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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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