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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
A19990004 注射用重组人生长激素 Somatropin Lyophilized Chemical Drugs Import Drug Application 2000-01-01 杰希药业有限公司 Hebei Jiexi Biological Products Co Ltd Pending Review 1999-03-12 view
AS19990013 重组人生长激素 Somatropin Lyophilized Biological Products Import Drug Application 2000-01-01 Instituto Sidus SA view
AS20000005 重组人生长激素注射液 Somatropin Injection Biological Products Import Drug Application 2000-01-01 诺和诺德(天津)生物技术有限公司 Novo Nordisk (China) Pharmaceuticals Co Ltd Approval Completed-Pending Certificated view
AS20010006 生长激素 Somatropin Lyophilized Biological Products New Drug Application 2001-08-02 雪兰诺新加坡私人有限公司北京办事处 Approval Completed-Pending Certificated 2003-01-29 view
AS20010015 重组人生长激素 Somatropin Lyophilized Biological Products New Drug Application 2003-08-13 韩国希诺有限公司北京代表处 Shino Co Ltd Beijing Representative Office Approval Completed-Pending Certificated 2003-11-17 view
CSb01003 注射用重组人生长激素 Somatropin Lyophilized Biological Products(2) Supplementary Application 2001-02-08 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2001-06-22 view
CSb20020097 注射用重组人生长激素 Somatropin Lyophilized Biological Products(2) Supplementary Application 2002-07-30 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2003-07-21 view
CSb20020098 注射用重组人生长激素 Somatropin Lyophilized Biological Products(2) Supplementary Application 2002-07-30 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-07-03 view
CSb20020099 注射用重组人生长激素 Somatropin Lyophilized Biological Products(2) Supplementary Application 2002-07-30 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-07-03 view
CSb20020100 注射用重组人生长激素 Somatropin Lyophilized Biological Products(2) Supplementary Application 2002-07-30 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-07-03 view
CSL00053 注射用重组人生长激素 Somatropin Lyophilized Biological Products(5) New Drug Application 2000-10-24 安微安科生物高技术有限责任公司 Anhui Anke Biotechnology (Group) Co Ltd Pending Approval 2001-09-19 view
CSL20020023 注射用重组人生长激素 Somatropin Lyophilized Biological Products(5) New Drug Application 2002-05-20 盈智国际(香港)有限公司北京代表处 Yingzhi International (Hong Kong) Limited Beijing Representative Office Approval Completed-Pending Certificated 2003-01-23 view
CXSB0600030 重组人生长激素注射液 Somatropin Injection Biological Products Supplementary Application 2006-09-13 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2007-06-12 view
CXSB0600134 重组人生长激素注射液 Somatropin Injection Biological Products Supplementary Application 2007-04-26 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2008-08-22 view
CXSB0700037 聚乙二醇重组人生长激素注射液 Polyethylene Glycol Recombinant Human Growth Hormone Injection Biological Products Supplementary Application 2007-05-15 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2008-02-22 view
CXSB0700112 注射用重组人生长激素 Somatropin Lyophilized Biological Products Supplementary Application 2008-11-03 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2009-12-15 view
CXSB0700113 注射用重组人生长激素 Somatropin Lyophilized Biological Products Supplementary Application 2008-11-03 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2009-12-15 view
CXSB0700116 重组人生长激素注射液 Somatropin Injection Biological Products Supplementary Application 2008-11-03 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2009-12-15 view
CXSB1200005 聚乙二醇化重组人生长激素注射液 Polyethylene Glycol Recombinant Human Growth Hormone Injection Biological Products Supplementary Application 2012-03-23 安徽安科生物工程(集团)股份有限公司 Anhui Anke Biotechnology (Group) Co Ltd Certificate Issued 2014-07-02 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