药品注册申请号：090170
申请类型：ANDA (仿制药申请)
申请人：UNICHEM LABS LTD
申请人全名：UNICHEM LABORATORIES 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 LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG No No AB 2011/10/06 2011/10/06 Prescription
002 LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG No No AB 2011/10/06 Prescription
003 LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG No No AB 2011/10/06 Prescription
004 LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG No No AB 2011/10/06 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
2023/06/08 SUPPL-34（补充） Approval Labeling STANDARD
2023/06/08 SUPPL-30（补充） Approval Labeling STANDARD
2023/06/08 SUPPL-29（补充） Approval Labeling STANDARD
2020/01/17 SUPPL-25（补充） Approval Labeling STANDARD
2020/01/17 SUPPL-23（补充） Approval Labeling STANDARD
2020/01/17 SUPPL-21（补充） Approval Labeling STANDARD
2020/01/17 SUPPL-15（补充） Approval Labeling STANDARD
2014/12/10 SUPPL-9（补充） Approval Labeling STANDARD
2014/12/10 SUPPL-6（补充） Approval Labeling STANDARD
2012/05/21 SUPPL-2（补充） Approval Labeling
2012/03/27 SUPPL-1（补充） Approval Labeling
2011/10/06 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:LAMOTRIGINE 剂型/给药途径:TABLET;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
020241 005 NDA LAMICTAL LAMOTRIGINE TABLET;ORAL 25MG Prescription Yes Yes AB 1994/12/27 GLAXOSMITHKLINE LLC
076708 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2009/01/27 DR REDDYS LABS LTD
077633 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2009/01/27 ZYDUS PHARMS USA
078525 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2009/01/27 TARO PHARM INDS
078625 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2009/01/27 RUBICON
078947 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2009/01/27 TORRENT PHARMS
078956 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2009/01/27 AUROBINDO PHARMA
079132 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2009/01/27 JUBILANT CADISTA
078691 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2010/06/01 LUPIN LTD
090607 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2011/01/13 ALEMBIC PHARMS LTD
090170 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2011/10/06 UNICHEM LABS LTD
090169 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2012/05/12 GLENMARK PHARMS LTD
200694 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 25MG Prescription No No AB 2013/06/14 ALKEM LABS LTD
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET;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
020241 001 NDA LAMICTAL LAMOTRIGINE TABLET;ORAL 100MG Prescription Yes No AB 1994/12/27 GLAXOSMITHKLINE LLC
076708 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2009/01/27 DR REDDYS LABS LTD
077633 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2009/01/27 ZYDUS PHARMS USA
078525 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2009/01/27 TARO PHARM INDS
078625 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2009/01/27 RUBICON
078947 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2009/01/27 TORRENT PHARMS
078956 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2009/01/27 AUROBINDO PHARMA
079132 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2009/01/27 JUBILANT CADISTA
078691 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2010/06/01 LUPIN LTD
090607 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2011/01/13 ALEMBIC PHARMS LTD
090170 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2011/10/06 UNICHEM LABS LTD
090169 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2012/05/12 GLENMARK PHARMS LTD
200694 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 100MG Prescription No No AB 2013/06/14 ALKEM LABS LTD
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET;ORAL 规格:150MG 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
020241 002 NDA LAMICTAL LAMOTRIGINE TABLET;ORAL 150MG Prescription Yes No AB 1994/12/27 GLAXOSMITHKLINE LLC
076708 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2009/01/27 DR REDDYS LABS LTD
077633 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2009/01/27 ZYDUS PHARMS USA
078525 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2009/01/27 TARO PHARM INDS
078625 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2009/01/27 RUBICON
078947 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2009/01/27 TORRENT PHARMS
078956 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2009/01/27 AUROBINDO PHARMA
079132 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2009/01/27 JUBILANT CADISTA
078691 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2010/06/01 LUPIN LTD
090607 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2011/01/13 ALEMBIC PHARMS LTD
090170 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2011/10/06 UNICHEM LABS LTD
090169 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2012/05/12 GLENMARK PHARMS LTD
200694 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 150MG Prescription No No AB 2013/06/14 ALKEM LABS LTD
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET;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
020241 003 NDA LAMICTAL LAMOTRIGINE TABLET;ORAL 200MG Prescription Yes No AB 1994/12/27 GLAXOSMITHKLINE LLC
076708 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2009/01/27 DR REDDYS LABS LTD
077633 005 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2009/01/27 ZYDUS PHARMS USA
078525 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2009/01/27 TARO PHARM INDS
078625 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2009/01/27 RUBICON
078947 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2009/01/27 TORRENT PHARMS
078956 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2009/01/27 AUROBINDO PHARMA
079132 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2009/01/27 JUBILANT CADISTA
078691 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2010/06/01 LUPIN LTD
090607 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2011/01/13 ALEMBIC PHARMS LTD
090170 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2011/10/06 UNICHEM LABS LTD
090169 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2012/05/12 GLENMARK PHARMS LTD
200694 004 ANDA LAMOTRIGINE LAMOTRIGINE TABLET;ORAL 200MG Prescription No No AB 2013/06/14 ALKEM LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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