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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2200828 AK0706片 AK-0706 Tablet Chemical Drugs(1) New Drug Application 2022-10-25 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
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
CXSB1100015 Y型PEG化重组人干扰素α2b注射液 peginterferon alfa-2b Injection Biological Products Supplementary Application 2011-10-08 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2012-10-30 view
CXSB1100016 Y型PEG化重组人干扰素α2a注射液 Peginterferon alfa-2a Injection Biological Products Supplementary Application 2011-11-17 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2012-12-25 view
CXSB1200013 Y型PEG化重组人粒细胞刺激因子注射液 Injection Biological Products Supplementary Application 2012-08-01 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
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 Certificate Issued 2014-10-31 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 In Review 2019-03-12 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 In Review 2019-06-04 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
CXSL0500013 重组人白细胞介素-2注射液 Recombinant Human Interleukin-2 Injection 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 Certificate Completed-Pending Issued 2007-05-08 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
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
CXSL0700020 Y型PEG化重组人干扰素α2b注射液 peginterferon alfa-2b Injection Biological Products(1) New Drug Application 2007-09-10 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2009-04-29 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
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
CXSL0800002 Y型PEG化重组人生长激素注射液 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 2010-05-13 view
CXSL0900006 Y型PEG化重组人促红素注射液 Injection Biological Products(1) New Drug Application 2009-05-15 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd Certificate Issued 2011-12-13 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
CXSL1900018 聚乙二醇干扰素α-2b注射液 peginterferon alfa-2b Injection Biological Products(1) New Drug Application 2019-03-05 厦门特宝生物工程股份有限公司 Xiamen Amoytop Biotech Co Ltd In Review 2019-03-04 view