药品注册申请号：090432
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA LTD
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 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE No No AB 2012/09/11 2012/09/11 Prescription
002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE No No AB 2012/09/11 Prescription
003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE No No AB 2012/09/11 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
2024/10/07 SUPPL-27（补充） Approval Labeling STANDARD
2024/10/07 SUPPL-24（补充） Approval Labeling STANDARD
2024/10/07 SUPPL-21（补充） Approval Labeling STANDARD
2024/10/07 SUPPL-18（补充） Approval Labeling STANDARD
2024/10/07 SUPPL-15（补充） Approval Labeling STANDARD
2024/10/07 SUPPL-12（补充） Approval Labeling STANDARD
2015/11/12 SUPPL-9（补充） Approval Labeling STANDARD
2014/09/15 SUPPL-8（补充） Approval Labeling STANDARD
2014/05/20 SUPPL-6（补充） Approval Manufacturing (CMC) UNKNOWN
2013/05/31 SUPPL-2（补充） Approval Labeling STANDARD
2012/09/11 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:ESCITALOPRAM OXALATE 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG 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
021323 001 NDA LEXAPRO ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription Yes No AB 2002/08/14 ABBVIE
076765 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2012/03/14 TEVA PHARMS USA
077734 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 ZYDUS LIFESCIENCES
078169 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 CHARTWELL RX
078604 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 INVAGEN PHARMS
078777 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 GRAVITI PHARMS
090432 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 AUROBINDO PHARMA LTD
090939 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 TORRENT PHARMS LTD
202210 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 MACLEODS PHARMS LTD
202389 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/11 ACCORD HLTHCARE
202280 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/09/12 JUBILANT CADISTA
077512 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2012/09/12 ANIMA
078032 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2015/08/28 PRINSTON INC
205619 001 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/05/17 AMNEAL PHARMS
活性成分:ESCITALOPRAM OXALATE 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
021323 002 NDA LEXAPRO ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription Yes No AB 2002/08/14 ABBVIE
076765 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2012/03/14 TEVA PHARMS USA
077734 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 ZYDUS LIFESCIENCES
078169 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 CHARTWELL RX
078604 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 INVAGEN PHARMS
078777 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 GRAVITI PHARMS
090432 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 AUROBINDO PHARMA LTD
090939 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 TORRENT PHARMS LTD
202210 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 MACLEODS PHARMS LTD
202389 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/11 ACCORD HLTHCARE
202280 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/12 JUBILANT CADISTA
077512 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2012/09/12 ANIMA
078032 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2015/08/28 PRINSTON INC
205619 002 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/05/17 AMNEAL PHARMS
活性成分:ESCITALOPRAM OXALATE 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
021323 003 NDA LEXAPRO ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription Yes Yes AB 2002/08/14 ABBVIE
076765 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2012/03/14 TEVA PHARMS USA
077734 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 ZYDUS LIFESCIENCES
078169 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 CHARTWELL RX
078604 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 INVAGEN PHARMS
078777 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 GRAVITI PHARMS
090432 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 AUROBINDO PHARMA LTD
090939 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 TORRENT PHARMS LTD
202210 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 MACLEODS PHARMS LTD
202389 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/11 ACCORD HLTHCARE
202280 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/09/12 JUBILANT CADISTA
077512 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2012/09/12 ANIMA
078032 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2015/08/28 PRINSTON INC
205619 003 ANDA ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2017/05/17 AMNEAL PHARMS
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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