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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2200101 注射用泰它西普 telitacicept Lyophilized Biological Products(2.2) New Drug Application 2022-02-23 RemeGen Co Ltd view
CXSL2200320 注射用泰它西普 telitacicept Lyophilized Biological Products(2.2) New Drug Application 2022-07-14 RemeGen Co Ltd 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
CXSS2300074 注射用泰它西普 telitacicept Lyophilized Biological Products(2.2) New Drug Application 2023-09-07 RemeGen Co Ltd view
CXSS2400115 注射用泰它西普 telitacicept Lyophilized Biological Products(2.2) New Drug Application 2024-10-26 RemeGen Co Ltd view
CYSB2101282 注射用泰它西普 telitacicept Lyophilized Biological Products Supplementary Application 2021-12-09 RemeGen Co Ltd view
CYSB2300008 注射用泰它西普 telitacicept Lyophilized Biological Products(1) Supplementary Application 2023-01-11 RemeGen Co Ltd view
CYSB2300009 注射用泰它西普 telitacicept Lyophilized Biological Products(1) Supplementary Application 2023-01-11 RemeGen Co Ltd view
CYSB2300125 注射用泰它西普 telitacicept Lyophilized Biological Products(2.2) Supplementary Application 2023-07-06 RemeGen Co Ltd view