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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0407622 盐酸氨溴索口腔崩解片 ambroxol hydrochloride Tablet Chemical Drugs(5) New Drug Application 2004-12-16 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-06-23 view
X0407604 盐酸氨溴索分散片 ambroxol hydrochloride Tablet Chemical Drugs(5) New Drug Application 2004-12-16 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-06-17 view
X0405287 注射用兰索拉唑 lansoprazole Lyophilized Chemical Drugs(3.1) New Drug Application 2004-09-16 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry;Jiangsu Aosaikang Pharmaceutical Co Ltd Certificate Issued 2005-03-21 view
X0405146 盐酸昂丹司琼口腔崩解片 ondansetron hydrochloride Tablet Chemical Drugs(5) New Drug Application 2004-09-13 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry;Jiangsu Aosaikang Pharmaceutical Co Ltd Certificate Issued 2005-04-01 view
X0404094 巴洛沙星胶囊 balofloxacin Capsule Chemical Drugs(3.1) New Drug Application 2004-07-25 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry;Jiangsu Aosaikang Pharmaceutical Co Ltd Certificate Issued 2005-01-07 view
X0404090 草酸艾司西酞普兰片 escitalopram oxalate Tablet Chemical Drugs(3.1) New Drug Application 2004-07-25 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-27 view
X0404089 草酸艾司西酞普兰 escitalopram oxalate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-07-25 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-27 view
X0404083 盐酸美金刚片 memantine hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2004-07-25 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-14 view
X0404082 盐酸美金刚 memantine hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2004-07-25 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-17 view
X0404035 醋酸亮丙瑞林注射液 leuprorelin acetate Injection Chemical Drugs(3.1) New Drug Application 2004-07-21 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry;Yangzhou Aosaikang Pharmaceutical Co Ltd Certificate Issued 2005-07-15 view
X0404034 醋酸亮丙瑞林 leuprorelin acetate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-07-21 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry;Yangzhou Aosaikang Pharmaceutical Co Ltd Certificate Issued 2005-07-15 view
X0404031 甲磺酸加替沙星分散片 gatifloxacin mesylate Tablet Chemical Drugs(5) New Drug Application 2004-07-21 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-28 view
X0402306 普卢利沙星胶囊 prulifloxacin Capsule Chemical Drugs(3.1) New Drug Application 2004-10-14 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-14 view
X0402065 伏立康唑片 voriconazole Tablet Chemical Drugs(3.1) New Drug Application 2005-01-12 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-04-01 view
X0402064 注射用伏立康唑 voriconazole Lyophilized Chemical Drugs(3.1) New Drug Application 2005-01-12 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry;Yangzhou Aosaikang Pharmaceutical Co Ltd Certificate Issued 2005-04-01 view
X0402063 伏立康唑 voriconazole Active ingredient Chemical Drugs(3.1) New Drug Application 2005-01-12 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-04-01 view
X0401284 吗替麦考酚酯分散片 mycophenolate mofetil Tablet Chemical Drugs(5) New Drug Application 2004-03-16 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry;Jiangsu Aosaikang Pharmaceutical Co Ltd Certificate Issued 2004-11-26 view
X0401098 磷苯妥英钠注射液 fosphenytoin sodium Injection Chemical Drugs(3.1) New Drug Application 2004-12-02 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-02-04 view
X0400208 普卢利沙星片 prulifloxacin Tablet Chemical Drugs(3.1) New Drug Application 2004-10-11 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-07 view
X0400207 普卢利沙星 prulifloxacin Active ingredient Chemical Drugs(3.1) New Drug Application 2004-10-11 南京海光应用化学研究所 Nanjing Haiguang Institute of Applied Chemistry Certificate Issued 2005-01-07 view