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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CYSB1200152 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2012-06-19 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2013-05-31 view
CXSL0500012 注射用重组人生长激素 somatropin Lyophilized Biological Products(10) New Drug Application 2005-02-22 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd In Approval 2007-03-19 view
CXSS1300028 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products(1) New Drug Application 2014-01-17 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd;Xiamen Bosai Gene Transcription Technology Co Ltd Certificate Issued 2016-09-09 view
CXSL0700039 Y型PEG化重组人粒细胞刺激因子注射液 Injection Biological Products(1) New Drug Application 2008-02-26 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2010-03-11 view
CXSB1900011 Y型PEG化重组人促红素注射液 Injection Biological Products Supplementary Application 2019-06-05 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd;Xiamen Bosai Gene Transcription Technology Co Ltd In Review 2019-06-04 view
CYSB1200141 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2012-06-19 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2013-05-31 view
X0403171 注射用重组人白细胞介素-11 recombinant human interleukin-11 Lyophilized Biological Products(2) New Drug Application 2004-11-24 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2005-04-19 view
CYSB1200120 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2012-09-24 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2013-09-13 view
CXSL0500060 重组人干扰素α2a注射液 recombinant human interferon α2a Injection Biological Products(10) New Drug Application 2005-07-18 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2007-06-12 view
CYSB1600227 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products Supplementary Application 2017-04-18 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2017-09-27 view
CXSB1100008 Y型PEG化重组人干扰素α2b注射液 peginterferon alfa-2b Injection Biological Products Supplementary Application 2011-06-08 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2012-03-13 view
X0403167 注射用重组人白细胞介素-11 recombinant human interleukin-11 Lyophilized Biological Products(2) New Drug Application 2004-11-25 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2005-04-19 view
CXSB1300010 注射用重组人生长激素 somatropin Lyophilized Biological Products Supplementary Application 2013-05-02 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd;Xiamen Bosai Gene Transcription Technology Co Ltd Certificate Issued 2014-10-31 view
CXSL0700028 Y型PEG化重组人干扰素α2a注射液 peginterferon alfa-2a Injection Biological Products(1) New Drug Application 2007-10-25 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2010-11-23 view
CXSB1900005 Y型PEG化重组人粒细胞刺激因子注射液 Injection Biological Products Supplementary Application 2019-03-13 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd;Xiamen Bosai Gene Transcription Technology Co Ltd In Review 2019-03-12 view
CXSL1100077 重组人白介素-11注射液 recombinant human interleukin-11 Injection Biological Products(13) New Drug Application 2012-01-11 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2013-01-30 view
X0403170 注射用重组人白细胞介素-11 recombinant human interleukin-11 Lyophilized Biological Products(2) New Drug Application 2004-11-24 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2005-04-19 view
CYSB1200119 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2012-09-24 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2013-09-13 view
CXSL0500063 重组人干扰素α2b注射液 Recombinant Human Interferon α2b Injection Biological Products(10) New Drug Application 2005-07-10 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2006-12-30 view