药品注册申请号：022115
申请类型：NDA (新药申请)
申请人：GLAXOSMITHKLINE LLC
申请人全名：GLAXOSMITHKLINE LLC
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 LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Yes No AB 2009/05/29 2009/05/29 Prescription
002 LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Yes Yes AB 2009/05/29 Prescription
003 LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Yes No AB 2009/05/29 Prescription
004 LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Yes Yes AB 2009/05/29 Prescription
005 LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Yes No AB 2010/04/14 Prescription
006 LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Yes No AB 2011/06/21 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
2009/05/29 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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
2025/10/10 SUPPL-34（补充） Approval Labeling-Package Insert STANDARD
2025/10/10 SUPPL-33（补充） Approval Labeling-Package Insert STANDARD
2025/04/25 SUPPL-32（补充） Approval Labeling-Package Insert STANDARD
2025/04/25 SUPPL-31（补充） Approval Labeling-Package Insert STANDARD
2021/03/31 SUPPL-29（补充） Approval Labeling-Package Insert STANDARD
2020/10/09 SUPPL-24（补充） Approval Labeling-Package Insert STANDARD
2020/08/31 SUPPL-27（补充） Approval Labeling-Package Insert STANDARD
2019/09/25 SUPPL-26（补充） Approval Labeling-Package Insert STANDARD
2019/08/14 SUPPL-25（补充） Approval Labeling-Package Insert STANDARD
2018/07/23 SUPPL-22（补充） Approval Labeling-Package Insert STANDARD
2018/06/27 SUPPL-23（补充） Approval Labeling-Package Insert STANDARD
2015/03/24 SUPPL-18（补充） Approval Labeling-Medication Guide STANDARD
2015/03/24 SUPPL-11（补充） Approval Labeling-Package Insert STANDARD
2014/12/30 SUPPL-14（补充） Approval Labeling UNKNOWN
2014/12/30 SUPPL-4（补充） Approval Labeling-Patient Package Insert UNKNOWN
2014/06/10 SUPPL-19（补充） Approval Labeling-Medication Guide STANDARD
2013/12/20 SUPPL-3（补充） Approval Labeling-Package Insert UNKNOWN
2012/08/01 SUPPL-17（补充） Approval Labeling-Medication Guide UNKNOWN
2011/11/29 SUPPL-16（补充） Approval Labeling-Medication Guide UNKNOWN
2011/08/04 SUPPL-13（补充） Approval Labeling UNKNOWN
2011/06/21 SUPPL-15（补充） Approval REMS-Modified N/A
2011/04/25 SUPPL-6（补充） Approval REMS-Modified,Efficacy-New Patient Population STANDARD
2010/10/24 SUPPL-10（补充） Approval Labeling-Medication Guide UNKNOWN
2010/10/24 SUPPL-9（补充） Approval REMS-Proposal N/A
2010/04/14 SUPPL-5（补充） Approval REMS-Proposal,REMS-Assessment N/A
2010/04/14 SUPPL-1（补充） Approval Manufacturing (CMC) 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
001 8637512 2029/01/07 Y 2014/02/12 PDF格式
002 8637512 2029/01/07 Y 2014/02/12 PDF格式
003 8637512 2029/01/07 Y 2014/02/12 PDF格式
004 8637512 2029/01/07 Y 2014/02/12 PDF格式
005 8637512 2029/01/07 Y 2014/02/12 PDF格式
006 8637512 2029/01/07 Y 2014/02/12 PDF格式
001 9144547 2023/09/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 9144547 2023/09/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 9144547 2023/09/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
004 9144547 2023/09/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
005 9144547 2023/09/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
006 9144547 2023/09/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 I-644 2014/04/25**本条是由Drugfuture回溯的历史信息**
002 I-644 2014/04/25**本条是由Drugfuture回溯的历史信息**
003 I-644 2014/04/25**本条是由Drugfuture回溯的历史信息**
004 I-644 2014/04/25**本条是由Drugfuture回溯的历史信息**
005 I-644 2014/04/25**本条是由Drugfuture回溯的历史信息**
006 I-644 2014/04/25**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:LAMOTRIGINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:25MG; 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
022115 001 NDA LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription Yes No AB 2009/05/29 GLAXOSMITHKLINE LLC
201374 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2012/12/26 PH HEALTH
202498 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2013/01/04 SCIEGEN PHARMS INC
201791 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2013/01/18 PH HEALTH
202383 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2013/06/19 DR REDDYS LABS LTD
200672 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2013/10/17 ACTAVIS ELIZABETH
203370 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2013/12/23 TORRENT
207497 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2018/11/30 AMNEAL PHARMS
207763 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2020/04/01 ZYDUS PHARMS
213949 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2021/12/08 YILING
>>>活性成分:LAMOTRIGINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:50MG; 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
022115 002 NDA LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription Yes Yes AB 2009/05/29 GLAXOSMITHKLINE LLC
201374 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2012/12/26 PH HEALTH
202498 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2013/01/04 SCIEGEN PHARMS INC
