药品注册申请号：077206
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA
申请人全名：AUROBINDO PHARMA 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 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No AB 2007/02/06 2007/02/06 Prescription
002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No AB 2007/02/06 Prescription
003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No AB 2007/02/06 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
2024/02/01 SUPPL-41（补充） Approval Labeling STANDARD
2023/07/26 SUPPL-39（补充） Approval Labeling STANDARD
2023/07/26 SUPPL-38（补充） Approval Labeling STANDARD
2020/02/21 SUPPL-31（补充） Approval Labeling STANDARD
2020/02/21 SUPPL-30（补充） Approval Labeling STANDARD
2020/02/21 SUPPL-29（补充） Approval Labeling STANDARD
2016/03/14 SUPPL-24（补充） Approval Labeling STANDARD
2016/03/14 SUPPL-20（补充） Approval Labeling STANDARD
2016/03/14 SUPPL-16（补充） Approval Manufacturing (CMC)
2016/03/14 SUPPL-1（补充） Approval Labeling
2012/05/21 SUPPL-19（补充） Approval Labeling
2011/09/29 SUPPL-17（补充） Approval Labeling
2011/03/14 SUPPL-14（补充） Approval Labeling
2009/02/25 SUPPL-13（补充） Approval Labeling
2008/09/15 SUPPL-9（补充） Approval Labeling
2008/06/25 SUPPL-4（补充） Approval Labeling
2007/12/26 SUPPL-6（补充） Approval Labeling
2007/02/06 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:SERTRALINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
019839 005 NDA ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription Yes No AB 1996/03/06 VIATRIS
076465 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2006/08/11 HERITAGE PHARMA AVET
076881 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2007/02/06 STRIDES PHARMA
076882 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2007/02/06 VIWIT PHARM
077206 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2007/02/06 AUROBINDO PHARMA
077397 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2007/02/06 INVAGEN PHARMS
077670 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2007/02/06 LUPIN
076442 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2007/04/30 SCIEGEN PHARMS INC
078403 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2008/01/08 GRANULES
078677 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/03/04 REYOUNG
078175 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2010/07/21 OXFORD PHARMS
202825 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2014/11/07 ACCORD HLTHCARE
214790 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2021/05/03 ASCENT PHARMS INC
活性成分:SERTRALINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 50MG 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
019839 001 NDA ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription Yes No AB 1991/12/30 VIATRIS
076465 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2006/08/11 HERITAGE PHARMA AVET
076881 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2007/02/06 STRIDES PHARMA
076882 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2007/02/06 VIWIT PHARM
077206 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2007/02/06 AUROBINDO PHARMA
077397 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2007/02/06 INVAGEN PHARMS
077670 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2007/02/06 LUPIN
076442 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2007/04/30 SCIEGEN PHARMS INC
078403 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2008/01/08 GRANULES
078677 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/03/04 REYOUNG
078175 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2010/07/21 OXFORD PHARMS
202825 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2014/11/07 ACCORD HLTHCARE
214790 002 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2021/05/03 ASCENT PHARMS INC
活性成分:SERTRALINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
019839 002 NDA ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription Yes Yes AB 1991/12/30 VIATRIS
076465 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2006/08/11 HERITAGE PHARMA AVET
076881 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2007/02/06 STRIDES PHARMA
076882 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2007/02/06 VIWIT PHARM
077206 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2007/02/06 AUROBINDO PHARMA
077397 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2007/02/06 INVAGEN PHARMS
077670 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2007/02/06 LUPIN
076442 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2007/04/30 SCIEGEN PHARMS INC
078403 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2008/01/08 GRANULES
078677 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/03/04 REYOUNG
078175 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2010/07/21 OXFORD PHARMS
202825 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2014/11/07 ACCORD HLTHCARE
214790 003 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2021/05/03 ASCENT PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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