药品名称ZYPREXA ZYDIS
申请号021086产品号001
活性成分OLANZAPINE市场状态处方药
剂型或给药途径TABLET, ORALLY DISINTEGRATING;ORAL规格5MG
治疗等效代码AB参比药物
批准日期2000/04/06申请机构ELI LILLY AND CO
化学类型New dosage form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-964PDF格式
历史专利信息
52293822011/04/23U-324PDF格式
5229382*PED2011/10/23PDF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
PED2007/01/10
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
021086043APLabel2016/10/07下载
021086043APLetter2016/10/14下载
021086042APLabel2015/07/24下载
021086041APLabel2013/07/30下载
021086041APLetter2013/07/30下载
021086040APLetter2014/12/23下载
021086040APLabel2015/01/09下载
021086039APMedication Guide2011/06/29下载
021086039APLetter2011/06/27下载
021086039APLabel2011/06/29下载
021086038APMedication Guide2011/06/29下载
021086038APLabel2011/06/29下载
021086038APLetter2011/06/27下载
021086036APLabel2010/12/04下载
021086036APLetter2010/12/06下载
021086034APMedication Guide2010/06/03下载
021086034APLetter2010/06/03下载
021086034APLabel2010/06/03下载
021086032APMedication Guide2010/06/03下载
021086032APLabel2010/06/03下载
021086032APLetter2010/06/03下载
021086031APLabel2010/01/29下载
021086031APLetter2010/02/01下载
021086030APLabel2009/09/17下载
021086030APLetter2009/11/19下载
021086028APLetter2008/08/19下载
021086023APLetter2007/07/10下载
021086023APLabel2007/07/10下载
021086022APLabel2007/07/10下载
021086022APLetter2007/07/10下载
021086021APLabel2009/03/20下载
021086020APLabel2006/12/04下载
021086020APLetter2006/12/28下载
021086016APLabel2006/02/28下载
021086016APLetter2006/03/01下载
021086015APLetter2005/09/15下载
021086011APLabel2006/08/29下载
021086011APLetter2006/09/18下载
021086000APLetter2000/04/06下载
021086000APLabel2000/04/06下载
021086000APReview2000/04/06下载
021086000APMedication Guide2009/12/04下载
021086000APOther Important Information from FDA2011/12/22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
021086043AP2016/10/06Labeling Revision
021086042AP2015/07/23Labeling Revision
021086041AP2013/07/26Supplement
021086040AP2014/12/19Labeling Revision
021086039AP2011/06/21Labeling Revision
021086038AP2011/06/21Labeling Revision
021086036AP2010/12/01Labeling Revision
021086034AP2010/05/27Labeling Revision
021086032AP2010/05/27Labeling Revision
021086031AP2010/01/27Labeling Revision
021086030AP2009/08/31Labeling Revision
021086028AP2008/08/14Labeling Revision
021086023AP2007/07/06Labeling Revision
021086022AP2007/07/06Labeling Revision
021086021AP2009/03/19Efficacy Supplement with Clinical Data to Support
021086020AP2006/11/29Labeling Revision
021086016AP2006/02/23Labeling Revision
021086015AP2005/09/13Labeling Revision
021086013AP2006/02/16Labeling Revision
021086011AP2006/08/25Labeling Revision
021086009AP2006/02/16Labeling Revision
021086003AP2001/10/24Control Supplement
021086000AP2000/04/06Approval