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