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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1300111 重组抗CD20人源化单克隆抗体注射液 Recombinant anti-CD20 humanized monoclonal antibody Injection Biological Products(2) New Drug Application 2014-05-12 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-08-23 view
CXHL1401771 醋酸艾司利卡西平片 eslicarbazepine acetate Tablet Chemical Drugs(3.1) New Drug Application 2015-02-03 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-05-19 view
CXHL1401770 醋酸艾司利卡西平 eslicarbazepine acetate Active ingredient Chemical Drugs(3.1) New Drug Application 2015-02-03 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-05-12 view
CXHL1500492 SPH3127 I-001 Active ingredient Chemical Drugs(1.1) New Drug Application 2015-06-03 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-05-04 view
CXHL1500495 SPH3127片 I-001 Tablet Chemical Drugs(1.1) New Drug Application 2015-06-03 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-05-04 view
CXHL1501800 拉科酰胺 lacosamide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-09-25 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-08-23 view
CXHL1600095 SPH1188-11片 SPH1188-11 Tablet Chemical Drugs(1.1) New Drug Application 2016-04-20 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-12-08 view
CXHL1600093 SPH1188-11 SPH1188-11 Active ingredient Chemical Drugs(1.1) New Drug Application 2016-04-20 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-12-08 view
CXHL1600094 SPH1188-11片 SPH1188-11 Tablet Chemical Drugs(1.1) New Drug Application 2016-04-20 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2016-12-08 view
CXSL1600070 注射用重组抗HER2人源化单克隆抗体组合物 B-002 Lyophilized Biological Products(1) New Drug Application 2017-02-13 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2017-09-27 view
CXHL1700109 羟基雷公藤内酯醇片 5-Hydroxytriptolide Tablet Chemical Drugs(1) New Drug Application 2017-07-03 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Approval Completed-Pending Certificated 2018-02-01 view
CXHL1700108 羟基雷公藤内酯醇片 5-Hydroxytriptolide Tablet Chemical Drugs(1) New Drug Application 2017-07-03 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Approval Completed-Pending Certificated 2018-02-01 view
CXHL1700226 SPH3348片 SPH3348 Tablet Chemical Drugs(1) New Drug Application 2017-11-23 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2018-04-27 view
CXHL1700227 SPH3348片 SPH3348 Tablet Chemical Drugs(1) New Drug Application 2017-11-23 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2018-04-27 view
CXHL1700225 SPH3348 SPH3348 Active ingredient Chemical Drugs(1) New Drug Application 2017-11-24 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd In Review 2017-11-22 view
CXHL1700289 SPH4480片 SPH4480 Tablet Chemical Drugs(1) New Drug Application 2018-06-28 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd In Review 2018-06-26 view
CXHL1700288 SPH4480片 SPH4480 Tablet Chemical Drugs(1) New Drug Application 2018-06-28 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd In Review 2018-06-26 view
CXHL1700287 SPH4480 SPH4480 Active ingredient Chemical Drugs(1) New Drug Application 2018-06-28 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd In Review 2018-06-26 view
CYHB1940030 卡马西平片 carbamazepine Tablet Chemical Drugs Supplementary Application 2019-06-03 上海医药集团青岛国风药业股份有限公司,上海医药集团股份有限公司 Certificate Issued 2021-12-01 view
CXHL2000137 SPH4336片 SPH4336 Tablet Chemical Drugs(1) New Drug Application 2020-03-31 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd In Review 2020-03-30 view