药品注册申请号：202490
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 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE No No AB 2012/12/31 2012/12/31 Prescription
002 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE No No AB 2012/12/31 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
2020/10/06 SUPPL-8（补充） Approval Labeling STANDARD
2015/11/09 SUPPL-4（补充） Approval Labeling STANDARD
2012/12/31 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:RIZATRIPTAN BENZOATE 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
079230 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2012/12/31 SANDOZ
200482 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2012/12/31 NATCO PHARMA LTD
201967 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2012/12/31 GLENMARK PHARMS LTD
201993 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/12/31 MYLAN PHARMS INC
202047 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/12/31 CREEKWOOD PHARMS
202490 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/12/31 AUROBINDO PHARMA LTD
077263 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/12/31 TEVA PHARMS
077526 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2013/03/26 CHARTWELL RX
204339 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2013/07/01 INVAGEN PHARMS
203147 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2014/02/11 MACLEODS PHARMS LTD
203269 001 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/02/18 ALKEM LABS LTD
活性成分:RIZATRIPTAN BENZOATE 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
020864 002 NDA MAXALT RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription Yes Yes AB 1998/06/29 ORGANON LLC
077263 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/12/31 TEVA PHARMS
079230 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2012/12/31 SANDOZ
200482 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2012/12/31 NATCO PHARMA LTD
201967 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2012/12/31 GLENMARK PHARMS LTD
201993 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/12/31 MYLAN PHARMS INC
202047 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/12/31 CREEKWOOD PHARMS
202490 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/12/31 AUROBINDO PHARMA LTD
077526 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2013/03/26 CHARTWELL RX
204339 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2013/07/01 INVAGEN PHARMS
203147 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2014/02/11 MACLEODS PHARMS LTD
203269 002 ANDA RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/02/18 ALKEM LABS LTD
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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