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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1200035 人源化抗人TNFα单克隆抗体注射液(CHO细胞) adalimumab Injection Biological Products(1) New Drug Application 2012-07-20 沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Co Ltd Certificate Issued 2014-11-21 view
CXSB2200096 人源化抗人TNFα单克隆抗体注射液(CHO细胞) adalimumab Injection Biological Products(1) Supplementary Application 2022-11-08 Shenyang Sunshine Pharmaceutical Co Ltd view
CXSB2101002 人源化抗人TNFα单克隆抗体注射液(CHO细胞) adalimumab Injection Biological Products(1) Supplementary Application 2021-03-18 Shenyang Sunshine Pharmaceutical Co Ltd view
CXSL1400074 全人源抗人TNF-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2014-09-28 武汉生物制品研究所有限责任公司 Wuhan Institute of Biological Products Co Ltd Certificate Issued 2015-09-23 view
CXSL1600065 抗TNFα全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-09-02 大庆东竺明生物技术有限公司 DZM Biotech Ltd Certificate Issued 2017-05-22 view
CXSL1600064 抗人肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-11-10 北京绿竹生物技术股份有限公司 Beijing Lvzhu Biological Technology Co Ltd Certificate Issued 2017-11-21 view
CXSL1400098 抗人肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-01-19 北京绿竹生物技术股份有限公司 Beijing Lvzhu Biological Technology Co Ltd Certificate Issued 2016-05-12 view
CXSB1600010 注射用重组人源化抗人肿瘤坏死因子α单克隆抗体 adalimumab Injection Biological Products Supplementary Application 2016-09-05 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-11-17 view
CXSB1600009 注射用重组人源化抗人肿瘤坏死因子α单克隆抗体 adalimumab Injection Biological Products Supplementary Application 2016-09-05 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-11-17 view
CXSL1200030 注射用重组人源化抗肿瘤坏死因子α单克隆抗体 adalimumab Injection Biological Products(1) New Drug Application 2012-06-19 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2014-03-04 view
J0300782 肿瘤坏死因子α单克隆抗体注射剂 adalimumab Injection Biological Products(7) Import Drug Application 2004-06-09 Abbott Laboratories Ltd Abbott Laboratories Ltd Certificate Issued 2004-12-27 view
JYSB0700067 肿瘤坏死因子α单克隆抗体注射剂 adalimumab Injection Biological Products Supplementary Application 2007-05-11 瑞士雅培制药有限公司北京办事处 Abbott Laboratories SA-Beijing Representative Office Certificate Issued 2007-09-18 view
CXSL1300050 肿瘤坏死因子α重组全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2013-08-16 吉林康慧生物科技有限公司 Alphamab Jilin Co Ltd Certificate Issued 2016-01-14 view
CXSL1600059 重组人TNFα单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-09-12 海南赛乐敏生物科技有限公司 Hainan Sailemin Biotechnology Co Ltd Certificate Issued 2017-12-21 view
CXSL1300033 重组人抗TNF-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2013-05-28 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2016-01-14 view
CXSL1700003 重组人抗TNF-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-01-19 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2017-09-14 view
CXSL1400002 重组人抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2014-02-17 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-01-13 view
CXSB1700005 重组人抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products Supplementary Application 2017-08-18 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-01-17 view
CXSL1400005 重组人抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2014-02-19 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-01-13 view
CXSL1600012 重组人源化抗肿瘤坏死因子α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-05-03 深圳万乐药业有限公司 Shenzhen Main Luck Pharmaceuticals INC Certificate Issued 2017-07-06 view