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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHS2000003 注射用ZL-2401对甲苯磺酸盐 omadacycline tosylate Lyophilized Chemical Drugs(1) New Drug Application 2020-02-14 浙江海正药业股份有限公司,再鼎医药(上海)有限公司 Certificate Issued 2021-12-17 view
CYHB2008144 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) Supplementary Application 2020-10-27 再鼎医药(上海)有限公司,再鼎医药(苏州)有限公司 Certificate Issued 2021-10-25 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
JYHB2000581 注射用ETX2514SUL ETX2514SUL Lyophilized Chemical Drugs(1) Supplementary Application 2020-05-18 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-08-07 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
JXHS2000121 Ripretinib片 ripretinib Tablet Chemical Drugs(5.1) Import Drug Application 2020-07-22 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd Certificate Issued 2021-03-31 view
JXSL1900135 MGD013注射液 tebotelimab Injection Biological Products Import 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
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
JXSL2000031 MGD013注射液 tebotelimab Injection Biological Products Import Drug Application 2020-04-01 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-03-31 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
JXSL2000106 REGN1979注射液 odronextamab Injection Biological Products Import Drug Application 2020-07-03 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-07-02 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
CXHB2000125 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) Supplementary Application 2020-11-20 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-11-19 view
JXSL1900140 INCMGA00012注射液 retifanlimab Injection Biological Products Import Drug Application 2019-12-07 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-12-06 view
JYSB2000178 Margetuximab注射液 margetuximab Injection Biological Products Supplementary Application 2020-05-18 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-05-16 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
JXSL2000109 REGN1979注射液 odronextamab Injection Biological Products Import Drug Application 2020-07-03 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-07-02 view
JXSL1900134 MGD013注射液 tebotelimab Injection Biological Products Import 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
JYSB2000090 MGD013注射液 tebotelimab Injection Biological Products Supplementary Application 2020-03-27 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-03-26 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