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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1600144 丙氨酸布立尼布 brivanib alaninate Active ingredient Chemical Drugs(1) New Drug Application 2016-07-15 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-03-07 view
CXHL1600146 丙氨酸布立尼布片 brivanib alaninate Tablet Chemical Drugs(1) New Drug Application 2016-07-15 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-03-07 view
CXHL1501574 ZL-2102胶囊 ZL-2102 Capsule Chemical Drugs(1.1) New Drug Application 2015-08-24 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-04-17 view
CXHL1501571 ZL-2102 ZL-2102 Active ingredient Chemical Drugs(1.1) New Drug Application 2015-08-24 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-04-17 view
CXHL1501572 ZL-2102胶囊 ZL-2102 Capsule Chemical Drugs(1.1) New Drug Application 2015-08-24 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-04-17 view
CXHL1501573 ZL-2102胶囊 ZL-2102 Capsule Chemical Drugs(1.1) New Drug Application 2015-08-24 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-04-17 view
CXHL1600122 ZL-2303片 olmutinib Tablet Chemical Drugs(1.1) New Drug Application 2016-05-13 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-07-17 view
CXHL1600123 ZL-2303片 olmutinib Tablet Chemical Drugs(1.1) New Drug Application 2016-05-13 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-07-17 view
CXHL1600121 ZL-2303盐酸盐 olmutinib hydrochloride Active ingredient Chemical Drugs(1.1) New Drug Application 2016-05-13 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-07-17 view
CXHL1600344 ZL-2306胶囊 niraparib tosylate Capsule Chemical Drugs(1) New Drug Application 2017-03-01 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-07-24 view
CXHL1700045 ZL-2302 ZL-2302 Active ingredient Chemical Drugs(1) New Drug Application 2017-03-31 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2017-10-17 view
JXHL1900112 注射用ETX2514SUL ETX2514SUL Lyophilized Chemical Drugs(1) Import Drug Application 2019-05-22 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-05-21 view
CXHB1900068 ZL-2306胶囊 niraparib tosylate Capsule Chemical Drugs Supplementary Application 2019-11-15 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-14 view
JXSL1900118 INCMGA00012注射液 retifanlimab Injection Biological Products Import Drug Application 2019-11-16 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-15 view
JXSL1900115 Margetuximab注射液 margetuximab Injection Biological Products Import Drug Application 2019-11-16 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-15 view
JXSL1900114 MGD013注射液 tebotelimab Injection Biological Products Import Drug Application 2019-11-16 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-15 view
JXSL1900113 Margetuximab注射液 margetuximab Injection Biological Products Import Drug Application 2019-11-16 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-15 view
JXSL1900119 INCMGA00012注射液 retifanlimab Injection Biological Products Import Drug Application 2019-11-16 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-15 view
JXSL1900116 MGD013注射液 tebotelimab Injection Biological Products Import Drug Application 2019-11-28 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-27 view
CXHL1900376 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) New Drug Application 2019-11-29 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-28 view