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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0407881 复方特比萘芬乳膏 Cream Chemical Drugs(1.5) New Drug Application 2004-12-22 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2005-06-24 view
X0404233 布洛伪麻那敏胶囊 chlorphenamine maleate;ibuprofen;pseudoephedrine hydrochloride Capsule Chemical Drugs(3.2) New Drug Application 2004-07-29 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2005-07-29 view
X0404231 布洛伪麻那敏片 chlorphenamine maleate;ibuprofen;pseudoephedrine hydrochloride Tablet Chemical Drugs(3.2) New Drug Application 2004-07-29 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2005-08-26 view
X0403242 格列吡嗪盐酸二甲双胍缓释片 glipizide;metformin hydrochloride Tablet, extended release Chemical Drugs(3.2) New Drug Application 2004-06-16 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2006-05-15 view
X0400601 普卢利沙星胶囊 prulifloxacin Capsule Chemical Drugs(3.1) New Drug Application 2004-09-30 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-31 view
X0400600 普卢利沙星片 prulifloxacin Tablet Chemical Drugs(3.1) New Drug Application 2004-09-30 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-31 view
X0400599 普卢利沙星 prulifloxacin Active ingredient Chemical Drugs(3.1) New Drug Application 2004-09-30 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-31 view
X0306247 格列吡嗪盐酸二甲双胍肠溶片 glipizide;metformin hydrochloride Tablet Chemical Drugs(3.2) New Drug Application 2004-11-19 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2005-02-08 view
X0306234 法罗培南钠片 faropenem sodium Tablet Chemical Drugs(3.1) New Drug Application 2004-08-09 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-11-26 view
X0306233 法罗培南钠颗粒 faropenem sodium Granule Chemical Drugs(3.1) New Drug Application 2004-08-09 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-11-26 view
X0306232 法罗培南钠 faropenem sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-08-09 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-11-26 view
X0305870 格列吡嗪盐酸二甲双胍片 glipizide;metformin hydrochloride Tablet Chemical Drugs(3.2) New Drug Application 2004-09-21 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-16 view
X0305869 格列吡嗪盐酸二甲双胍片 glipizide;metformin hydrochloride Tablet Chemical Drugs(3.2) New Drug Application 2004-09-21 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-16 view
X0305868 格列吡嗪盐酸二甲双胍片 glipizide;metformin hydrochloride Tablet Chemical Drugs(3.2) New Drug Application 2004-09-21 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-16 view
X0305861 注射用硫酸头孢噻利 Cefoselis Sulfate Lyophilized Chemical Drugs(3.1) New Drug Application 2004-09-24 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-20 view
X0305860 硫酸头孢噻利 Cefoselis Sulfate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-09-24 海南国栋药物研究所有限公司 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-17 view
X0304988 巴洛沙星胶囊 balofloxacin Capsule Chemical Drugs(3.1) New Drug Application 2004-07-19 海南国栋药物研究所 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-11-22 view
X0304987 巴洛沙星片 balofloxacin Tablet Chemical Drugs(3.1) New Drug Application 2004-07-19 海南国栋药物研究所 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-11-22 view
X0304986 巴洛沙星 balofloxacin Active ingredient Chemical Drugs(3.1) New Drug Application 2004-07-19 海南国栋药物研究所 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-11-22 view
X0302126 塞克硝唑阴道泡腾片 secnidazole Tablet Chemical Drugs(2) New Drug Application 2003-04-22 海南国栋药物研究所 Hainan Guodong Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-08-10 view