药品注册申请号：021411
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 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 2002/11/26 2002/11/26 Discontinued
002 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2002/11/26 Discontinued
003 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2002/11/26 Discontinued
004 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2002/11/26 Discontinued
005 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2002/11/26 Discontinued
006 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2002/11/26 Discontinued
007 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2005/02/14 Discontinued
008 STRATTERA ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2005/02/14 Discontinued
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
2002/11/26 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity 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
2022/01/06 SUPPL-50（补充） Approval Labeling-Package Insert 901 REQUIRED
2020/02/25 SUPPL-49（补充） Approval Labeling-Package Insert STANDARD
2017/05/19 SUPPL-48（补充） Approval Labeling-Package Insert 901 REQUIRED
2015/05/26 SUPPL-46（补充） Approval Labeling-Package Insert STANDARD
2015/04/17 SUPPL-47（补充） Approval Labeling-Package Insert STANDARD
2014/02/21 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
2014/02/20 SUPPL-44（补充） Approval Labeling-Package Insert STANDARD
2013/12/04 SUPPL-45（补充） Approval Labeling-Package Insert STANDARD
2013/08/05 SUPPL-42（补充） Approval Labeling-Package Insert STANDARD
2013/08/05 SUPPL-40（补充） Approval Labeling-Package Insert STANDARD
2013/05/20 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
2012/08/16 SUPPL-36（补充） Approval Labeling STANDARD
2012/07/05 SUPPL-34（补充） Approval Labeling-Package Insert STANDARD
2012/06/14 SUPPL-39（补充） Approval Labeling-Package Insert STANDARD
2011/03/07 SUPPL-35（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2010/07/29 SUPPL-32（补充） Approval Labeling-Package Insert UNKNOWN
2009/06/03 SUPPL-30（补充） Approval Labeling STANDARD
2009/06/03 SUPPL-29（补充） Approval Labeling STANDARD
2008/07/23 SUPPL-26（补充） Approval Labeling STANDARD
2008/07/23 SUPPL-25（补充） Approval Labeling STANDARD
2008/07/23 SUPPL-24（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2008/05/07 SUPPL-5（补充） Approval Efficacy-New Indication STANDARD
2007/09/28 SUPPL-19（补充） Approval Efficacy-Labeling Change With Clinical Data UNKNOWN
2007/04/25 SUPPL-21（补充） Approval Labeling STANDARD
2007/04/25 SUPPL-15（补充） Approval Labeling STANDARD
2007/04/25 SUPPL-13（补充） Approval Labeling STANDARD
2007/04/25 SUPPL-12（补充） Approval Labeling STANDARD
2007/04/25 SUPPL-4（补充） Approval Labeling STANDARD
2006/10/19 SUPPL-18（补充） Approval Labeling STANDARD
2005/11/08 SUPPL-14（补充） Approval Labeling STANDARD
2005/05/26 SUPPL-8（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2005/02/14 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
2005/02/01 SUPPL-11（补充） Approval Labeling STANDARD
2005/02/01 SUPPL-2（补充） Approval Labeling STANDARD
2003/01/17 SUPPL-1（补充） Approval Labeling 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
001 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
006 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
007 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
008 5658590 2016/11/26 U-494 PDF格式**本条是由Drugfuture回溯的历史信息**
5658590*PED 2017/05/26 U-494 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 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**本条是由Drugfuture回溯的历史信息**
002 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**本条是由Drugfuture回溯的历史信息**
003 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**本条是由Drugfuture回溯的历史信息**
004 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**本条是由Drugfuture回溯的历史信息**
005 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**本条是由Drugfuture回溯的历史信息**
006 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**本条是由Drugfuture回溯的历史信息**
007 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**本条是由Drugfuture回溯的历史信息**
008 I-562 2011/05/07**本条是由Drugfuture回溯的历史信息**
M-66 2010/09/28**本条是由Drugfuture回溯的历史信息**
M-78 2011/07/23**本条是由Drugfuture回溯的历史信息**
NCE 2007/11/26**本条是由Drugfuture回溯的历史信息**
PED 2008/05/26**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:ATOMOXETINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2002/11/26 LILLY
>>>活性成分:ATOMOXETINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2002/11/26 LILLY
>>>活性成分:ATOMOXETINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2002/11/26 LILLY
>>>活性成分:ATOMOXETINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2002/11/26 LILLY
>>>活性成分:ATOMOXETINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2002/11/26 LILLY
>>>活性成分:ATOMOXETINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2005/02/14 LILLY
>>>活性成分:ATOMOXETINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2005/02/14 LILLY
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
©2006-2026 DrugFuture->U.S. FDA Drugs Database