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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
CXSL1500080 重组全人源抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-10-19 上海华奥泰生物药业有限公司 Shanghai Huaota Biopharmaceutical Co Ltd Certificate Issued 2016-12-30 view
CXSL1700057 重组全人源抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-07-20 上海华奥泰生物药业有限公司 Shanghai Huaota Biopharmaceutical Co Ltd Certificate Issued 2018-06-28 view
CXSL1600095 重组抗TNFα全人单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-12-12 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2017-04-20 view
CXSL1300056 重组抗TNFα全人单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2013-12-23 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-01-14 view
CXSL1700013 重组抗肿瘤坏死因子α全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-04-24 上海谐生医药科技有限公司 Shanghai Xiesheng Medical Technology Co Ltd Certificate Issued 2018-03-20 view
CXSL1400118 重组抗TNFα全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-03-24 上海迈泰亚博生物技术有限公司 Shanghai MabLab Biotechnology Co Ltd Certificate Issued 2016-09-03 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
CXSL1500023 重组抗肿瘤坏死因子-α全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-05-08 北京东方百泰生物科技有限公司 Beijing Dongfang Biotech Co Ltd Certificate Issued 2017-02-13 view
CXSL1700017 重组全人源抗TNF-α单抗注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-09-14 北京双鹭药业股份有限公司 Beijing SL Pharmaceutical Co Ltd Certificate Issued 2018-09-03 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
CXSL1500032 重组人源抗人肿瘤坏死因子(TNF-α)单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-05-13 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2017-02-13 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
CXSL1300035 重组抗肿瘤坏死因子-α全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2013-07-22 嘉和生物药业有限公司 Genor Biopharma Co Ltd Certificate Issued 2016-03-28 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