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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1500538 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
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
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
CXHL1500525 盐酸考来维仑片 colesevelam hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2016-01-05 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2017-06-28 view
CXHL1500527 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
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
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
CXHL1500532 托匹司他 topiroxostat Active ingredient Chemical Drugs(3.1) New Drug Application 2015-11-06 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-11-09 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
CXHL1500534 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
CXHL1500533 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
CXHL1402284 盐酸阿考替胺 acotiamide hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2015-05-22 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-08-12 view
CXHL1402285 盐酸阿考替胺片 acotiamide hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2015-05-22 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-08-12 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
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
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
CXHL1400676 福沙匹坦二甲葡胺 fosaprepitant dimeglumine Active ingredient 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
CXHL1400346 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
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
CXHL1400344 替莫西林钠 temocillin sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2014-12-24 济南康和医药科技有限公司 Jinan KangHe Pharmaceutical Technology Co Ltd Certificate Issued 2016-05-31 view