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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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