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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2500058 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2025-06-04 RemeGen Co Ltd view
CYSB2500043 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(1) Supplementary Application 2025-02-18 RemeGen Co Ltd view
CXSS2400111 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2024-10-15 RemeGen Co Ltd view
CXSL2400306 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2024-05-11 RemeGen Co Ltd view
CXSL2400037 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.1;2.2) New Drug Application 2024-01-18 RemeGen Co Ltd view
CYSB2300215 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(1) Supplementary Application 2023-11-25 RemeGen Co Ltd view
CXSL2300686 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2023-10-12 RemeGen Co Ltd view
CXSL2300486 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2023-07-18 RemeGen Co Ltd view
CXSL2300459 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2023-07-11 RemeGen Co Ltd view
CYSB2300118 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(1) Supplementary Application 2023-06-19 RemeGen Co Ltd view
CXSL2300319 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2023-05-08 RemeGen Co Ltd view
CXSL2300048 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2023-01-18 RemeGen Co Ltd view
CXSL2300018 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2023-01-07 RemeGen Co Ltd view
CXSL2300019 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.1;2.2) New Drug Application 2023-01-07 RemeGen Co Ltd view
CXSL2300017 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2023-01-06 RemeGen Co Ltd view
CXSL2200632 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2022-12-31 RemeGen Co Ltd view
CXSL2200633 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2022-12-31 RemeGen Co Ltd view
CXSL2200559 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2022-11-05 RemeGen Co Ltd view
CXSL2200515 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products(2.2) New Drug Application 2022-10-13 RemeGen Co Ltd view
CYSB2200122 注射用维迪西妥单抗 disitamab vedotin Lyophilized Biological Products Supplementary Application 2022-05-19 RemeGen Co Ltd view