling Revision
020272065AP2012/08/02Efficacy Supplement with Clinical Data to Support
020272064AP2011/06/15Labeling Revision
020272063AP2010/12/01Labeling Revision
020272062AP2010/08/30Labeling Revision
020272061AP2010/08/30Labeling Revision
020272060AP2011/09/24Labeling Revision
020272059AP2011/08/24Labeling Revision
020272058AP2010/08/30Labeling Revision
020272056AP2009/07/19Labeling Revision
020272055AP2010/08/30Labeling Revision
020272054AP2008/08/14Labeling Revision
020272047AP2007/08/22Patient Population Altered
020272046AP2007/08/22Patient Population Altered
020272042AP2005/08/17Labeling Revision
020272041AP2006/10/06New or Modified Indication
020272036AP2006/10/06New or Modified Indication
020272035AP2003/11/21Labeling Revision
020272033AP2003/09/10Labeling Revision
020272027AP2003/12/04New or Modified Indication
020272026AP2003/12/04New or Modified Indication
020272025AP2003/10/29Labeling Revision
020272024AP2002/11/19Labeling Revision
020272023AP2002/07/09Expiration Date Change
020272021AP2001/09/28Manufacturing Change or Addition
020272020AP2001/10/22Control Supplement
020272019AP2001/07/20Manufacturing Change or Addition
020272015AP1999/10/27Control Supplement
020272014AP1999/05/10Manufacturing Change or Addition
020272013AP1999/01/27Manufacturing Change or Addition
020272012AP1998/10/26Manufacturing Change or Addition
020272010AP1998/05/13Control Supplement
020272009AP1999/07/02Labeling Revision
020272008AP2002/03/03Efficacy Supplement with Clinical Data to Support
020272007AP1997/10/17New Dosage Regimen
020272006AP1998/04/02Labeling Revision
020272005AP1996/03/07Manufacturing Change or Addition
020272004AP1996/02/28Labeling Revision
020272003AP1995/04/12Labeling Revision
020272002AP1994/12/22Manufacturing Change or Addition
020272001AP1994/08/24Labeling Revision
020272000AP1993/12/29Approval