药品名称ZYPREXA
申请号020592产品号004
活性成分OLANZAPINE市场状态处方药
剂型或给药途径TABLET;ORAL规格10MG
治疗等效代码AB参比药物
批准日期1996/09/30申请机构ELI LILLY AND CO
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
69605772017/11/01U-963PDF格式
历史专利信息
52293822011/04/23YYU-149PDF格式
52293822011/04/23YYU-547PDF格式
5229382*PED2011/10/23PDF格式
56058972014/02/25U-176PDF格式
5605897*PED2014/08/25PDF格式
56271782011/04/23U-364PDF格式
5627178*PED2011/10/23PDF格式
57365412015/03/24U-307PDF格式
5736541*PED2015/09/24PDF格式
58176552011/04/23U-364PDF格式
5817655*PED2011/10/23PDF格式
58176562011/04/23U-360PDF格式
5817656*PED2011/10/23PDF格式
58176572011/04/23U-363PDF格式
5817657*PED2011/10/23PDF格式
59194852015/03/24U-308PDF格式
5919485*PED2015/09/24PDF格式
62518952017/09/23PDF格式
6251895*PED2018/03/23PDF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
NPP2016/07/26
历史市场独占权保护信息
I-4002006/07/10
I-4172007/01/14
PED2007/07/14
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
020592067APLabel2016/10/07下载
020592067APLetter2016/10/14下载
020592064APLabel2015/07/24下载
020592063APLabel2013/07/30下载
020592063APLetter2013/07/30下载
020592062APLetter2014/12/23下载
020592062APLabel2015/01/09下载
020592061APLetter2011/06/27下载
020592061APLabel2011/06/29下载
020592061APMedication Guide2011/06/29下载
020592060APMedication Guide2011/06/29下载
020592060APLabel2011/06/29下载
020592060APLetter2011/06/27下载
020592057APLabel2010/12/04下载
020592057APLetter2010/12/06下载
020592055APLetter2010/06/03下载
020592055APLabel2010/06/03下载
020592055APMedication Guide2010/06/03下载
020592055APReview2012/03/16下载
020592053APReview2012/03/16下载
020592053APLetter2010/06/03下载
020592053APMedication Guide2010/06/03下载
020592053APLabel2010/06/03下载
020592052APLabel2010/01/29下载
020592052APLetter2010/02/01下载
020592051APLabel2009/09/17下载
020592051APLetter2009/11/19下载
020592049APLetter2008/08/19下载
020592049APReview2012/01/27下载
020592043APLabel2007/07/10下载
020592043APLetter2007/07/10下载
020592042APLabel2007/07/10下载
020592042APLetter2007/07/10下载
020592041APLabel2009/12/10下载
020592041APLetter2010/01/26下载
020592041APReview2011/06/30下载
020592040APReview2011/06/30下载
020592040APLabel2009/12/10下载
020592040APLetter2010/01/26下载
020592039APLabel2009/03/20下载
020592039APReview2012/03/16下载
020592038APLabel2006/12/04下载
020592038APLetter2006/12/28下载
020592035APLabel2006/02/28下载
020592035APLetter2006/03/01下载
020592035APReview2012/03/16下载
020592034APLetter2005/09/15下载
020592034APReview2009/09/16下载
020592032APLetter2006/02/22下载
020592032APLabel2006/02/22下载
020592029APLabel2006/08/29下载
020592029APLetter2006/09/18下载
020592027APLetter2006/02/22下载
020592027APLabel2006/02/22下载
020592026APLetter2005/08/08下载
020592020APLetter2005/06/29下载
020592019APLetter2004/01/22下载
020592019APLabel2004/01/22下载
020592019APReview2009/09/16下载
020592018APReview2007/07/06下载
020592018APLabel2003/07/10下载
020592018APLetter2003/07/28下载
020592011APReview2004/04/15下载
020592006APReview2007/04/11下载
020592006APOther2011/01/07下载
020592000APOther Important Information from FDA2011/12/22下载
020592000APReview2007/11/19下载
020592000APMedication 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
020592067AP2016/10/06Labeling Revision
020592066AP2013/10/25Manufacturing Change or Addition
020592065AP2013/10/21Manufacturing Change or Addition
020592064AP2015/07/23Labeling Revision
020592063AP2013/07/26Supplement
020592062AP2014/12/19Labeling Revision
020592061AP2011/06/21Labeling Revision
020592060AP2011/06/21Labeling Revision
020592057AP2010/12/01Labeling Revision
020592055AP2010/05/27Labeling Revision
020592053AP2010/05/27Labeling Revision
020592052AP2010/01/27Labeling Revision
020592051AP2009/08/31Labeling Revision
020592049AP2008/08/14Labeling Revision
020592043AP2007/07/06Labeling Revision
020592042AP2007/07/06Labeling Revision
020592041AP2009/12/04Patient Population Altered
020592040AP2009/12/04Patient Population Altered
020592039AP2009/03/19Efficacy Supplement with Clinical Data to Support
020592038AP2006/11/29Labeling Revision
020592035AP2006/02/23Labeling Revision
020592034AP2005/09/13Labeling Revision
020592032AP2006/02/16Labeling Revision
020592029AP2006/08/25Labeling Revision
020592027AP2006/02/16Labeling Revision
020592026AP2005/08/03Labeling Revision
020592020AP2005/06/29Labeling Revision
020592019AP2004/01/14New or Modified Indication
020592018AP2003/07/10New or Modified Indication
020592016AP2002/01/22Package Change
020592014AP2001/03/13Control Supplement
020592011AP2000/11/09New or Modified Indication
020592010AP1999/01/11Labeling Revision
020592007AP1998/03/23Manufacturing Change or Addition
020592006AP2000/03/17New or Modified Indication
020592005AP1997/12/04Control Supplement
020592004AP1997/09/09Manufacturing Change or Addition
020592003AP1997/04/18Manufacturing Change or Addition
020592001AP1997/02/19Manufacturing Change or Addition
020592000AP1996/09/30Approval