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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
CXL01C82G 西尼地平 cilnidipine Active ingredient 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
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
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
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
CXL01E65 氯雷他定胶囊 loratadine Capsule 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
CXL01M01 西尼地平胶囊 cilnidipine 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 2003-08-25 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
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
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
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
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
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
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
CXL20020465 盐酸托烷司琼注射液 tropisetron hydrochloride Injection 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 2003-06-20 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
CXL20020467 盐酸尼莫司汀 nimustine hydrochloride Active ingredient 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