药品注册申请号：078327
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 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE No No AB 2009/08/10 2009/08/10 Prescription
002 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE No No AB 2009/08/10 Prescription
003 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE No No AB 2009/08/10 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
2022/06/22 SUPPL-17（补充） Approval Manufacturing (CMC) UNKNOWN
2022/06/17 SUPPL-16（补充） Approval Labeling STANDARD
2019/05/17 SUPPL-11（补充） Approval Labeling STANDARD
2015/08/13 SUPPL-6（补充） Approval Labeling STANDARD
2015/08/13 SUPPL-3（补充） Approval Labeling STANDARD
2011/05/12 SUPPL-1（补充） Approval Labeling
2009/08/10 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:SUMATRIPTAN SUCCINATE 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
020132 002 NDA IMITREX SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription Yes No AB 1995/06/01 GLAXOSMITHKLINE
076554 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Discontinued No No AB 2009/08/10 SUN PHARM INDS LTD
076847 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/08/10 DR REDDYS LABS INC
076933 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/08/10 WATSON LABS
077744 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/08/10 MYLAN
078284 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/08/10 ORBION PHARMS
078295 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/08/10 SUN PHARM INDS
078327 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/08/10 AUROBINDO PHARMA
200263 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/06/19 COREPHARMA
活性成分:SUMATRIPTAN SUCCINATE 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
020132 003 NDA IMITREX SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription Yes No AB 1995/06/01 GLAXOSMITHKLINE
076554 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Discontinued No No AB 2009/08/10 SUN PHARM INDS LTD
076847 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/08/10 DR REDDYS LABS INC
076933 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/08/10 WATSON LABS
077744 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/08/10 MYLAN
078284 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/08/10 ORBION PHARMS
078295 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/08/10 SUN PHARM INDS
078327 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/08/10 AUROBINDO PHARMA
200263 002 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/06/19 COREPHARMA
活性成分:SUMATRIPTAN SUCCINATE 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
020132 001 NDA IMITREX SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription Yes Yes AB 1995/06/01 GLAXOSMITHKLINE
076572 001 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Discontinued No No AB 2009/02/09 SUN PHARM INDS LTD
076847 003 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/08/10 DR REDDYS LABS INC
076933 003 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/08/10 WATSON LABS
077744 003 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/08/10 MYLAN
078284 003 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/08/10 ORBION PHARMS
078295 003 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/08/10 SUN PHARM INDS
078327 003 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/08/10 AUROBINDO PHARMA
200263 003 ANDA SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/06/19 COREPHARMA
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
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