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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1700081 CK15 CK15 Active ingredient Chemical Drugs(1) New Drug Application 2017-07-20 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2017-12-21 view
CXHL1700084 CK15软胶囊 CK15 Capsule Chemical Drugs(1) New Drug Application 2017-07-20 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2017-12-21 view
CXHL1700083 CK15软胶囊 CK15 Capsule Chemical Drugs(1) New Drug Application 2017-07-20 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2017-12-21 view
CXHL1700082 CK15软胶囊 CK15 Capsule Chemical Drugs(1) New Drug Application 2017-07-20 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2017-12-21 view
CXHL2100219 CK21脂肪乳注射液 CK-21 Injection Chemical Drugs(1) New Drug Application 2021-04-07 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd In Review 2021-04-06 view
CXHB1800052 替诺福韦十八烷氧乙酯 Active ingredient Chemical Drugs Supplementary Application 2018-07-26 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd In Review 2018-08-13 view
CXHL1500460 替诺福韦十八烷氧乙酯 Active ingredient Chemical Drugs(1.1) New Drug Application 2015-07-17 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2017-02-21 view
CXHL1500461 替诺福韦十八烷氧乙酯片 Tablet Chemical Drugs(1.1) New Drug Application 2015-07-17 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2017-02-21 view
CXHB1800055 替诺福韦十八烷氧乙酯片 Tablet Chemical Drugs Supplementary Application 2018-07-26 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2018-10-22 view
CXHB1800054 替诺福韦十八烷氧乙酯片 Tablet Chemical Drugs Supplementary Application 2018-07-26 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2018-10-22 view
CXHB1800053 替诺福韦十八烷氧乙酯片 Tablet Chemical Drugs Supplementary Application 2018-07-26 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2018-10-22 view
CXHL1501107 特立氟胺 teriflunomide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-11-10 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2016-10-24 view
CXHL1501108 特立氟胺片 teriflunomide Tablet Chemical Drugs(3.1) New Drug Application 2015-11-10 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2016-10-24 view
CXHL1501109 特立氟胺片 teriflunomide Tablet Chemical Drugs(3.1) New Drug Application 2015-11-10 欣凯医药化工中间体(上海)有限公司 Xinkai Medicine and Chemical Intermediates (Shanghai) Co Ltd Certificate Issued 2016-10-24 view