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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CSL01051 病毒灭活人全血清 Other Biological Products(4) New Drug Application 2001-12-14 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Approval Completed-Pending Certificated 2003-02-09 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
CSL20020078 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(4) New Drug Application 2002-11-13 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2003-11-28 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 Certificate Issued 2009-05-15 view
CXSL0500010 ACW135Y群脑膜炎球菌多糖疫苗 Group ACYW135 Meningococcal Polysaccharide Vaccine Lyophilized Biological Products(6) New Drug Application 2005-02-22 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2006-04-28 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
CXSL0600037 大流行流感裂解疫苗 Injection Biological Products(1) New Drug Application 2006-08-02 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2007-06-12 view
CXSL0600063 外用冻干人凝血酶 thrombin alfa Other Biological Products(14) New Drug Application 2007-03-27 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2008-05-07 view
CXSL1900155 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
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
CXSL1900157 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
CXSL2000160 HL08 HL08 Injection Biological Products(1) New Drug Application 2020-07-04 华兰生物工程股份有限公司 Hualan Biological Engineering Inc In Review 2020-07-02 view
CXSL2300595 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2023-09-02 Hualan Biological Engineering Inc 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 Certificate Issued 2007-01-11 view
CYSB0500078 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products Supplementary Application 2005-06-19 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2007-12-26 view
CYSB0600032 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2006-09-06 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2008-01-03 view
CYSB0900251 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
CYSB0900252 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
CYSB0900253 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 2011-10-20 view