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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1700081 RC28-E注射液 RC28-E Injection Biological Products(1) New Drug Application 2017-08-24 荣昌生物制药(烟台)有限公司 RemeGen Co Ltd Certificate Issued 2018-05-30 view
CXSL1900051 注射用RC98 RC98 Lyophilized Biological Products(1) New Drug Application 2019-05-29 荣昌生物制药(烟台)有限公司 RemeGen Co Ltd In Review 2019-05-28 view
CXSL1800066 注射用RC88 RC88 Lyophilized Biological Products(1) New Drug Application 2018-06-04 荣昌生物制药(烟台)有限公司 RemeGen Co Ltd In Review 2018-05-31 view
CXSL1700191 注射用重组人B淋巴细胞刺激因子受体-抗体融合蛋白 Lyophilized Biological Products(1) New Drug Application 2018-01-08 荣昌生物制药(烟台)有限公司 RemeGen Co Ltd Certificate Issued 2018-06-08 view
CXSB2000012 RC28-E注射液 RC28-E Injection Biological Products Supplementary Application 2020-05-10 荣昌生物制药(烟台)有限公司 RemeGen Co Ltd In Review 2020-05-09 view
CXSL1700080 RC28-E注射液 RC28-E Injection Biological Products(1) New Drug Application 2017-08-24 荣昌生物制药(烟台)有限公司 RemeGen Co Ltd Certificate Issued 2018-05-30 view
CXSS1900040 注射用泰它西普 telitacicept Lyophilized Biological Products(1) New Drug Application 2019-11-13 荣昌生物制药(烟台)有限公司 RemeGen Co Ltd Certificate Issued 2021-03-16 view