药品注册申请号:021520
申请类型:NDA (新药申请)
申请人:LILLY
申请人全名:ELI LILLY AND CO
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 3MG BASE Yes No AB 2003/12/24 2007/04/09 Prescription
002 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE Yes No AB 2003/12/24 Prescription
003 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE Yes Yes AB 2003/12/24 Prescription
004 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE Yes No AB 2003/12/24 Prescription
005 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE Yes No AB 2003/12/24 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2018/03/27 SUPPL 50 Approval Labeling STANDARD
2017/03/24 SUPPL 42 Approval Labeling STANDARD
2017/02/23 SUPPL 49 Approval Labeling STANDARD
2017/02/23 SUPPL 48 Approval Labeling 901 REQUIRED
2017/01/04 SUPPL 47 Approval Labeling 901 REQUIRED
2016/10/06 SUPPL 46 Approval Labeling 901 REQUIRED
2014/12/19 SUPPL 34 Approval Labeling STANDARD
2014/10/30 SUPPL 43 Approval Manufacturing (CMC) PRIORITY
2014/10/10 SUPPL 41 Approval Efficacy STANDARD
2014/07/18 SUPPL 45 Approval Labeling 901 REQUIRED
2013/08/07 SUPPL 40 Approval Labeling STANDARD
2013/07/26 SUPPL 39 Approval Efficacy STANDARD
2013/07/26 SUPPL 37 Approval Labeling UNKNOWN
2013/01/03 SUPPL 36 Approval Labeling STANDARD
2013/01/03 SUPPL 35 Approval Labeling STANDARD
2012/08/08 SUPPL 38 Approval Labeling STANDARD
2011/10/04 SUPPL 33 Approval Labeling UNKNOWN
2011/06/21 SUPPL 32 Approval REMS N/A
2011/06/21 SUPPL 31 Approval REMS N/A
2011/04/22 SUPPL 28 Approval Labeling UNKNOWN
2011/04/22 SUPPL 25 Approval Labeling UNKNOWN
2010/12/01 SUPPL 29 Approval Labeling 901 REQUIRED
2010/12/01 SUPPL 27 Approval Labeling UNKNOWN
2010/01/27 SUPPL 23 Approval Labeling UNKNOWN
2009/08/31 SUPPL 22 Approval Labeling 901 REQUIRED
2009/03/19 SUPPL 12 Approval Efficacy PRIORITY
2008/08/14 SUPPL 20 Approval Labeling STANDARD
2008/03/21 SUPPL 17 Approval Labeling STANDARD
2008/03/18 SUPPL 16 Approval Labeling STANDARD
2007/08/02 SUPPL 14 Approval Labeling STANDARD
2007/08/02 SUPPL 13 Approval Labeling STANDARD
2007/04/09 SUPPL 10 Approval Efficacy UNKNOWN
2007/04/09 SUPPL 8 Approval Labeling STANDARD
2006/11/29 SUPPL 9 Approval Labeling STANDARD
2006/09/20 SUPPL 11 Approval Labeling STANDARD
2006/07/03 SUPPL 7 Approval Labeling STANDARD
2006/07/03 SUPPL 6 Approval Labeling PRIORITY
2006/07/03 SUPPL 3 Approval Labeling PRIORITY
2005/02/18 SUPPL 5 Approval Labeling STANDARD
2003/12/24 ORIG 1 Approval Type 4 - New Combination PRIORITY
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 5229382 2011/04/23 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-962 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5229382 2011/04/23 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
5945416 2017/03/24 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-962 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5229382 2011/04/23 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
5945416 2017/03/24 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-962 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5229382 2011/04/23 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
5945416 2017/03/24 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-962 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5229382 2011/04/23 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5229382*PED 2011/10/23 PDF格式**本条是由Drugfuture回溯的历史信息**
5945416 2017/03/24 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6960577 2017/11/01 U-962 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 NC 2006/12/24**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/06/24**本条是由Drugfuture回溯的历史信息**
002 NC 2006/12/24**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/06/24**本条是由Drugfuture回溯的历史信息**
003 NC 2006/12/24**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/06/24**本条是由Drugfuture回溯的历史信息**
004 NC 2006/12/24**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/06/24**本条是由Drugfuture回溯的历史信息**
005 NC 2006/12/24**本条是由Drugfuture回溯的历史信息**
NPP 2016/07/26**本条是由Drugfuture回溯的历史信息**
PED 2007/06/24**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG BASE;EQ 3MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021520 001 NDA SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 3MG BASE Prescription Yes No AB 2007/04/09 LILLY
077742 001 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 3MG BASE Prescription No No AB 2012/11/02 PAR PHARM
078901 005 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 3MG BASE Prescription No No AB 2012/11/16 SANDOZ
202074 001 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 3MG BASE Prescription No No AB 2013/03/25 TEVA PHARMS
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG BASE;EQ 6MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021520 002 NDA SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE Prescription Yes No AB 2003/12/24 LILLY
077528 001 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE Prescription No No AB 2012/06/19 TEVA PHARMS
077742 002 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE Prescription No No AB 2012/11/02 PAR PHARM
078901 001 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE Prescription No No AB 2012/11/16 SANDOZ
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG BASE;EQ 6MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021520 003 NDA SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE Prescription Yes Yes AB 2003/12/24 LILLY
077528 003 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE Prescription No No AB 2012/06/19 TEVA PHARMS
077742 004 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE Prescription No No AB 2012/11/02 PAR PHARM
078901 002 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE Prescription No No AB 2012/11/16 SANDOZ
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG BASE;EQ 12MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021520 004 NDA SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE Prescription Yes No AB 2003/12/24 LILLY
077528 002 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE Prescription No No AB 2012/06/19 TEVA PHARMS
077742 003 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE Prescription No No AB 2012/11/02 PAR PHARM
078901 003 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE Prescription No No AB 2012/11/16 SANDOZ
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG BASE;EQ 12MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021520 005 NDA SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE Prescription Yes No AB 2003/12/24 LILLY
077528 004 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE Prescription No No AB 2012/06/19 TEVA PHARMS
077742 005 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE Prescription No No AB 2012/11/02 PAR PHARM
078901 004 ANDA OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE Prescription No No AB 2012/11/16 SANDOZ
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