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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1500535 托匹司他片 topiroxostat Tablet Chemical Drugs(3.1) New Drug Application 2015-11-04 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-11-09 view
CXHL1300247 头孢雷特 ceforanide Active ingredient Chemical Drugs(3.1) New Drug Application 2014-01-03 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-01-21 view
CXHL1500537 丁酸氯维地平 clevidipine butyrate Active ingredient Chemical Drugs(3.1) New Drug Application 2016-08-15 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2017-06-28 view
CXHL1301321 左旋泮托拉唑钠 (L)-pantoprazole sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2014-06-18 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-03-10 view
CXHL1200328 氯苯扎利二钠片 lobenzarit disodium Tablet Chemical Drugs(3.1) New Drug Application 2012-09-20 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2017-08-21 view
CXHL1400677 注射用福沙匹坦二甲葡胺 fosaprepitant dimeglumine Lyophilized Chemical Drugs(3.1) New Drug Application 2014-12-25 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-04-18 view
CXHL1300246 注射用头孢匹林钠 cefapirin sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2013-08-16 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2015-12-30 view
CXHL1500526 盐酸考来维仑干混悬剂 colesevelam hydrochloride Suspension Chemical Drugs(3.1) New Drug Application 2015-12-30 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2017-06-28 view
CXHL1300590 甘油磷酰胆碱注射液 choline alfoscerate Injection Chemical Drugs(3.1) New Drug Application 2014-02-24 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2015-12-15 view
CXHL1200423 奥美拉唑干混悬剂 omeprazole Suspension Chemical Drugs(3.1) New Drug Application 2012-09-17 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd In Approval 2015-09-28 view
CXHL1400345 注射用替莫西林钠 temocillin sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2014-12-25 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-06-20 view
CXHL1300417 非诺贝酸片 fenofibric acid Tablet Chemical Drugs(3.1) New Drug Application 2013-07-11 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2015-12-24 view
CXHL1500539 丁酸氯维地平注射液 clevidipine butyrate Injection Chemical Drugs(3.1) New Drug Application 2016-08-15 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2017-06-28 view
CXHL1301322 注射用左旋泮托拉唑钠 (L)-pantoprazole sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2014-05-26 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-02-29 view
CXHL1200326 氯苯扎利二钠 lobenzarit disodium Active ingredient Chemical Drugs(3.1) New Drug Application 2012-09-20 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2017-08-21 view
CXHL1400678 注射用福沙匹坦二甲葡胺 fosaprepitant dimeglumine Lyophilized Chemical Drugs(3.1) New Drug Application 2014-12-25 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-04-18 view
CXHL1300244 头孢匹林钠 cefapirin sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2013-08-14 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-01-14 view
CXHL1500524 盐酸考来维仑 colesevelam hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2015-12-30 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2017-06-28 view
CXHL1300962 注射用替卡西林钠克拉维酸钾(30:1) potassium clavulanate;ticarcillin sodium Lyophilized Chemical Drugs(3.2) New Drug Application 2014-01-03 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-01-21 view
CXHL1301291 富马酸尼唑苯酮注射液 Nizofenone fumarate Injection Chemical Drugs(3.1) New Drug Application 2014-12-25 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-03-25 view