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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS1800016 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2018-08-22 河北大安制药有限公司 Bohui Biopharmaceutical (Hebei) Co Ltd In Approval 2021-12-07 view
CXSB2100004 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products Supplementary Application 2021-01-11 成都蓉生药业有限责任公司 Chengdu Rongsheng Pharmaceuticals Co Ltd Certificate Issued 2021-10-08 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
CYSB2000239 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products Supplementary Application 2020-10-29 四川远大蜀阳药业有限责任公司 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd Certificate Issued 2021-01-15 view
CXSS2000011 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2020-04-01 新疆德源生物工程有限公司 Xinjiang Deyuan Biological Engineering Co Ltd In Review 2020-03-31 view
CXSS2000010 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2020-04-01 新疆德源生物工程有限公司 Xinjiang Deyuan Biological Engineering Co Ltd In Review 2020-03-31 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
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
CYSB1800294 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2019-01-02 深圳市卫光生物制品股份有限公司 Shenzhen Weiguang Biological Products Co Ltd Certificate Issued 2019-06-26 view
CYSB1800293 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2019-01-02 深圳市卫光生物制品股份有限公司 Shenzhen Weiguang Biological Products Co Ltd Certificate Issued 2019-06-26 view
CYSB1800292 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2019-01-02 深圳市卫光生物制品股份有限公司 Shenzhen Weiguang Biological Products Co Ltd Certificate Issued 2019-06-26 view
CXSS1700002 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2017-03-21 山西康宝生物制品股份有限公司 Shanxi Kangbao Biological Product Co Ltd Certificate Issued 2019-03-19 view
CXSS1700001 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2017-03-21 山西康宝生物制品股份有限公司 Shanxi Kangbao Biological Product Co Ltd Certificate Issued 2019-03-19 view
CXSS1700003 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2017-03-21 山西康宝生物制品股份有限公司 Shanxi Kangbao Biological Product Co Ltd Certificate Issued 2019-03-19 view
CXSL1700139 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2018-01-08 华兰生物工程重庆有限公司 Hualan Biological Engineering Chongqing Co Ltd Certificate Issued 2018-09-25 view
CXSL1700138 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2018-01-08 华兰生物工程重庆有限公司 Hualan Biological Engineering Chongqing Co Ltd In Review 2018-01-04 view
CXSS1400009 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2014-05-19 贵州中泰生物科技有限公司 China National Pharmaceutical Group Guizhou Biopharmaceutical Co Ltd Certificate Issued 2017-08-04 view
CXSS1400010 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2014-05-19 贵州中泰生物科技有限公司 China National Pharmaceutical Group Guizhou Biopharmaceutical Co Ltd Certificate Issued 2017-08-04 view
CXSS1500001 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2015-10-28 上海莱士血液制品股份有限公司 Shanghai RAAS Blood Products Co Ltd Certificate Issued 2016-12-08 view
CXSS1300025 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2014-01-13 山东泰邦生物制品有限公司 Shandong Taibang Biological Products Co Ltd Certificate Issued 2016-03-10 view