药品注册申请号:078009
申请类型:ANDA (仿制药申请)
申请人:ZYDUS PHARMS USA INC
申请人全名:--
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, CHEWABLE; ORAL 2MG No No None 2009/01/22 -- Prescription
002 LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG No No AB 2009/01/22 Prescription
003 LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG No No AB 2009/01/22 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
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
2022/06/10 SUPPL-29(补充) Approval Labeling STANDARD
2022/06/10 SUPPL-28(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-27(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-26(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-25(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-24(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-23(补充) Approval Labeling STANDARD
2015/12/11 SUPPL-19(补充) Approval Labeling STANDARD
2015/12/11 SUPPL-18(补充) Approval Labeling STANDARD
2015/12/11 SUPPL-17(补充) Approval Labeling STANDARD
2015/12/11 SUPPL-16(补充) Approval Labeling STANDARD
2014/09/26 SUPPL-15(补充) Approval Labeling STANDARD
2014/09/26 SUPPL-12(补充) Approval Labeling STANDARD
2014/09/26 SUPPL-10(补充) Approval Labeling STANDARD
2012/03/14 SUPPL-9(补充) Approval Labeling
2012/03/14 SUPPL-8(补充) Approval Labeling
2012/03/07 SUPPL-7(补充) Approval REMS
2011/09/29 SUPPL-6(补充) Approval Labeling
2011/04/25 SUPPL-5(补充) Approval Labeling
2010/06/23 SUPPL-4(补充) Approval Labeling
2010/06/23 SUPPL-3(补充) Approval Labeling
2010/06/23 SUPPL-1(补充) Approval Labeling
2009/01/22 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
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:LAMOTRIGINE 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL 规格:5MG 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
020764 001 NDA LAMICTAL CD LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription Yes No AB 1998/08/24 GLAXOSMITHKLINE LLC
076701 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription No No AB 2009/01/22 DR REDDYS LABS LTD
076928 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription No No AB 2009/01/22 WATSON LABS
078009 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription No No AB 2009/01/22 ZYDUS PHARMS USA INC
079204 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription No No AB 2009/02/04 TARO
079099 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription No No AB 2009/02/19 GLENMARK PHARMS LTD
090401 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription No No AB 2009/11/04 AUROBINDO PHARMA
201168 001 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 5MG Prescription No No AB 2014/06/12 ALEMBIC
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET, FOR SUSPENSION;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
020764 002 NDA LAMICTAL CD LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription Yes Yes AB 1998/08/24 GLAXOSMITHKLINE LLC
076701 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription No No AB 2009/01/22 DR REDDYS LABS LTD
076928 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription No No AB 2009/01/22 WATSON LABS
078009 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription No No AB 2009/01/22 ZYDUS PHARMS USA INC
079204 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription No No AB 2009/02/04 TARO
079099 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription No No AB 2009/02/19 GLENMARK PHARMS LTD
090401 003 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription No No AB 2009/11/04 AUROBINDO PHARMA
201168 002 ANDA LAMOTRIGINE LAMOTRIGINE TABLET, FOR SUSPENSION;ORAL 25MG Prescription No No AB 2014/06/12 ALEMBIC
更多信息
药品NDC数据与药品包装、标签说明书
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