药品注册申请号：206210
申请类型：ANDA (仿制药申请)
申请人：ACTAVIS LABS FL
申请人全名：ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA 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 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG No No AB1;AB1 2023/03/10 2023/03/10 Prescription
002 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG No No AB1;AB1 2023/03/10 Prescription
003 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG No No AB1;AB1 2023/03/10 Prescription
004 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG No No AB1;AB1 2023/03/10 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
>>>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
2023/03/10 ORIG-2（原始申请） Approval STANDARD
2023/03/10 ORIG-1（原始申请） Approval STANDARD
>>>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
2025/10/23 SUPPL-5（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2025/10/23 SUPPL-2（补充） Approval Labeling-Medication Guide,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:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:25MG; 治疗等效代码:AB1<<<
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
201635 001 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription Yes No AB1 2013/08/16 SUPERNUS PHARMS
207382 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2017/11/24 ZYDUS
206210 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
205976 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/05/04 PH HEALTH
217248 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
217231 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2024/07/11 LUPIN LTD
>>>活性成分:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:25MG; 治疗等效代码:AB1<<<
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
201635 001 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription Yes No AB1 2013/08/16 SUPERNUS PHARMS
207382 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2017/11/24 ZYDUS
206210 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
205976 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/05/04 PH HEALTH
217248 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
217231 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB1 2024/07/11 LUPIN LTD
>>>活性成分:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:50MG; 治疗等效代码:AB1<<<
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
201635 002 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription Yes No AB1 2013/08/16 SUPERNUS PHARMS
207382 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2017/11/24 ZYDUS
206210 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
205976 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/05/04 PH HEALTH
217248 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
217231 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2024/07/11 LUPIN LTD
>>>活性成分:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:50MG; 治疗等效代码:AB1<<<
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
201635 002 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription Yes No AB1 2013/08/16 SUPERNUS PHARMS
207382 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2017/11/24 ZYDUS
206210 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
205976 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/05/04 PH HEALTH
217248 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
217231 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 002 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB1 2024/07/11 LUPIN LTD
>>>活性成分:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:100MG; 治疗等效代码:AB1<<<
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
201635 003 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription Yes No AB1 2013/08/16 SUPERNUS PHARMS
207382 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2017/11/24 ZYDUS
206210 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
205976 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/05/04 PH HEALTH
217248 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
217231 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2024/07/11 LUPIN LTD
>>>活性成分:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:100MG; 治疗等效代码:AB1<<<
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
201635 003 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription Yes No AB1 2013/08/16 SUPERNUS PHARMS
207382 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2017/11/24 ZYDUS
206210 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
205976 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/05/04 PH HEALTH
217248 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
217231 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 003 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2024/07/11 LUPIN LTD
>>>活性成分:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:200MG; 治疗等效代码:AB1<<<
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
201635 004 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription Yes Yes AB1 2013/08/16 SUPERNUS PHARMS
216167 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB1 2023/02/09 ZYDUS PHARMS
205976 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/03/01 PH HEALTH
206210 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
217248 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
207382 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/10/30 ZYDUS
217231 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2024/07/11 LUPIN LTD
>>>活性成分:TOPIRAMATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:200MG; 治疗等效代码:AB1<<<
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
201635 004 NDA TROKENDI XR TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription Yes Yes AB1 2013/08/16 SUPERNUS PHARMS
216167 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB1 2023/02/09 ZYDUS PHARMS
205976 001 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/03/01 PH HEALTH
206210 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/03/10 ACTAVIS LABS FL
217248 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/06/20 ALKEM LABS LTD
215663 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB1 2023/08/15 AJANTA PHARMA LTD
207382 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/10/30 ZYDUS
217231 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/11/17 DR REDDYS
215561 004 ANDA TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2024/07/11 LUPIN LTD
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