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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
FS20020003 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Generic Drug 2002-03-12 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Approval Completed-Pending Certificated 2002-07-25 view
FS20020002 人破伤风免疫球蛋白 Injection Biological Products Generic Drug 2002-03-12 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Approval Completed-Pending Certificated 2002-10-29 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
Y0400082 静脉注射用人免疫球蛋白(pH4) human immunoglobulin(PH4) 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
Y0400081 静脉注射用人免疫球蛋白(pH4) human immunoglobulin(PH4) 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
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
Y0400077 人免疫球蛋白 human 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
Y0400079 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
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
Y0400078 人免疫球蛋白 human 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
Y0400083 静脉注射用人免疫球蛋白(pH4) human immunoglobulin(PH4) 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
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
X0404708 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
X0404707 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
Y0414203 人免疫球蛋白 human 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
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
Y0414201 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