Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXSL1700058 | 注射用重组抗HER2人源化单抗-DM1偶联物 | recombinant humanized anti-HER2 mAb-DM1 | Lyophilized | Biological Products(2) | New Drug Application | 2017-08-24 | 三生国健药业(上海)股份有限公司 | Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd | In Review | 2017-08-22 | view |
CXSL1600103 | 注射用重组抗HER2人源化单克隆抗体-DM1 | recombinant humanized anti-HER2 mAb-DM1 | Lyophilized | Biological Products(1) | New Drug Application | 2017-01-05 | 齐鲁制药有限公司 | QILU Pharmaceutical Co Ltd | Certificate Issued | 2017-09-27 | view |