药品名称PREVACID
申请号020406产品号001
活性成分LANSOPRAZOLE市场状态处方药
剂型或给药途径CAPSULE, DELAYED REL PELLETS;ORAL规格15MG
治疗等效代码AB参比药物
批准日期1995/05/10申请机构TAKEDA PHARMACEUTICALS USA 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
46280982009/05/10PDF格式
4628098*PED2009/11/10PDF格式
50137432010/02/12U-452PDF格式
5013743*PED2010/08/12PDF格式
50265602008/06/25PDF格式
5026560*PED2008/12/25PDF格式
50453212008/09/03PDF格式
5045321*PED2009/03/03PDF格式
50931322008/09/03PDF格式
5093132*PED2009/03/03PDF格式
54339592008/09/03PDF格式
5433959*PED2009/03/03PDF格式
67498642007/02/13YPDF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
NPP2007/06/17
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
020406082APLetter2016/10/26下载
020406082APLabel2016/10/31下载
020406081APLetter2014/12/24下载
020406081APLabel2014/12/29下载
020406080APLabel2015/12/17下载
020406080APLetter2015/12/18下载
020406079APLabel2012/05/07下载
020406079APLetter2012/05/09下载
020406078APLabel2012/10/01下载
020406078APLetter2012/10/02下载
020406077APLetter2011/05/25下载
020406077APLabel2011/05/26下载
020406076APLetter2011/10/31下载
020406076APLabel2011/11/01下载
020406075APLetter2011/06/03下载
020406075APLabel2011/06/07下载
020406074APLetter2010/09/09下载
020406074APLabel2010/09/10下载
020406073APLetter2010/05/17下载
020406073APLabel2010/05/17下载
020406071APLetter2009/11/12下载
020406071APLabel2009/08/13下载
020406067APLetter2008/10/29下载
020406067APLabel2008/11/07下载
020406065APLetter2008/04/23下载
020406064APLabel2007/06/27下载
020406064APLetter2007/07/05下载
020406058APLabel2006/04/13下载
020406058APLetter2006/04/13下载
020406057APLabel2004/12/21下载
020406057APLetter2004/06/23下载
020406056APLetter2004/06/16下载
020406056APLabel2004/06/16下载
020406055APLetter2003/08/15下载
020406052APReview2005/06/23下载
020406052APLetter2002/08/30下载
020406052APLabel2002/08/30下载
020406048APLetter2002/12/03下载
020406048APReview2007/11/19下载
020406047APLetter2002/07/31下载
020406047APLabel2002/07/31下载
020406045APLetter2002/05/03下载
020406045APLabel2002/05/03下载
020406044APReview2009/09/16下载
020406043APReview2009/09/16下载
020406041APReview2009/09/16下载
020406039APReview2009/09/16下载
020406038APLabel2003/04/24下载
020406038APLetter2003/07/31下载
020406035APReview2009/09/16下载
020406034APReview2000/06/20下载
020406033APLetter2000/11/30下载
020406033APLabel2000/11/30下载
020406030APReview1999/02/22下载
020406028APLetter1999/07/06下载
020406028APReview1999/07/06下载
020406027APReview1999/01/14下载
020406026APReview2009/09/16下载
020406025APReview2009/09/16下载
020406024APReview2009/09/16下载
020406023APReview2009/09/16下载
020406022APLetter1998/07/20下载
020406022APReview1998/07/20下载
020406021APLetter1998/07/20下载
020406021APReview1998/07/20下载
020406020APReview2009/09/16下载
020406019APReview2009/09/16下载
020406018APReview2009/09/16下载
020406017APReview2011/12/09下载
020406016APReview1998/03/12下载
020406009APReview2009/09/16下载
020406007APReview2009/09/16下载
020406006APReview2009/09/16下载
020406005APReview2009/09/16下载
020406004APReview2009/09/16下载
020406000APOther Important Information from FDA2011/12/20下载
020406000APMedication Guide2012/10/03下载
020406000APReview2010/03/16下载
020406000APLabel2016/04/20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
020406082AP2016/10/24Labeling Revision
020406081AP2014/12/19Labeling Revision
020406080AP2015/12/16Labeling Revision
020406079AP2012/05/03Labeling Revision
020406078AP2012/09/28Labeling Revision
020406077AP2011/05/20Labeling Revision
020406076AP2011/10/28Labeling Revision
020406075AP2011/06/01Labeling Revision
020406074AP2010/09/03Labeling Revision
020406073AP2010/05/12Labeling Revision
020406071AP2009/07/31Labeling Revision
020406067AP2008/10/28Labeling Revision
020406065AP2008/04/21Labeling Revision
020406064AP2007/06/14Labeling Revision
020406058AP2006/04/12Labeling Revision
020406057AP2004/06/17Patient Population Altered
020406056AP2004/06/15Labeling Revision
020406055AP2003/08/05Labeling Revision
020406052AP2002/08/30Labeling Revision
020406048AP2002/12/03Labeling Revision
020406047AP2002/07/31Patient Population Altered
020406046AP2002/03/07Control Supplement
020406045AP2002/05/03Labeling Revision
020406044AP2001/12/05Manufacturing Change or Addition
020406043AP2001/04/11Package Change
020406042AP2000/12/08Control Supplement
020406041AP2001/06/29Package Change
020406040AP2001/05/07Manufacturing Change or Addition
020406039AP2000/10/30Package Change
020406038AP2001/05/01Efficacy Supplement with Clinical Data to Support
020406036AP1999/11/15Control Supplement
020406035AP2000/06/02Manufacturing Change or Addition
020406034AP2000/06/20Labeling Revision
020406033AP2000/11/30New or Modified Indication
020406032AP1999/11/15Manufacturing Change or Addition
020406030AP1999/02/22Labeling Revision
020406029AP1998/11/20Control Supplement
020406028AP1999/07/06Comparative Efficacy Claim
020406027AP1999/01/14Labeling Revision
020406026AP1998/03/19Package Change
020406025AP1998/07/27Package Change
020406024AP1998/06/23Labeling Revision
020406023AP1998/06/11Package Change
020406022AP1998/07/20Labeling Revision
020406021AP1998/07/20New Dosage Regimen
020406020AP1997/09/04Manufacturing Change or Addition
020406019AP1997/09/17Manufacturing Change or Addition
020406018AP1997/06/23Labeling Revision
020406017AP1997/09/17Manufacturing Change or Addition
020406016AP1998/03/12New or Modified Indication
020406015AP1997/06/17Labeling Revision
020406013AP1997/06/17Labeling Revision
020406012AP1996/12/24Labeling Revision
020406011AP1997/05/08New or Modified Indication
020406010AP1997/04/17New or Modified Indication
020406009AP1997/02/25Labeling Revision
020406008AP1996/09/13Package Change
020406007AP1996/07/25Package Change
020406006AP1996/01/30Labeling Revision
020406005AP1996/05/06Package Change
020406004AP1995/10/18Labeling Revision
020406002AP1996/04/08New or Modified Indication
020406001AP1995/11/30Labeling Revision
020406000AP1995/05/10Approval