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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
BS20000004 重组人粒细胞集落刺激因子 Granulocyte colony-stimulating factor receptor Injection Biological Products Import Drug Application 2000-01-01 麒麟鲲鹏(中国)生物有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-02-21 view
BS20000006 重组人类红细胞生成素 Lyophilized Biological Products Import Drug Application 2000-01-01 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 2002-04-15 view
BS20000005 重组人红细胞生成素 Lyophilized Biological Products Import Drug Application 2000-01-01 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 2001-01-12 view
CSS00078 重组人粒细胞集落刺激因子 Granulocyte colony-stimulating factor receptor Injection Biological Products(4) New Drug Application 2000-10-18 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Pending Approval 2001-06-22 view
CSS00077 重组人粒细胞集落刺激因子 Granulocyte colony-stimulating factor receptor Injection Biological Products(4) New Drug Application 2000-10-18 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 2001-07-20 view
CSS00076 重组人红细胞生成素 Lyophilized Biological Products(4) New Drug Application 2000-10-18 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2001-10-11 view
CSS00075 重组人红细胞生成素 Lyophilized Biological Products(4) New Drug Application 2000-10-18 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2001-10-11 view
CSS00079 重组人粒细胞集落刺激因子 Granulocyte colony-stimulating factor receptor Injection Biological Products(4) New Drug Application 2000-10-18 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Pending Approval 2001-06-22 view
BS20000010 重组人粒细胞集落刺激因子 Granulocyte colony-stimulating factor receptor Injection Biological Products Import Drug Application 2001-02-26 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 view
A20020004 白消安 busulfan Active ingredient Chemical Drugs New Drug Application 2002-02-08 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 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
HS20020026 重组人红细胞生成素 Lyophilized Biological Products Import Drug Application 2002-08-07 麒麟(中国)医药有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
HS20020027 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products Import Drug Application 2002-08-07 麒麟(中国)医药有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Approval Completed-Pending Certificated 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
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
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
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
CYSB0600083 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2007-03-23 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2007-10-26 view
JYHB1100579 盐酸奥洛他定片 olopatadine hydrochloride Tablet Chemical Drugs Supplementary Application 2011-07-04 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2011-11-10 view