药品名称PRILOSEC
申请号019810产品号001
活性成分OMEPRAZOLE市场状态停止上市
剂型或给药途径CAPSULE, DELAYED REL PELLETS;ORAL规格20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1989/09/14申请机构ASTRAZENECA PHARMACEUTICALS LP
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
61662132018/10/09PDF格式
61471032018/10/09PDF格式
61911482018/10/09PDF格式
61503802018/11/10PDF格式
6147103*PED2019/04/09PDF格式
6150380*PED2019/05/10PDF格式
6166213*PED2019/04/09PDF格式
6191148*PED2019/04/09PDF格式
历史专利信息
47865052007/04/20U-108PDF格式
4786505*PED2007/10/20U-108PDF格式
48532302007/04/20U-108PDF格式
4853230*PED2007/10/20U-108PDF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
019810103APLetter2016/10/26下载
019810103APLabel2016/10/31下载
019810101APLetter2014/12/24下载
019810101APLabel2014/12/29下载
019810099APLetter2014/02/27下载
019810099APLabel2014/02/27下载
019810098APLabel2014/04/01下载
019810098APLetter2014/04/14下载
019810097APLetter2013/05/16下载
019810097APLabel2013/05/21下载
019810096APLabel2012/10/01下载
019810096APLetter2012/10/02下载
019810095APLetter2012/10/11下载
019810095APMedication Guide2012/10/12下载
019810095APLabel2012/10/12下载
019810094APLetter2012/01/24下载
019810094APLabel2012/02/06下载
019810093APLetter2011/05/25下载
019810093APLabel2011/05/25下载
019810092APLabel2011/01/24下载
019810092APLetter2011/01/25下载
019810091APLetter2011/07/06下载
019810091APLabel2011/07/06下载
019810090APLetter2010/09/08下载
019810090APLabel2010/09/10下载
019810088APLabel2010/03/05下载
019810088APLetter2010/03/08下载
019810087APLetter2008/12/04下载
019810087APLabel2008/12/04下载
019810085APLabel2007/05/01下载
019810085APLetter2007/05/01下载
019810084APLabel2006/09/26下载
019810084APLetter2006/09/27下载
019810083APLabel2006/01/27下载
019810083APLetter2006/01/30下载
019810082APLetter2005/03/10下载
019810082APLabel2005/03/10下载
019810080APLetter2003/10/16下载
019810080APLabel2003/10/16下载
019810076APLetter2002/12/16下载
019810074APLetter2002/07/12下载
019810074APLabel2002/07/12下载
019810067APLabel2003/10/16下载
019810067APLetter2003/10/16下载
019810062APReview2000/02/23下载
019810061APLetter2002/02/14下载
019810058APLetter2004/03/02下载
019810058APLabel2004/04/05下载
019810058APReview2007/07/20下载
019810057APReview1999/02/03下载
019810056APReview1998/07/10下载
019810050APReview1998/01/07下载
019810038APReview1998/01/15下载
019810036APReview1997/11/04下载
019810008APReview2007/07/09下载
019810003APReview2007/07/20下载
019810003APLabel2004/04/05下载
019810003APLetter2004/03/02下载
019810000APOther Important Information from FDA2011/12/20下载
019810000APMedication Guide2012/10/03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
019810103AP2016/10/24Labeling Revision
019810101AP2014/12/19Labeling Revision
019810099AP2014/02/25Labeling Revision
019810098AP2014/03/27Labeling Revision
019810097AP2013/05/15Labeling Revision
019810096AP2012/09/28Labeling Revision
019810095AP2012/10/09Labeling Revision
019810094AP2012/01/20Labeling Revision
019810093AP2011/05/20Labeling Revision
019810092AP2011/01/20Labeling Revision
019810091AP2011/06/30Labeling Revision
019810090AP2010/09/03Labeling Revision
019810088AP2010/03/03Labeling Revision
019810087AP2008/12/01Labeling Revision
019810085AP2007/04/27Labeling Revision
019810084AP2006/09/25Labeling Revision
019810083AP2006/01/26Labeling Revision
019810082AP2005/03/07Labeling Revision
019810080AP2003/10/09Labeling Revision
019810077AP2002/12/19Control Supplement
019810076AP2002/12/16Labeling Revision
019810075AP2001/05/10Package Change
019810074AP2002/07/12Patient Population Altered
019810073AP2001/10/30Labeling Revision
019810072AP2000/08/10Control Supplement
019810071AP2002/02/04Package Change
019810070AP2000/07/27Expiration Date Change
019810069AP2000/07/27Control Supplement
019810068AP2000/03/13Control Supplement
019810067AP2003/10/09Labeling Revision
019810066AP2001/05/16Package Change
019810065AP1999/11/10Manufacturing Change or Addition
019810064AP2000/03/16Manufacturing Change or Addition
019810063AP2000/08/08Manufacturing Change or Addition
019810062AP2000/02/23Labeling Revision
019810061AP2002/02/14Efficacy Supplement with Clinical Data to Support
019810060AP1999/05/18Control Supplement
019810059AP2000/03/13Expiration Date Change
019810058AP2004/02/23Efficacy Supplement with Clinical Data to Support
019810057AP1999/02/03Labeling Revision
019810056AP1998/07/10Package Change
019810055AP1998/06/30Efficacy Supplement with Clinical Data to Support
019810054AP1998/12/01Control Supplement
019810053AP1998/08/17Package Change
019810052AP1998/07/30Manufacturing Change or Addition
019810051AP1997/06/17Control Supplement
019810050AP1998/01/07Package Change
019810049AP1997/09/03Manufacturing Change or Addition
019810048AP1997/04/15Labeling Revision
019810045AP1999/02/18Control Supplement
019810043AP1997/04/04Manufacturing Change or Addition
019810042AP1997/04/18Manufacturing Change or Addition
019810041AP1996/08/09Labeling Revision
019810039AP1996/09/11Control Supplement
019810038AP1998/01/15Formulation Revision
019810037AP1996/04/15New or Modified Indication
019810036AP1996/11/26New or Modified Indication
019810035AP1995/03/09Labeling Revision
019810034AP1995/11/09Manufacturing Change or Addition
019810033AP1996/03/22New or Modified Indication
019810032AP1995/03/23Control Supplement
019810031AP1995/03/23Manufacturing Change or Addition
019810030AP1995/01/31Manufacturing Change or Addition
019810029AP1995/01/27Control Supplement
019810028AP1995/01/20Formulation Revision
019810026AP1994/12/29Package Change
019810025AP1995/10/19Package Change
019810024AP1995/06/16Labeling Revision
019810023AP1995/10/05Formulation Revision
019810022AP1995/03/09Labeling Revision
019810021AP1993/12/22Package Change
019810020AP1994/10/13Manufacturing Change or Addition
019810019AP1995/06/22New or Modified Indication
019810018AP1997/11/04Labeling Revision
019810016AP1993/06/29Package Change
019810015AP1993/06/15Manufacturing Change or Addition
019810014AP1992/10/21Package Change
019810013AP1993/03/19Control Supplement
019810012AP1993/05/26Manufacturing Change or Addition
019810010AP1995/03/09Labeling Revision
019810009AP1995/03/09Labeling Revision
019810008AP1992/01/27Manufacturing Change or Addition
019810007AP1991/01/03Labeling Revision
019810006AP1990/07/19Labeling Revision
019810005AP1992/09/14Manufacturing Change or Addition
019810003AP2004/02/23Labeling Revision
019810002AP1991/06/12New or Modified Indication
019810001AP1989/10/26Labeling Revision
019810000AP1989/09/14Approval