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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2200045 拓培非格司亭注射液 telpegfilgrastim Injection Biological Products(1) New Drug Application 2022-04-29 Xiamen Amoytop Biotech Co Ltd view
CXSS2400006 怡培生长激素注射液 Injection Biological Products(1) New Drug Application 2024-01-11 Xiamen Amoytop Biotech Co Ltd view
CXSS2400023 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products(2.2) New Drug Application 2024-03-16 Xiamen Amoytop Biotech Co Ltd view
CXSS2200046 拓培非格司亭注射液 telpegfilgrastim Injection Biological Products(1) New Drug Application 2022-04-29 Xiamen Amoytop Biotech Co Ltd view
CXSS2400005 怡培生长激素注射液 Injection Biological Products(1) New Drug Application 2024-01-11 Xiamen Amoytop Biotech Co Ltd view
CXSS2400024 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products(2.2) New Drug Application 2024-03-16 Xiamen Amoytop Biotech Co Ltd view
CXSS2200047 拓培非格司亭注射液 telpegfilgrastim Injection Biological Products(1) New Drug Application 2022-04-29 Xiamen Amoytop Biotech Co Ltd view
CXSS2400004 怡培生长激素注射液 Injection Biological Products(1) New Drug Application 2024-01-11 Xiamen Amoytop Biotech Co Ltd view
CXSS2400025 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products(2.2) New Drug Application 2024-03-16 Xiamen Amoytop Biotech Co Ltd view
CXHL2200828 AK0706片 AK-0706 Tablet Chemical Drugs(1) New Drug Application 2022-10-25 Xiamen Amoytop Biotech Co Ltd view
CXSL2400728 拓培非格司亭注射液 telpegfilgrastim Injection Biological Products(2.2) New Drug Application 2024-10-24 Xiamen Amoytop Biotech Co Ltd view
CXHL2200829 AK0706片 AK-0706 Tablet Chemical Drugs(1) New Drug Application 2022-10-25 Xiamen Amoytop Biotech Co Ltd view
CXSS2400008 怡培生长激素注射液 Injection Biological Products(1) New Drug Application 2024-01-11 Xiamen Amoytop Biotech Co Ltd view
CXSL2400270 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products(2.2) New Drug Application 2024-04-29 Xiamen Amoytop Biotech Co Ltd view
CXSS2200048 拓培非格司亭注射液 telpegfilgrastim Injection Biological Products(1) New Drug Application 2022-04-29 Xiamen Amoytop Biotech Co Ltd view
CXSS2400007 怡培生长激素注射液 Injection Biological Products(1) New Drug Application 2024-01-11 Xiamen Amoytop Biotech Co Ltd view
CXSS2400026 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products(2.2) New Drug Application 2024-03-16 Xiamen Amoytop Biotech Co Ltd view
Y0400712 注射用重组人粒细胞巨噬细胞集落刺激因子 Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Lyophilized Biological Products Supplementary Application 2004-02-09 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2004-06-23 view
Y0400713 注射用重组人粒细胞巨噬细胞集落刺激因子 Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Lyophilized Biological Products Supplementary Application 2004-02-09 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2004-06-23 view
Y0400700 注射用重组人粒细胞巨噬细胞集落刺激因子 Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Lyophilized Biological Products Supplementary Application 2004-02-09 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2004-07-19 view