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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXS01547 门冬氨酸钾镁氯化钠注射液 Magnesium aspartate;Potassium Aspartate Injection Chemical Drugs(4) New Drug Application 2001-10-24 西安海欣制药有限公司山东基恩医药研究有限公司 Certificate Issued 2003-08-25 view
CXS01722 硝酸异山梨酯葡萄糖注射液 isosorbide dinitrate Injection Chemical Drugs(4) New Drug Application 2001-12-14 河南竹林众生制药股份有限公司山东基恩医药研究有限公司 Certificate Issued 2003-09-15 view
CXS20020064 盐酸多巴胺葡萄糖注射液 dopamine hydrochloride Injection Chemical Drugs(4) New Drug Application 2002-02-26 山东基恩医药研究有限公司青州尧王制药有限公司 Certificate Issued 2003-08-12 view
CXS20020396 胞磷胆碱钠葡萄糖注射液 citicoline sodium Injection Chemical Drugs(4) New Drug Application 2002-05-22 山东基恩医药研究有限公司湖南科伦制药有限公司 Certificate Issued 2003-11-24 view
CXS20020393 胞磷胆碱钠葡萄糖注射液 citicoline sodium Injection Chemical Drugs(4) New Drug Application 2002-05-22 山东基恩医药研究有限公司湖南科伦制药有限公司 Certificate Issued 2003-11-24 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
CXS01171 门冬氨酸钾镁葡萄糖注射液 Magnesium aspartate;Potassium Aspartate Injection Chemical Drugs(4) New Drug Application 2001-04-13 山东基恩医药研究有限公司河南竹林众生制药股份有限公司 Approval Completed-Pending Certificated 2002-07-24 view
CXS20020629 注射用苦参碱 Matrine Lyophilized Chemical Drugs(4) New Drug Application 2002-08-01 山东基恩医药研究有限公司沈阳新马药业有限公司 Certificate Issued 2003-11-03 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
CXL01C83G 西尼地平片 cilnidipine Tablet Chemical Drugs(2) New Drug Application 2001-12-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-09-05 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
CXL20022939 甲磺酸帕珠沙星 pazufloxacin mesylate Active ingredient Chemical Drugs(2) New Drug Application 2003-10-21 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-03-05 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
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
CXL20020468 注射用盐酸尼莫司汀 nimustine hydrochloride Lyophilized Chemical Drugs(4) New Drug Application 2002-03-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-07-21 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
CXL20022933 注射用盐酸多西环素 doxycycline hyclate Lyophilized Chemical Drugs(4) New Drug Application 2002-11-13 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-08-25 view
CXL01E64 氯雷他定片 loratadine Tablet Chemical Drugs(4) 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 2003-01-30 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