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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB0500112 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Supplementary Application 2005-11-20 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2006-05-29 view
X0402658 达依泊汀α注射液 darbepoetin alfa Injection Biological Products(7) New Drug Application 2004-05-24 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
X0402659 达依泊汀α注射液 darbepoetin alfa Injection Biological Products(7) New Drug Application 2004-05-24 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
CSb20020146 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products(4) Supplementary Application 2002-10-29 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2002-12-27 view
CSb20020145 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products(4) Supplementary Application 2002-10-29 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2002-12-27 view
CSB20020026 重组人粒细胞集落刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2002-04-01 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-07-09 view