药品名称SEROQUEL
申请号020639产品号004
活性成分QUETIAPINE FUMARATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1998/12/20申请机构ASTRAZENECA PHARMACEUTICALS LP
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
48792882011/09/26YYU-550PDF格式
4879288*PED2012/03/26PDF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
I-4182007/01/12
I-4192007/01/12
I-5032009/10/20
I-5602011/05/13
PED2010/04/20
PED2011/11/13
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
020639064APLetter2016/06/21下载
020639064APLabel2016/06/21下载
020639061APLetter2013/10/30下载
020639061APLabel2013/10/31下载
020639059APLetter2013/05/02下载
020639059APLabel2013/05/01下载
020639058APLabel2013/05/01下载
020639058APLetter2013/05/02下载
020639057APLetter2013/05/02下载
020639057APLabel2013/05/01下载
020639055APMedication Guide2011/11/10下载
020639055APLetter2011/11/14下载
020639054APMedication Guide2011/07/12下载
020639054APReview2012/03/07下载
020639054APLetter2011/07/12下载
020639054APLabel2011/07/12下载
020639053APLabel2013/05/01下载
020639053APLetter2013/05/02下载
020639052APLabel2010/12/04下载
020639052APLetter2010/12/06下载
020639051APLetter2011/05/19下载
020639051APLabel2011/05/23下载
020639049APLetter2011/07/12下载
020639049APMedication Guide2011/07/12下载
020639049APLabel2011/07/12下载
020639049APReview2012/03/07下载
020639046APLabel2009/12/11下载
020639046APLetter2010/01/27下载
020639045APLabel2009/12/11下载
020639045APLetter2010/01/27下载
020639043APLetter2008/08/19下载
020639040APLetter2008/05/14下载
020639040APLabel2008/06/05下载
020639039APLetter2008/01/30下载
020639038APLabel2008/06/05下载
020639038APLetter2008/05/14下载
020639037APSummary Review2008/07/16下载
020639037APLabel2008/06/05下载
020639037APLetter2008/05/14下载
020639037APReview2011/09/22下载
020639035APLetter2007/08/02下载
020639031APLetter2008/01/30下载
020639030APLetter2008/10/28下载
020639026APLabel2006/10/23下载
020639026APLetter2006/10/23下载
020639025APLetter2008/05/14下载
020639025APLabel2008/06/05下载
020639023APLabel2006/09/21下载
020639023APLetter2006/09/25下载
020639021APLetter2006/02/08下载
020639020APLetter2004/07/21下载
020639020APLabel2004/07/21下载
020639017APLabel2004/01/15下载
020639017APLetter2004/01/14下载
020639017APReview2007/11/19下载
020639016APReview2007/11/19下载
020639016APLabel2004/01/15下载
020639016APLetter2004/01/14下载
020639011APLetter2001/03/27下载
020639000APOther Important Information from FDA2007/05/09下载
020639000APReview2007/07/17下载
020639000APMedication Guide2009/11/20下载
020639000APOther2011/12/22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
020639064AP2016/06/17Labeling Revision
020639061AP2013/10/29Labeling Revision
020639059AP2013/04/30Labeling Revision
020639058AP2013/04/30Labeling Revision
020639057AP2013/04/30Efficacy Supplement with Clinical Data to Support
020639055AP2011/11/09Labeling Revision
020639054AP2011/07/08Labeling Revision
020639053AP2013/04/30Labeling Revision
020639052AP2010/12/01Labeling Revision
020639051AP2011/05/17Labeling Revision
020639049AP2011/07/08Labeling Revision
020639046AP2009/12/02Patient Population Altered
020639045AP2009/12/02Patient Population Altered
020639043AP2008/08/14Labeling Revision
020639040AP2008/05/13Labeling Revision
020639039AP2008/01/28Labeling Revision
020639038AP2008/05/13Labeling Revision
020639037AP2008/05/13New or Modified Indication
020639035AP2007/07/30Labeling Revision
020639031AP2008/01/28Labeling Revision
020639030AP2008/10/24Packaging Addition
020639026AP2006/10/20New or Modified Indication
020639025AP2008/05/13Labeling Revision
020639023AP2006/09/20Labeling Revision
020639021AP2006/02/07Manufacturing Change or Addition
020639020AP2004/07/21Labeling Revision
020639017AP2004/01/12New or Modified Indication
020639016AP2004/01/12New or Modified Indication
020639015AP2002/12/06Manufacturing Change or Addition
020639013AP2001/11/16Manufacturing Change or Addition
020639012AP2001/03/19Package Change
020639011AP2001/03/27Labeling Revision
020639010AP2000/11/06Manufacturing Change or Addition
020639009AP2001/01/24Manufacturing Change or Addition
020639008AP2000/07/07Manufacturing Change or Addition
020639007AP2000/07/26Manufacturing Change or Addition
020639003AP1998/12/20Manufacturing Change or Addition
020639002AP1998/05/08Manufacturing Change or Addition
020639001AP1998/02/23Manufacturing Change or Addition
020639000AP1997/09/26Approval