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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB2000366 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-09-02 view
CYSB2000364 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-27 view
CYSB2100039 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2021-01-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-19 view
CYSB2100038 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2021-01-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-19 view
CYSB2000369 冻干静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Lyophilized Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-06 view
CXSS1900045 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products(15) New Drug Application 2019-12-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-04 view
CXSS2000037 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2020-07-04 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-07-13 view
CYSB1900431 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2020-01-03 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-01-08 view
CYSB1900432 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2020-01-03 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-01-08 view
CYSB2000365 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 view
CYSB2000363 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 view
CYSB2000368 冻干静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Lyophilized Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 view
CYSB2000367 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 view
CYSB1800194 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products Supplementary Application 2018-09-28 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2020-10-21 view
CYSB1800221 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2018-10-25 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2019-09-30 view
CYSB1700015 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2017-09-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2019-08-13 view
CYSB1700014 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2017-09-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2019-08-13 view
CYSB1800008 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products Supplementary Application 2018-01-29 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2018-05-24 view
CYSB1600083 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2016-06-29 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2017-12-11 view
CYSB1600195 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2017-02-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2017-07-06 view