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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
B20000038 拉莫三嗪 lamotrigine Active ingredient Chemical Drugs Import Drug Application 2000-01-01 葛兰素威康中国公司北京办事处 Glaxosmithkline Beijing;The Wellcome Foundation Ltd;Glaxo Operations UK Ltd Approval Completed-Pending Certificated 2000-05-06 view
CXHL0900230 拉莫三嗪片 lamotrigine Tablet Chemical Drugs(3.4) New Drug Application 2009-07-27 三金集团湖南三金制药有限责任公司 Sanjin Group Hunan Sanjin Pharmaceutical Co Ltd Certificate Issued 2010-04-16 view
CXHL1301046 拉莫三嗪控释片 lamotrigine Tablet, extended release Chemical Drugs(5) New Drug Application 2014-04-17 浙江华海药业股份有限公司 Zhe JIANG HUA HAI Pharmaceutical Co Ltd Certificate Issued 2016-01-28 view
CXHL1301047 拉莫三嗪控释片 lamotrigine Tablet, extended release Chemical Drugs(5) New Drug Application 2014-04-17 浙江华海药业股份有限公司 Zhe JIANG HUA HAI Pharmaceutical Co Ltd Certificate Issued 2016-01-28 view
CXHL1301048 拉莫三嗪控释片 lamotrigine Tablet, extended release Chemical Drugs(5) New Drug Application 2014-04-17 浙江华海药业股份有限公司 Zhe JIANG HUA HAI Pharmaceutical Co Ltd Certificate Issued 2016-01-28 view
CXHL1301049 拉莫三嗪控释片 lamotrigine Tablet, extended release Chemical Drugs(5) New Drug Application 2014-04-17 浙江华海药业股份有限公司 Zhe JIANG HUA HAI Pharmaceutical Co Ltd Certificate Issued 2016-01-28 view
CXHL1301050 拉莫三嗪控释片 lamotrigine Tablet, extended release Chemical Drugs(5) New Drug Application 2014-04-17 浙江华海药业股份有限公司 Zhe JIANG HUA HAI Pharmaceutical Co Ltd Certificate Issued 2016-01-28 view
CXHL1301051 拉莫三嗪控释片 lamotrigine Tablet, extended release Chemical Drugs(5) New Drug Application 2014-04-17 浙江华海药业股份有限公司 Zhe JIANG HUA HAI Pharmaceutical Co Ltd Certificate Issued 2016-01-28 view
CXHL1500345 拉莫三嗪缓释片 lamotrigine Tablet, extended release Chemical Drugs(5) New Drug Application 2015-04-30 泰州越洋医药开发有限公司 Taizhou Overseas Pharmaceuticals Co Ltd Certificate Issued 2016-02-29 view
CXHL1500766 拉莫三嗪口服冻干片 lamotrigine Lyophilized Chemical Drugs(5) New Drug Application 2015-07-30 陕西量子高科药业有限公司 Shaanxi Quantum Hi Tech Pharmacy Co Ltd Certificate Issued 2016-04-18 view
CXHL1500767 拉莫三嗪口服冻干片 lamotrigine Lyophilized Chemical Drugs(5) New Drug Application 2015-07-30 陕西量子高科药业有限公司 Shaanxi Quantum Hi Tech Pharmacy Co Ltd Certificate Issued 2016-04-18 view
CXHL1700204 拉莫三嗪干混悬剂 lamotrigine Suspension Chemical Drugs(2.2) New Drug Application 2017-09-06 上海奥科达医药技术有限公司 Shanghai Aucta Pharmaceuticals Co Ltd Certificate Issued 2018-07-06 view
CXHL1900354 儿童用拉莫三嗪微片 lamotrigine Tablet Chemical Drugs(2.2) New Drug Application 2019-11-15 北京科信必成医药科技发展有限公司 CoSci Med-Tech Co Ltd In Review 2019-11-14 view
CXHS1500019 拉莫三嗪口服溶液 lamotrigine Oral solution Chemical Drugs(5) New Drug Application 2015-12-11 哈尔滨天地药业有限公司 Harbin Tiandi Pharmaceutical Co Ltd Certificate Issued 2017-09-05 view
CXHS1500020 拉莫三嗪口服溶液 lamotrigine Oral solution Chemical Drugs(5) New Drug Application 2015-12-11 哈尔滨天地药业有限公司 Harbin Tiandi Pharmaceutical Co Ltd Certificate Issued 2017-09-05 view
CXHS1500021 拉莫三嗪口服溶液 lamotrigine Oral solution Chemical Drugs(5) New Drug Application 2015-12-11 哈尔滨天地药业有限公司 Harbin Tiandi Pharmaceutical Co Ltd Certificate Issued 2017-09-05 view
CXS20020786 拉莫三嗪片 lamotrigine Tablet Chemical Drugs(4) New Drug Application 2002-09-02 天津药物研究院,湖南天健制药有限公司 Certificate Issued 2004-02-13 view
CXS20020787 拉莫三嗪 lamotrigine Active ingredient Chemical Drugs(4) New Drug Application 2002-09-02 天津药物研究院,湖南天健制药有限公司 Certificate Issued 2004-02-13 view
CYHB0701950 拉莫三嗪 lamotrigine Active ingredient Chemical Drugs Supplementary Application 2008-03-14 三金集团湖南三金制药有限责任公司 Sanjin Group Hunan Sanjin Pharmaceutical Co Ltd Certificate Issued 2008-08-13 view
CYHB0903019 拉莫三嗪 lamotrigine Active ingredient Chemical Drugs Supplementary Application 2009-04-28 三金集团湖南三金制药有限责任公司 Sanjin Group Hunan Sanjin Pharmaceutical Co Ltd Certificate Issued 2010-08-23 view