Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
JYHB2000581 | 注射用ETX2514SUL | ETX2514SUL | Lyophilized | Chemical Drugs(1) | Supplementary Application | 2020-05-18 | 再鼎医药(上海)有限公司 | Zai Lab (Shanghai) Co Ltd;Lyophilization Services of New England Inc;Entasis Therapeutics Holdings Inc | In Review | 2020-08-07 | view |
JXHL1900112 | 注射用ETX2514SUL | ETX2514SUL | Lyophilized | Chemical Drugs(1) | Import Drug Application | 2019-05-22 | 再鼎医药(上海)有限公司 | Zai Lab (Shanghai) Co Ltd;Entasis Therapeutics Holdings Inc | In Review | 2019-05-21 | view |