药品注册申请号：211653
申请类型：ANDA (仿制药申请)
申请人：LUPIN LTD
申请人全名：LUPIN LTD
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 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No AB 2019/04/15 2019/04/15 Prescription
002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE No No AB 2019/04/15 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2019/04/15 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/08/18 SUPPL-5（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2021/09/20 SUPPL-2（补充） Approval Labeling-Package Insert STANDARD
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
无
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
无
与本品治疗等效的药品
>>>活性成分:FLUOXETINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 10MG 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
075872 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2002/01/29 TEVA
076006 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2002/01/30 DR REDDYS
203836 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/08/19 PH HEALTH
208698 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/04/05 ALEMBIC
211696 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2019/01/30 APPCO
210935 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/03/20 SCIEGEN PHARMS INC
211653 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/04/15 LUPIN LTD
213286 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2020/04/08 AUROBINDO PHARMA LTD
211444 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2022/09/13 CHARTWELL RX
212684 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/04/05 STRIDES PHARMA
>>>活性成分:FLUOXETINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 20MG 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
203836 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/08/19 PH HEALTH
208698 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2017/04/05 ALEMBIC
076006 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/04/23 DR REDDYS
075872 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2019/01/04 TEVA
211696 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2019/01/30 APPCO
210935 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/03/20 SCIEGEN PHARMS INC
211653 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/04/15 LUPIN LTD
213286 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No Yes AB 2020/04/08 AUROBINDO PHARMA LTD
211444 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2022/09/13 CHARTWELL RX
212684 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2024/04/05 STRIDES PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database