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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1900026 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-03-25 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd In Review 2019-03-22 view
CXSL1500131 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2016-02-25 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-09-28 view
CXSB2400010 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) Supplementary Application 2024-02-02 Shanghai Henlius Biopharmaceutical Co Ltd view
CXSL2101349 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2021-10-14 Shanghai Henlius Biotech Co Ltd view
CXSL2200077 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2022-02-10 Shanghai Henlius Biotech Co Ltd view
CXSB2200073 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) Supplementary Application 2022-09-17 Shanghai Henlius Biotech Co Ltd view