Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | 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 |
CXSL1900007 | 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 | 2019-01-29 | 百奥泰生物科技(广州)有限公司 | Bio-Thera Solutions Ltd | In Review | 2019-01-28 | view |