药品注册申请号:077528
申请类型:ANDA (仿制药申请)
申请人:TEVA PHARMS
申请人全名:TEVA PHARMACEUTICALS USA
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 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE No No AB 2012/06/19 2012/06/19 Prescription
002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE No No AB 2012/06/19 Prescription
003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE No No AB 2012/06/19 Prescription
004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE No No AB 2012/06/19 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
2014/12/19 SUPPL 5 Approval Labeling STANDARD
2014/12/19 SUPPL 4 Approval Labeling STANDARD
2014/12/19 SUPPL 3 Approval Labeling STANDARD
2013/04/22 SUPPL 2 Approval Labeling STANDARD
2012/12/31 SUPPL 1 Approval Labeling STANDARD
2012/06/19 ORIG 1 Approval
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
与本品相关的市场独占权保护信息
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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 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 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 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 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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