药品注册申请号:077129
申请类型:ANDA (仿制药申请)
申请人:WATSON LABS
申请人全名:WATSON LABORATORIES INC
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 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE No No AB 2008/01/08 2008/01/08 Prescription
002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE No No AB 2008/01/08 Prescription
003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE No No AB 2008/01/08 Prescription
004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE No No AB 2008/01/08 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2015/11/20 SUPPL 3 Approval Labeling STANDARD
2015/11/20 SUPPL 2 Approval Labeling STANDARD
2008/01/08 ORIG 1 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
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
与本品治疗等效的药品
活性成分:RIVASTIGMINE TARTRATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 1.5MG 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
077131 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2007/10/22 SUN PHARM
077130 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No Yes AB 2007/10/31 DR REDDYS LABS INC
077129 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2008/01/08 WATSON LABS
091689 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2012/06/12 ALEMBIC PHARMS LTD
203148 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2014/08/22 MACLEODS PHARMS LTD
090879 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2015/06/10 ORCHID HLTHCARE
204572 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA LTD
203844 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2017/02/13 CADILA PHARMS LTD
207797 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2017/09/28 CHARTWELL RX
活性成分:RIVASTIGMINE TARTRATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 3MG 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
077131 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2007/10/22 SUN PHARM
077130 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2007/10/31 DR REDDYS LABS INC
077129 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2008/01/08 WATSON LABS
091689 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2012/06/12 ALEMBIC PHARMS LTD
203148 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2014/08/22 MACLEODS PHARMS LTD
090879 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2015/06/10 ORCHID HLTHCARE
204572 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA LTD
203844 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2017/02/13 CADILA PHARMS LTD
207797 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2017/09/28 CHARTWELL RX
活性成分:RIVASTIGMINE TARTRATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 4.5MG 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
077131 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2007/10/22 SUN PHARM
077130 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2007/10/31 DR REDDYS LABS INC
077129 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2008/01/08 WATSON LABS
091689 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2012/06/12 ALEMBIC PHARMS LTD
203148 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2014/08/22 MACLEODS PHARMS LTD
090879 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2015/06/10 ORCHID HLTHCARE
204572 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA LTD
203844 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2017/02/13 CADILA PHARMS LTD
207797 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2017/09/28 CHARTWELL RX
活性成分:RIVASTIGMINE TARTRATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 6MG 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
077131 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2007/10/22 SUN PHARM
077130 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No Yes AB 2007/10/31 DR REDDYS LABS INC
077129 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2008/01/08 WATSON LABS
091689 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2012/06/12 ALEMBIC PHARMS LTD
203148 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2014/08/22 MACLEODS PHARMS LTD
090879 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2015/06/10 ORCHID HLTHCARE
204572 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA LTD
203844 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2017/02/13 CADILA PHARMS LTD
207797 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2017/09/28 CHARTWELL RX
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