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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0404712 伏立康唑 voriconazole Active ingredient Chemical Drugs(3.1) New Drug Application 2004-08-23 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-06-24 view
X0404713 伏立康唑片 voriconazole Tablet Chemical Drugs(3.1) New Drug Application 2004-08-23 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-06-24 view
CXHL0500396 伏立康唑胶囊 voriconazole Capsule Chemical Drugs(3.1) New Drug Application 2005-03-26 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-12-02 view
CXL01G11 利塞膦酸钠 risedronate sodium Active ingredient Chemical Drugs(2) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-08-01 view
CXL01G12 利塞膦酸钠片 risedronate sodium Tablet Chemical Drugs(2) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-08-01 view
CXL01G13 利塞膦酸钠胶囊 risedronate sodium Capsule Chemical Drugs(2) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-08-01 view
X0304914 利拉萘酯 liranaftate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-04-30 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-07-29 view
X0304915 利拉萘酯软膏 liranaftate Ointment Chemical Drugs(3.1) New Drug Application 2004-04-30 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-07-29 view
CXS01712 单硝酸异山梨酯葡萄糖注射液 isosorbide mononitrate Injection Chemical Drugs(4) New Drug Application 2001-12-14 山东基恩医药研究有限公司泰丰(江西)制药有限公司 Certificate Issued 2004-02-09 view
CXL20020976 复方氯雷他定缓释胶囊 loratadine;Pseudoephedrine Sulfate Capsules, extended release Chemical Drugs(4) New Drug Application 2004-02-13 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-07-05 view
CXL20021718 复方盐酸二甲双胍片 glibenclamide;metformin hydrochloride Tablet Chemical Drugs(4) New Drug Application 2002-07-30 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-06-06 view
CXL20022937 多非利特 dofetilide Active ingredient Chemical Drugs(2) New Drug Application 2003-12-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-05-28 view
CXL20022938 多非利特胶囊 dofetilide Capsule Chemical Drugs(2) New Drug Application 2003-12-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-05-28 view
CXL01M02 富马酸伊布利特 ibutilide fumarate Active ingredient Chemical Drugs(2) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Approval Completed-Pending Certificated 2003-03-07 view
CXL01M03 富马酸伊布利特注射液 ibutilide fumarate Injection Chemical Drugs(2) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Approval Completed-Pending Certificated 2003-03-07 view
X0401636 巴洛沙星 balofloxacin Active ingredient Chemical Drugs(3.1) New Drug Application 2005-01-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-04-11 view
X0401635 巴洛沙星片 balofloxacin Tablet Chemical Drugs(3.1) New Drug Application 2005-01-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-04-11 view
X0401637 巴洛沙星胶囊 balofloxacin Capsule Chemical Drugs(5) New Drug Application 2004-04-05 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-04-22 view
CXS20020053 氟康唑葡萄糖注射液 fluconazole Injection Chemical Drugs(4) New Drug Application 2002-02-26 通化东宝药业股份有限公司山东基恩医药研究有限公司 Certificate Issued 2004-02-23 view
CXL01E63 氯雷他定 loratadine Active ingredient Chemical Drugs(4) New Drug Application 2002-01-21 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Approval Completed-Pending Certificated 2003-01-30 view