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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL0502263 米格列奈片 mitiglinide Tablet Chemical Drugs(3.1) New Drug Application 2006-01-05 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2008-07-15 view
CXHL0502262 米格列奈 mitiglinide Active ingredient Chemical Drugs(3.1) New Drug Application 2006-01-05 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2008-07-15 view
CXHL0502189 盐酸度洛西汀 duloxetine hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2006-01-05 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2008-07-22 view
CXHL0502190 盐酸度洛西汀肠溶微丸胶囊 duloxetine hydrochloride Capsule Chemical Drugs(3.1) New Drug Application 2006-01-05 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2008-07-22 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
CXHL0500215 注射用伏立康唑 voriconazole Lyophilized Chemical Drugs(3.1) New Drug Application 2005-02-21 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2006-08-04 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
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
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
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
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
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
CXL20022626 盐酸尼非卡兰 Nifekalant Hydrochloride Active ingredient Chemical Drugs(2) New Drug Application 2003-12-03 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-03-12 view
CXL20022627 注射用盐酸尼非卡兰 Nifekalant Hydrochloride Lyophilized Chemical Drugs(2) New Drug Application 2003-12-03 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-03-12 view
CXL20022936 注射用雷替曲塞 raltitrexed Lyophilized Chemical Drugs(2) New Drug Application 2003-11-11 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-04-02 view
CXL20022935 雷替曲塞 raltitrexed Active ingredient Chemical Drugs(2) New Drug Application 2003-11-11 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-04-02 view