药品名称PROZAC
申请号018936产品号006
活性成分FLUOXETINE HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格EQ 10MG BASE
治疗等效代码AB1参比药物
批准日期1992/12/23申请机构ELI LILLY AND CO
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
69605772017/11/01U-963PDF格式
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
NPP2016/07/26
历史市场独占权保护信息
PED2006/07/03
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
018936106APLetter2015/11/25下载
018936105APLabel2014/07/23下载
018936105APLetter2014/07/24下载
018936102APLetter2014/10/15下载
018936102APLabel2014/10/15下载
018936101APLabel2013/07/30下载
018936101APLetter2013/07/30下载
018936100APLetter2013/07/30下载
018936100APLabel2013/07/30下载
018936098APLetter2013/01/07下载
018936098APMedication Guide2013/01/07下载
018936098APLabel2013/01/07下载
018936097APLetter2013/01/07下载
018936097APLabel2013/01/07下载
018936097APMedication Guide2013/01/07下载
018936097APReview2015/11/18下载
018936096APLetter2011/06/16下载
018936096APLabel2011/06/16下载
018936095APMedication Guide2011/06/15下载
018936095APLabel2011/04/04下载
018936095APLetter2011/04/13下载
018936093APLetter2011/04/13下载
018936093APMedication Guide2011/06/15下载
018936093APLabel2011/04/04下载
018936093APReview2013/10/21下载
018936091APLabel2011/04/04下载
018936091APLetter2011/04/13下载
018936091APMedication Guide2011/06/15下载
018936089APLetter2009/06/24下载
018936089APLabel2009/06/24下载
018936088APLetter2009/02/03下载
018936088APLabel2009/02/04下载
018936086APLabel2008/06/30下载
018936086APLetter2008/07/01下载
018936084APLabel2008/03/24下载
018936084APLetter2008/03/24下载
018936083APLetter2008/03/12下载
018936083APLabel2008/03/13下载
018936082APLabel2007/08/03下载
018936082APLetter2007/08/07下载
018936081APLetter2007/08/07下载
018936081APLabel2007/08/03下载
018936078APLetter2007/03/23下载
018936078APReview2015/11/05下载
018936077APLabel2009/03/20下载
018936077APLetter2009/03/24下载
018936076APLabel2006/09/21下载
018936075APLetter2009/03/24下载
018936075APLabel2009/03/20下载
018936074APLetter2006/04/13下载
018936073APLetter2005/12/05下载
018936072APLetter2005/02/23下载
018936071APLetter2005/12/05下载
018936070APLetter2004/09/03下载
018936069APLetter2004/08/25下载
018936067APLetter2002/06/12下载
018936067APLabel2002/06/12下载
018936064APLetter2003/01/07下载
018936064APReview2003/09/25下载
018936064APLabel2003/01/07下载
018936063APReview2007/02/20下载
018936062APReview2007/02/20下载
018936061APLabel2002/07/29下载
018936060APReview2007/02/20下载
018936058APLetter2000/07/06下载
018936058APLabel2000/07/06下载
018936054APReview2004/08/09下载
018936052APReview2004/08/09下载
018936036APReview2003/09/25下载
018936033APReview2007/12/06下载
018936000APOther Important Information from FDA2005/08/01下载
018936000APMedication 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
018936107AP2016/08/01Manufacturing Change or Addition
018936106AP2015/11/24Labeling Revision
018936105AP2014/07/18Labeling Revision
018936102AP2014/10/10Efficacy Supplement with Clinical Data to Support
018936101AP2013/07/26Supplement
018936100AP2013/07/26Labeling Revision
018936098AP2013/01/03Labeling Revision
018936097AP2013/01/03Labeling Revision
018936096AP2011/06/15Labeling Revision
018936095AP2011/04/04Labeling Revision
018936093AP2011/04/04Labeling Revision
018936091AP2011/04/04Labeling Revision
018936089AP2009/06/22Labeling Revision
018936088AP2009/01/30Labeling Revision
018936086AP2008/06/26Labeling Revision
018936084AP2008/03/21Labeling Revision
018936083AP2008/03/09Labeling Revision
018936082AP2007/08/02Labeling Revision
018936081AP2007/08/02Labeling Revision
018936078AP2007/03/15Labeling Revision
018936077AP2009/03/19Efficacy Supplement with Clinical Data to Support
018936076AP2006/09/20Labeling Revision
018936075AP2009/03/19Labeling Revision
018936074AP2006/04/11Labeling Revision
018936073AP2005/12/01Labeling Revision
018936072AP2005/02/18Labeling Revision
018936071AP2005/12/01Labeling Revision
018936070AP2004/09/03Labeling Revision
018936069AP2004/08/19Labeling Revision
018936067AP2002/06/12New Dosage Regimen
018936065AP2002/07/29Efficacy Supplement with Clinical Data to Support
018936064AP2003/01/03Patient Population Altered
018936063AP2000/11/28Labeling Revision
018936062AP2000/11/28Labeling Revision
018936060AP2000/11/28Labeling Revision
018936059AP1999/06/16Labeling Revision
018936058AP2000/07/06New or Modified Indication
018936057AP1999/02/11Manufacturing Change or Addition
018936056AP1998/10/20Control Supplement
018936054AP1999/06/15Formulation Revision
018936053AP1998/05/29Manufacturing Change or Addition
018936052AP1999/10/07Labeling Revision
018936051AP1998/03/13Labeling Revision
018936050AP1998/07/06Manufacturing Change or Addition
018936049AP1998/04/03Package Change
018936046AP1997/09/17Control Supplement
018936043AP1996/12/30Manufacturing Change or Addition
018936040AP1995/09/12Labeling Revision
018936039AP1995/03/01Control Supplement
018936038AP1995/09/12Labeling Revision
018936037AP1995/03/01Labeling Revision
018936036AP1997/03/25Labeling Revision
018936034AP1994/07/06Labeling Revision
018936033AP1995/01/09Manufacturing Change or Addition
018936032AP1993/03/25Labeling Revision
018936031AP1993/08/18Labeling Revision
018936030AP1992/08/20Labeling Revision
018936028AP1992/01/21Labeling Revision
018936027AP1992/01/21Labeling Revision
018936026AP1992/12/23Formulation Revision
018936025AP1992/01/21Labeling Revision
018936024AP1991/04/09Labeling Revision
018936023AP1991/04/09Labeling Revision
018936022AP1990/06/07Labeling Revision
018936021AP1990/06/07Labeling Revision
018936020AP1990/06/07Labeling Revision
018936019AP1990/06/07Labeling Revision
018936018AP1990/06/07Labeling Revision
018936017AP1990/06/07Labeling Revision
018936016AP1990/06/07Labeling Revision
018936015AP1990/06/07Labeling Revision
018936014AP1989/02/08Control Supplement
018936013AP1989/02/16Labeling Revision
018936012AP1989/02/17Control Supplement
018936011AP1988/11/17Labeling Revision
018936009AP1988/11/17Labeling Revision
018936008AP1988/10/26Manufacturing Change or Addition
018936007AP1988/06/22Labeling Revision
018936006AP1988/09/28Package Change
018936004AP1996/11/21New or Modified Indication
018936003AP1988/09/28Control Supplement
018936002AP1988/05/06Control Supplement
018936000AP1987/12/29Approval