药品名称ZOLOFT
申请号019839产品号004
活性成分SERTRALINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 200MG BASE
治疗等效代码参比药物
批准日期1991/12/30申请机构PFIZER PHARMACEUTICALS 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
历史专利信息
49621282009/11/02U-152PDF格式
4962128*PED2010/05/02U-152PDF格式
52486992012/08/13PDF格式
5248699*PED2013/02/13PDF格式
57445012009/01/06U-461PDF格式
57894492009/01/06U-460PDF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
019839084APLetter2014/09/16下载
019839084APLabel2014/09/19下载
019839083APLabel2014/07/08下载
019839083APLetter2014/07/08下载
019839081APLetter2012/12/21下载
019839081APLabel2012/12/28下载
019839080APLabel2014/07/08下载
019839080APLetter2014/07/08下载
019839079APLetter2013/02/04下载
019839079APLabel2013/02/06下载
019839076APLetter2011/08/22下载
019839076APLabel2011/08/24下载
019839075APLabel2011/08/24下载
019839075APLetter2011/08/22下载
019839073APLetter2012/12/21下载
019839073APLabel2012/12/28下载
019839072APLabel2011/08/24下载
019839072APLetter2011/08/22下载
019839070APLetter2009/02/03下载
019839070APLabel2009/02/04下载
019839068APLetter2008/03/07下载
019839068APLabel2008/03/07下载
019839065APLetter2007/10/10下载
019839065APLabel2007/10/10下载
019839064APLabel2007/08/03下载
019839064APLetter2007/08/07下载
019839063APLetter2007/08/07下载
019839063APLabel2007/08/03下载
019839060APLetter2006/09/15下载
019839060APLabel2006/09/15下载
019839059APLetter2007/08/07下载
019839058APLabel2006/09/15下载
019839058APLetter2006/09/15下载
019839057APLetter2006/05/16下载
019839055APLetter2005/07/29下载
019839054APLetter2005/02/23下载
019839054APLabel2005/07/14下载
019839053APLabel2005/07/14下载
019839053APLetter2005/02/23下载
019839050APLabel2004/08/25下载
019839050APLetter2004/08/25下载
019839047APLabel2004/08/25下载
019839047APLetter2004/08/25下载
019839045APLetter2004/07/01下载
019839045APLabel2003/03/05下载
019839044APLetter2003/09/25下载
019839044APLabel2003/09/25下载
019839044APReview2007/03/02下载
019839043APLetter2002/09/18下载
019839039APLetter2002/05/16下载
019839039APLabel2002/05/16下载
019839036APLetter2002/09/20下载
019839035APLetter2001/08/17下载
019839035APLabel2001/08/17下载
019839035APReview2001/08/17下载
019839033APLabel2003/04/25下载
019839033APLetter2003/07/31下载
019839026APLetter1999/12/07下载
019839026APLabel1999/12/07下载
019839026APReview1999/12/07下载
019839018APReview1997/10/10下载
019839017APReview1997/10/10下载
019839011APReview1997/07/08下载
019839000APOther Important Information from FDA2005/07/29下载
019839000APMedication 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
019839085AP2014/01/10Manufacturing Change or Addition
019839084AP2014/09/12Labeling Revision
019839083AP2014/07/03Labeling Revision
019839082AP2013/09/26Manufacturing Change or Addition
019839081AP2012/12/18Labeling Revision
019839080AP2014/07/03Labeling Revision
019839079AP2013/02/01Labeling Revision
019839076AP2011/08/19Labeling Revision
019839075AP2011/08/19Labeling Revision
019839073AP2012/12/18Labeling Revision
019839072AP2011/08/19Labeling Revision
019839070AP2009/01/30Labeling Revision
019839068AP2008/03/06Labeling Revision
019839065AP2007/10/04Labeling Revision
019839064AP2007/08/02Labeling Revision
019839063AP2007/08/02Labeling Revision
019839060AP2006/09/14Labeling Revision
019839059AP2007/08/02Labeling Revision
019839058AP2006/09/14Labeling Revision
019839057AP2006/05/04Labeling Revision
019839055AP2005/07/26Labeling Revision
019839054AP2005/02/18Labeling Revision
019839053AP2005/02/18Labeling Revision
019839050AP2004/08/19Labeling Revision
019839047AP2004/08/19Efficacy Supplement with Clinical Data to Support
019839045AP2003/02/07New or Modified Indication
019839044AP2003/09/16Patient Population Altered
019839043AP2002/09/18Labeling Revision
019839042AP2002/01/09Manufacturing Change or Addition
019839040AP2001/07/12Manufacturing Change or Addition
019839039AP2002/05/16New or Modified Indication
019839038AP2000/11/16Labeling Revision
019839037AP2001/02/22Labeling Revision
019839036AP2002/09/20Efficacy Supplement with Clinical Data to Support
019839035AP2001/08/06Efficacy Supplement with Clinical Data to Support
019839034AP2002/09/20Efficacy Supplement with Clinical Data to Support
019839033AP2001/10/12Efficacy Supplement with Clinical Data to Support
019839032AP2000/03/17Manufacturing Change or Addition
019839031AP2000/01/03Package Change
019839030AP1999/10/07Manufacturing Change or Addition
019839029AP1999/10/07Manufacturing Change or Addition
019839027AP2001/02/22Labeling Revision
019839026AP1999/12/07New or Modified Indication
019839024AP1998/04/10Control Supplement
019839023AP1997/12/04Control Supplement
019839020AP1997/04/07Control Supplement
019839018AP1997/10/10Labeling Revision
019839017AP1997/10/10Patient Population Altered
019839012AP1996/03/05Manufacturing Change or Addition
019839011AP1997/07/08New or Modified Indication
019839010AP1996/03/06Control Supplement
019839009AP1995/10/05Manufacturing Change or Addition
019839008AP1995/06/16Labeling Revision
019839007AP1995/03/22Control Supplement
019839006AP1995/06/16Labeling Revision
019839005AP1994/09/07Formulation Revision
019839003AP1995/09/14Labeling Revision
019839002AP1996/10/25New or Modified Indication
019839001AP1992/06/22Manufacturing Change or Addition
019839000AP1991/12/30Approval