药品注册申请号:077742
申请类型:ANDA (仿制药申请)
申请人:PAR PHARM
申请人全名:PAR PHARMACEUTICAL INC
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 3MG BASE No No AB 2012/11/02 2012/11/02 Prescription
002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE No No AB 2012/11/02 Prescription
003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE No No AB 2012/11/02 Prescription
004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE No No AB 2012/11/02 Prescription
005 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE No No AB 2012/11/02 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2024/01/16 SUPPL-21(补充) Approval Labeling STANDARD
2023/05/01 SUPPL-19(补充) Approval Labeling STANDARD
2021/02/04 SUPPL-18(补充) Approval Labeling STANDARD
2021/02/04 SUPPL-12(补充) Approval Labeling STANDARD
2021/02/04 SUPPL-11(补充) Approval Labeling STANDARD
2015/10/05 SUPPL-9(补充) Approval Labeling STANDARD
2013/03/14 SUPPL-2(补充) Approval Labeling STANDARD
2012/11/02 ORIG-1(原始申请) 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
关联产品号独占权代码失效日期备注
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 EPIC PHARMA LLC
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 EPIC PHARMA LLC
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 EPIC PHARMA LLC
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 EPIC PHARMA LLC
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 EPIC PHARMA LLC
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