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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
X0300087 重组人生长激素注射液 Somatropin Injection Biological Products(13) New Drug Application 2003-01-17 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2003-07-21 view
X0300088 重组人生长激素注射液 Somatropin Injection Biological Products(13) New Drug Application 2003-01-17 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2003-07-30 view
X0402441 长效重组人生长激素注射液 Injection Biological Products(9) New Drug Application 2004-05-12 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2005-08-25 view
Y0413772 重组人生长激素注射液 Somatropin Injection Biological Products(15) Generic Drug 2004-11-12 上海联合赛尔生物工程有限公司 Shanghai United Cell Biotechnology Co Ltd Certificate Issued 2005-06-23 view
Y0413771 重组人生长激素注射液 Somatropin Injection Biological Products(15) Generic Drug 2004-11-12 上海联合赛尔生物工程有限公司 Shanghai United Cell Biotechnology Co Ltd Certificate Issued 2005-06-23 view
X0402134 重组人生长激素注射液 Somatropin Injection Biological Products(13) New Drug Application 2004-12-15 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2005-03-04 view
X0402135 重组人生长激素注射液 Somatropin Injection Biological Products(13) New Drug Application 2004-12-15 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2005-03-04 view
JXSL0500029 重组人生长激素注射液 Somatropin Injection Biological Products(7) Import Drug Application 2005-12-30 Ipsen Ltd Certificate Issued 2007-03-28 view
CXSL0600013 重组人生长激素注射液 Somatropin Injection Biological Products(13) New Drug Application 2006-04-10 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2006-12-30 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
JXSL0700018 重组人生长激素注射液 Somatropin Injection Biological Products(7) Import Drug Application 2007-05-14 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2008-09-03 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
CXSL0700027 聚乙二醇化重组人生长激素注射液 Polyethylene Glycol Recombinant Human Growth Hormone Injection Biological Products(9) New Drug Application 2007-11-06 安徽安科生物工程(集团)股份有限公司 Anhui Anke Biotechnology (Group) Co Ltd Certificate Issued 2011-09-29 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
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
CXSS0800026 聚乙二醇重组人生长激素注射液 Polyethylene Glycol Recombinant Human Growth Hormone Injection Biological Products(9) New Drug Application 2008-12-08 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2009-07-21 view
CXSS0800028 聚乙二醇重组人生长激素注射液 Polyethylene Glycol Recombinant Human Growth Hormone Injection Biological Products(9) New Drug Application 2008-12-08 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2014-01-16 view
CXSS0800027 聚乙二醇重组人生长激素注射液 Polyethylene Glycol Recombinant Human Growth Hormone Injection Biological Products(9) New Drug Application 2008-12-08 长春金赛药业有限责任公司 Changchun GeneScience Pharmaceutical Co Ltd Certificate Issued 2009-07-21 view