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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0400578 巴洛沙星胶囊 balofloxacin Capsule Chemical Drugs(3.1) New Drug Application 2004-02-11 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2004-10-15 view
X0400577 巴洛沙星 balofloxacin Active ingredient Chemical Drugs(3.1) New Drug Application 2004-02-11 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2004-10-15 view
X0403372 巴洛沙星分散片 balofloxacin Tablet Chemical Drugs(3.1) New Drug Application 2004-06-24 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2004-12-15 view
X0400623 巴洛沙星片 balofloxacin Tablet Chemical Drugs(3.1) New Drug Application 2004-09-20 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2004-12-15 view
X0401162 硫酸头孢噻利 Cefoselis Sulfate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-03-08 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2004-12-17 view
X0401163 注射用硫酸头孢噻利 Cefoselis Sulfate Lyophilized Chemical Drugs(3.1) New Drug Application 2004-03-08 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2004-12-17 view
X0403370 注射用尼可地尔 nicorandil Lyophilized Chemical Drugs(3.3) New Drug Application 2004-06-24 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2005-07-15 view
X0403369 注射用尼可地尔 nicorandil Lyophilized Chemical Drugs(3.3) New Drug Application 2004-06-24 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2005-07-15 view
X0408250 注射用阿仑膦酸钠 alendronate sodium Lyophilized Chemical Drugs(3.3) New Drug Application 2005-01-06 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2005-08-26 view
X0408246 阿仑膦酸钠注射液 alendronate sodium Injection Chemical Drugs(3.3) New Drug Application 2005-01-06 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2005-08-26 view
X0408245 阿仑膦酸钠注射液 alendronate sodium Injection Chemical Drugs(3.3) New Drug Application 2005-01-06 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2005-08-26 view
X0408251 注射用阿仑膦酸钠 alendronate sodium Lyophilized Chemical Drugs(3.3) New Drug Application 2005-01-06 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2005-08-26 view
CXHB0601171 阿仑膦酸钠注射液 alendronate sodium Injection Chemical Drugs Supplementary Application 2006-09-05 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2007-05-11 view
CXHB0700943 阿仑膦酸钠注射液 alendronate sodium Injection Chemical Drugs Supplementary Application 2007-08-30 济南恒瑞医药开发有限公司 Jinan Hengrui Pharmaceutical Development Co Ltd Certificate Issued 2008-05-22 view