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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB2400305 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2024-11-21 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2400267 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2024-10-10 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2300149 静注人免疫球蛋白(10%) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2023-08-02 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CXSL2300529 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2023-08-01 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CXSS2300008 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(3.4) New Drug Application 2023-03-08 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CXSS2200022 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(3.4) New Drug Application 2022-03-08 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2000332 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) Supplementary Application 2020-12-09 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd In Review 2020-12-08 view
CYSB2000333 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) Supplementary Application 2020-12-09 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2021-08-27 view
CXSS1800012 人凝血因子VIII Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2018-06-11 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2020-06-22 view
CXSL1800056 外用人凝血酶 thrombin alfa Other Biological Products(15) New Drug Application 2018-05-21 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd In Review 2018-05-18 view
CXSL1700197 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2018-03-09 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2018-06-28 view
CXSL1700182 人纤维蛋白粘合剂 Human Fibrin Sealant Kit Liniment Biological Products(15) New Drug Application 2018-03-09 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd In Review 2018-03-07 view
CXSL1600126 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(15) New Drug Application 2017-05-04 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2018-03-20 view
CXZL1500027 复方山芪颗粒 Granule Chinese Herbal Medicine(6.1) New Drug Application 2015-07-30 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2017-03-29 view
CXSL1400070 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2014-11-17 广东双林生物制药有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2015-10-28 view
Y0416523 静脉注射用人免疫球蛋白(pH4.0) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2004-12-30 三九集团湛江开发区双林药业有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2005-07-13 view
Y0416404 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2004-12-27 三九集团湛江开发区双林药业有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2006-12-30 view
Y0411775 人狂犬病免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) Generic Drug 2004-10-18 三九集团湛江开发区双林药业有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2006-03-24 view
Y0411773 人破伤风免疫球蛋白 Injection Biological Products(15) Generic Drug 2004-10-18 三九集团湛江开发区双林药业有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2006-03-08 view
Y0411780 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) Generic Drug 2004-10-18 三九集团湛江开发区双林药业有限公司 Guangdong Shuanglin Bio-Pharmacy Co Ltd Certificate Issued 2006-05-15 view