药品注册申请号：203148
申请类型：ANDA (仿制药申请)
申请人：MACLEODS PHARMS LTD
申请人全名：MACLEODS PHARMACEUTICALS 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 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE No No AB 2014/08/22 2014/08/22 Prescription
002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE No No AB 2014/08/22 Prescription
003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE No No AB 2014/08/22 Prescription
004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE No No AB 2014/08/22 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2014/08/22 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2019/07/23 SUPPL-11（补充） Approval Labeling-Package Insert STANDARD
2019/07/23 SUPPL-4（补充） Approval Labeling-Package Insert STANDARD
2015/11/17 SUPPL-1（补充） Approval Labeling-Package Insert STANDARD
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: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 Discontinued 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 ORBION PHARMS
204572 001 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA
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 Discontinued 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 ORBION PHARMS
204572 002 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA
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 Discontinued 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 ORBION PHARMS
204572 003 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA
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 Discontinued 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 ORBION PHARMS
204572 004 ANDA RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2016/03/25 AUROBINDO PHARMA
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
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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