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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB1100015 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products Supplementary Application 2011-02-21 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2012-02-14 view
CYSL0600013 吸附无细胞百白破联合疫苗 Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine,Adsorbed Injection Biological Products(15) Generic Drug 2007-03-19 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2009-06-17 view
Y0414202 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2004-11-12 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2006-03-24 view
CSL01030 冻干人凝血酶 thrombin alfa Other Biological Products(4) New Drug Application 2001-09-26 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Approval Completed-Pending Certificated 2002-07-09 view
CXSL1900156 静注人免疫球蛋白 human immunoglobulin(PH4) Injection Biological Products(7) New Drug Application 2020-01-20 华兰生物工程股份有限公司 Hualan Biological Engineering Inc In Review 2020-01-19 view
CYSB0900255 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2009-10-10 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2017-03-15 view
CYSS0500036 人狂犬病免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) Generic Drug 2005-05-17 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2005-09-23 view
Y0400080 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2004-06-09 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2004-08-16 view
CYSB2100005 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2021-01-06 华兰生物工程股份有限公司 Hualan Biological Engineering Inc In Review 2021-01-05 view
CYSB1000150 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2010-07-14 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2011-03-25 view
CXSS0500155 重组乙型肝炎疫苗(酵母) Recombinant Hepatitis B Vaccine(Saccharomyces cerevisiae) Injection Biological Products(9) New Drug Application 2005-12-28 华兰生物工程股份有限公司 Hualan Biological Engineering Inc;Dalian Kunyang Technology Development Co Ltd Certificate Issued 2007-01-11 view
X0404709 冻干人凝血酶 thrombin alfa Other Biological Products New Drug Application 2004-08-23 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2005-11-07 view
CYSB1700097 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products Supplementary Application 2017-06-15 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2018-04-10 view
CXSB0800032 大流行流感裂解疫苗 Injection Biological Products Supplementary Application 2008-04-23 华兰生物工程股份有限公司 Hualan Biological Engineering Inc;Institute of Microbiology and Epidemiology Academy of Military Medical Sciences PLA Certificate Issued 2009-05-15 view
Y0414198 静脉注射用人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2004-11-12 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2006-03-24 view
CSL20020032 病毒灭活冻干人血浆 Other Biological Products(4) New Drug Application 2002-05-30 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2003-05-09 view
CYSB2000227 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(原15) Supplementary Application 2020-10-15 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2020-11-09 view
CYSB1000152 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products Supplementary Application 2010-07-14 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2011-02-12 view
CXSL0500090 A、C群脑膜炎球菌结合疫苗 Group A plus Group C Meningococcal Conjugate Vaccine Injection Biological Products(7) New Drug Application 2005-11-15 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2006-12-30 view
Y0400084 人破伤风免疫球蛋白 Injection Biological Products Supplementary Application 2004-06-09 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2004-08-16 view