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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSB2400023 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2024-03-04 view
JXSB2400011 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2024-02-02 view
JXSL2400011 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Import Drug Application 2024-01-10 view
JXSB2300103 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2023-08-24 view
JXSL2300149 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Import Drug Application 2023-08-02 view
JXSB2300086 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2023-07-08 view
JXSB2300066 注射用德曲妥珠单抗(DS-8201a) trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2023-05-31 view
JXSB2200120 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2022-09-19 view
JXSB2200068 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2022-06-13 view
JXSB2200044 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2022-04-22 view
JXSB2200012 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2022-01-25 view
JXSB2101102 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2021-12-07 view
JXSB2101068 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2021-10-19 view
JTS2100530 Trastuzumab deruxtecan (DS-8201a, T-DXd ) 原液 trastuzumab deruxtecan Lyophilized Biological Products Disposable Import Drug Application 2021-10-11 view
JTS2100529 注射用Trastuzumab deruxtecan (DS-8201a, T-DXd ) trastuzumab deruxtecan Lyophilized Biological Products Disposable Import Drug Application 2021-10-11 view
JXSL2101093 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Import Drug Application 2021-08-13 view
JXSL2101086 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Import Drug Application 2021-08-03 view
JXSL2101064 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Import Drug Application 2021-07-02 view
JXSB2101024 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Supplementary Application 2021-06-15 view
JXSL2100011 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products(2.2) Import Drug Application 2021-01-25 Daiichi Sankyo, Inc. Daiichi Sankyo Co Ltd In Review 2021-01-25 view