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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHS1100081 达托霉素 daptomycin Active ingredient Chemical Drugs(3.1) New Drug Application 2011-11-10 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2015-11-19 view
CYHS1201621 吗替麦考酚酯 mycophenolate mofetil Active ingredient Chemical Drugs(6) Generic Drug 2013-04-12 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2017-10-20 view
CXSL1500025 重组抗白介素-6受体人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-05-05 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2016-11-09 view
CXSL1600073 德谷胰岛素注射液 insulin degludec Injection Biological Products(7) New Drug Application 2016-10-08 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2017-12-21 view
CXSL1700097 注射用重组抗IgE人源化单克隆抗体 Lyophilized Biological Products(2) New Drug Application 2017-10-19 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2018-10-22 view
CXSL1800028 重组抗PD-L1全人源单克隆抗体注射液 Recombinant anti-PD-L1 human monoclonal antibody Injection Biological Products(1) New Drug Application 2018-03-26 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2018-08-07 view
CXSB2000040 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(原2) Supplementary Application 2020-08-12 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2020-12-09 view