201791 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2013/01/18 PH HEALTH
202383 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2013/06/19 DR REDDYS LABS LTD
200672 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2013/10/17 ACTAVIS ELIZABETH
203370 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2013/12/23 TORRENT
207497 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2018/11/30 AMNEAL PHARMS
207763 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2020/04/01 ZYDUS PHARMS
213949 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 50MG Prescription No No AB 2021/12/08 YILING
>>>活性成分:LAMOTRIGINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:100MG; 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
022115 003 NDA LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription Yes No AB 2009/05/29 GLAXOSMITHKLINE LLC
201374 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2012/12/26 PH HEALTH
202498 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2013/01/04 SCIEGEN PHARMS INC
201791 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2013/01/18 PH HEALTH
202887 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2013/06/17 RUBICON RESEARCH
202383 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2013/06/19 DR REDDYS LABS LTD
200672 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2013/10/17 ACTAVIS ELIZABETH
203370 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2013/12/23 TORRENT
207497 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2018/11/30 AMNEAL PHARMS
207763 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2020/04/01 ZYDUS PHARMS
213949 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2021/12/08 YILING
>>>活性成分:LAMOTRIGINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:200MG; 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
022115 004 NDA LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription Yes Yes AB 2009/05/29 GLAXOSMITHKLINE LLC
201374 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2012/12/26 PH HEALTH
202498 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2013/01/04 SCIEGEN PHARMS INC
201791 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2013/01/18 PH HEALTH
202887 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2013/06/17 RUBICON RESEARCH
202383 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2013/06/19 DR REDDYS LABS LTD
200672 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2013/10/17 ACTAVIS ELIZABETH
203370 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB 2013/12/23 TORRENT
207497 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2018/11/30 AMNEAL PHARMS
207763 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2020/04/01 ZYDUS PHARMS
213949 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2021/12/08 YILING
211821 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2024/10/01 ALEMBIC
>>>活性成分:LAMOTRIGINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:300MG; 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
022115 005 NDA LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription Yes No AB 2010/04/14 GLAXOSMITHKLINE LLC
201374 006 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2012/12/26 PH HEALTH
202498 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2013/01/04 SCIEGEN PHARMS INC
201791 006 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2013/01/18 PH HEALTH
202383 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2013/06/19 DR REDDYS LABS LTD
200672 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2013/10/17 ACTAVIS ELIZABETH
207497 006 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2018/11/30 AMNEAL PHARMS
207763 006 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2020/04/01 ZYDUS PHARMS
213949 006 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2021/12/08 YILING
211821 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2024/10/01 ALEMBIC
>>>活性成分:LAMOTRIGINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:250MG; 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
022115 006 NDA LAMICTAL XR LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription Yes No AB 2011/06/21 GLAXOSMITHKLINE LLC
201374 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2012/12/26 PH HEALTH
201791 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2013/01/18 PH HEALTH
200672 006 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2013/11/13 ACTAVIS ELIZABETH
202383 006 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2018/09/06 DR REDDYS LABS LTD
207497 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2018/11/30 AMNEAL PHARMS
207763 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2020/04/01 ZYDUS PHARMS
213949 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2021/12/08 YILING
211821 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, EXTENDED RELEASE;ORAL 250MG Prescription No No AB 2024/10/01 ALEMBIC
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