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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
CXHL1200422 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
CXHL1301290 富马酸尼唑苯酮 Nizofenone fumarate 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 2016-03-25 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
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
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
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
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
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
CXHL1200327 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
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
CXHL1300245 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