药品注册申请号：079017
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS USA INC
申请人全名：ZYDUS PHARMACEUTICALS USA 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 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE No No AB 2010/09/16 2010/09/16 Prescription
002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE No No AB 2010/09/16 Prescription
003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE No No AB 2010/09/16 Prescription
004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE No No AB 2010/09/16 Prescription
005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE No No AB 2010/09/16 Prescription
006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE No No AB 2010/09/16 Prescription
007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE No No AB 2023/04/05 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
2015/08/25 SUPPL-6（补充） Approval Labeling STANDARD
2015/08/25 SUPPL-5（补充） Approval Labeling STANDARD
2013/08/07 SUPPL-2（补充） Approval Labeling
2010/09/16 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
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:ATOMOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 18MG 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
021411 003 NDA STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription Yes No AB 2002/11/26 LILLY
079017 001 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription No No AB 2010/09/16 ZYDUS PHARMS USA INC
079019 002 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription No No AB 2017/05/30 GLENMARK PHARMS LTD
079022 002 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription No No AB 2017/05/30 TEVA PHARMS USA
078983 002 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription No No AB 2017/05/30 APOTEX
079016 002 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription No No AB 2017/05/30 AUROBINDO PHARMA
090609 002 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription No No AB 2018/02/23 DR REDDYS
202682 002 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE Prescription No No AB 2021/03/11 HETERO LABS LTD V
活性成分:ATOMOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG 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
021411 004 NDA STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription Yes No AB 2002/11/26 LILLY
079017 002 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2010/09/16 ZYDUS PHARMS USA INC
079019 003 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2017/05/30 GLENMARK PHARMS LTD
079022 003 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2017/05/30 TEVA PHARMS USA
078983 003 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2017/05/30 APOTEX
079016 003 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2017/05/30 AUROBINDO PHARMA
090609 003 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2018/02/23 DR REDDYS
202682 003 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2021/03/11 HETERO LABS LTD V
活性成分:ATOMOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 40MG 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
021411 005 NDA STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription Yes No AB 2002/11/26 LILLY
079017 003 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2010/09/16 ZYDUS PHARMS USA INC
079019 004 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2017/05/30 GLENMARK PHARMS LTD
079022 004 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2017/05/30 TEVA PHARMS USA
078983 004 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2017/05/30 APOTEX
079016 004 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2017/05/30 AUROBINDO PHARMA
090609 004 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2018/02/23 DR REDDYS
202682 004 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2021/03/11 HETERO LABS LTD V
活性成分:ATOMOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 60MG 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
021411 006 NDA STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription Yes Yes AB 2002/11/26 LILLY
079017 004 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2010/09/16 ZYDUS PHARMS USA INC
079019 005 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2017/05/30 GLENMARK PHARMS LTD
079022 005 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2017/05/30 TEVA PHARMS USA
078983 005 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2017/05/30 APOTEX
079016 005 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2017/05/30 AUROBINDO PHARMA
090609 005 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2018/02/23 DR REDDYS
202682 005 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2021/03/11 HETERO LABS LTD V
活性成分:ATOMOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 80MG 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
021411 007 NDA STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription Yes No AB 2005/02/14 LILLY
079017 005 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2010/09/16 ZYDUS PHARMS USA INC
079019 006 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2017/05/30 GLENMARK PHARMS LTD
079022 006 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2017/05/30 TEVA PHARMS USA
078983 006 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2017/05/30 APOTEX
079016 006 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2017/05/30 AUROBINDO PHARMA
090609 006 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2018/02/23 DR REDDYS
202682 006 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2021/03/11 HETERO LABS LTD V
活性成分:ATOMOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 100MG 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
021411 008 NDA STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription Yes No AB 2005/02/14 LILLY
079017 006 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2010/09/16 ZYDUS PHARMS USA INC
079019 007 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/05/30 GLENMARK PHARMS LTD
079022 007 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/05/30 TEVA PHARMS USA
078983 007 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/05/30 APOTEX
079016 007 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/05/30 AUROBINDO PHARMA
090609 007 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2018/02/23 DR REDDYS
202682 007 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2021/03/11 HETERO LABS LTD V
活性成分:ATOMOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;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
021411 002 NDA STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription Yes No AB 2002/11/26 LILLY
078983 001 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2017/05/30 APOTEX
079016 001 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2017/05/30 AUROBINDO PHARMA
079019 001 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2017/05/30 GLENMARK PHARMS LTD
079022 001 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2017/05/30 TEVA PHARMS USA
090609 001 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2018/02/23 DR REDDYS
202682 001 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2021/03/11 HETERO LABS LTD V
079017 007 ANDA ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2023/04/05 ZYDUS PHARMS USA INC
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