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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB2000126 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
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
CXSB2000085 ZL-1201注射液 ZL-1201 Injection Biological Products(1) Supplementary Application 2020-11-02 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-10-30 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
CYHB2008100 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(2.4) Supplementary Application 2020-10-26 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-10-23 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
JXSL2000107 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
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
JXSL2000105 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
JXSL2000087 INCMGA00012注射液 retifanlimab 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
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
JXSL2000108 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
JXSL2000083 INCMGA00012注射液 retifanlimab Injection Biological Products Import Drug Application 2020-06-30 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-06-29 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
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
JXHL2000093 Ripretinib片 ripretinib Tablet Chemical Drugs(1) Import Drug Application 2020-05-10 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-05-09 view
CXSL2000096 ZL-1201注射液 ZL-1201 Injection Biological Products(1) New Drug Application 2020-05-09 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-05-08 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
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
CXHS2000002 ZL-2401对甲苯磺酸盐片 omadacycline tosylate Tablet Chemical Drugs(1) New Drug Application 2020-02-14 上海宣泰海门药业有限公司,再鼎医药(上海)有限公司 Certificate Issued 2021-12-17 view