药品名称PAXIL
申请号020031产品号005
活性成分PAROXETINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 40MG BASE
治疗等效代码AB参比药物
批准日期1992/12/29申请机构APOTEX TECHNOLOGIES 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
61212912017/03/17U-431PDF格式
61212912017/03/17U-286PDF格式
5872132*PED2015/11/19PDF格式
5900423*PED2015/11/19PDF格式
6121291*PED2017/09/17PDF格式
6133289*PED2015/11/19PDF格式
历史专利信息
47217232006/12/29U-12PDF格式
4721723*PED2007/06/29U-12PDF格式
58721322015/05/19PDF格式
59004232015/05/19PDF格式
61139442014/12/14PDF格式
6113944*PED2015/06/14PDF格式
6121291*PED2017/09/17U-286PDF格式
6121291*PED2017/09/17U-431PDF格式
61332892015/05/19U-358PDF格式
6133289*PED2015/11/19U-358PDF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
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
020031071APLetter2014/07/23下载
020031071APLabel2014/07/29下载
020031069APLetter2011/03/24下载
020031069APLabel2011/03/28下载
020031068APLetter2012/04/12下载
020031068APLabel2012/04/17下载
020031067APLetter2012/12/21下载
020031067APLabel2012/12/31下载
020031066APLetter2011/07/12下载
020031066APLabel2011/07/12下载
020031065APLetter2011/03/24下载
020031065APLabel2011/03/28下载
020031063APLabel2010/10/28下载
020031063APLetter2010/11/02下载
020031062APLetter2011/03/24下载
020031062APLabel2011/03/28下载
020031061APLetter2009/02/03下载
020031061APLabel2009/02/04下载
020031060APLetter2008/11/03下载
020031060APLabel2008/11/07下载
020031059APLabel2009/11/05下载
020031059APLetter2009/11/19下载
020031058APLabel2011/07/12下载
020031058APLetter2011/07/12下载
020031055APLetter2006/09/25下载
020031054APLetter2006/09/25下载
020031053APLabel2007/08/03下载
020031053APLetter2007/08/07下载
020031052APLetter2006/02/08下载
020031052APReview2014/01/16下载
020031051APLetter2006/02/08下载
020031049APLetter2006/09/25下载
020031048APLetter2006/02/08下载
020031046APLetter2006/03/23下载
020031045APLetter2005/01/13下载
020031045APLabel2005/01/13下载
020031043APLetter2004/05/27下载
020031042APLetter2005/07/15下载
020031040APLetter2004/04/20下载
020031039APLetter2004/04/20下载
020031035APLetter2002/10/02下载
020031031APReview2007/07/09下载
020031030APReview2007/07/09下载
020031029APLetter2001/12/14下载
020031029APLabel2001/12/14下载
020031029APReview2004/09/15下载
020031028APReview2007/07/09下载
020031027APReview2007/07/09下载
020031026APReview2004/06/29下载
020031026APLetter2001/04/13下载
020031026APLabel2001/04/13下载
020031025APReview2007/07/09下载
020031023APLetter1999/05/11下载
020031023APLabel2003/04/24下载
020031000APOther Important Information from FDA2005/08/16下载
020031000APMedication Guide2009/11/20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
020031071AP2014/07/18Labeling Revision
020031069AP2011/03/21Labeling Revision
020031068AP2012/04/10Labeling Revision
020031067AP2012/12/18Labeling Revision
020031066AP2011/07/08Labeling Revision
020031065AP2011/03/21Labeling Revision
020031063AP2010/10/27Labeling Revision
020031062AP2011/03/21Labeling Revision
020031061AP2009/01/30Labeling Revision
020031060AP2008/10/31Labeling Revision
020031059AP2009/08/07Labeling Revision
020031058AP2011/07/08Labeling Revision
020031055AP2006/08/22Labeling Revision
020031054AP2006/08/22Labeling Revision
020031053AP2007/08/02Labeling Revision
020031052AP2006/02/06Labeling Revision
020031051AP2006/02/06Labeling Revision
020031049AP2006/08/22Labeling Revision
020031048AP2006/02/06Labeling Revision
020031046AP2006/03/09Labeling Revision
020031045AP2005/01/12Labeling Revision
020031043AP2004/05/21Supplement
020031042AP2005/07/13Labeling Revision
020031040AP2004/04/08Labeling Revision
020031039AP2004/04/08Labeling Revision
020031035AP2002/10/02Efficacy Supplement with Clinical Data to Support
020031034AP2001/04/30Manufacturing Change or Addition
020031033AP2001/05/22Package Change
020031032AP2001/04/30Manufacturing Change or Addition
020031031AP2001/02/15Labeling Revision
020031030AP2000/09/28Labeling Revision
020031029AP2001/12/14New or Modified Indication
020031028AP2000/09/21Control Supplement
020031027AP2000/09/20Manufacturing Change or Addition
020031026AP2001/04/13New or Modified Indication
020031025AP2000/05/17Manufacturing Change or Addition
020031023AP1999/05/11New or Modified Indication
020031022AP1998/02/19Control Supplement
020031021AP1998/02/19Control Supplement
020031020AP1997/12/16Manufacturing Change or Addition
020031019AP1997/07/22Control Supplement
020031018AP1997/07/14Control Supplement
020031017AP1997/05/19Labeling Revision
020031016AP1996/12/13Control Supplement
020031015AP1996/10/17Labeling Revision
020031013AP1997/06/24Formulation Revision
020031012AP1996/07/11Control Supplement
020031011AP1996/07/02Control Supplement
020031010AP1996/03/05Control Supplement
020031009AP1996/05/07New or Modified Indication
020031008AP1995/02/23Labeling Revision
020031007AP1996/05/07New or Modified Indication
020031006AP1995/05/10Manufacturing Change or Addition
020031005AP1995/02/23Labeling Revision
020031004AP1994/09/22Formulation Revision
020031003AP1995/02/23Labeling Revision
020031002AP1994/06/22Expiration Date Change
020031001AP1994/11/29Control Supplement
020031000AP1992/12/29Approval