Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXHL1600344 | ZL-2306胶囊 | niraparib tosylate | Capsule | Chemical Drugs(1) | New Drug Application | 2017-03-01 | 再鼎医药(上海)有限公司 | Zai Lab (Shanghai) Co Ltd | Certificate Issued | 2017-07-24 | view |
CXHB1900068 | ZL-2306胶囊 | niraparib tosylate | Capsule | Chemical Drugs | Supplementary Application | 2019-11-15 | 再鼎医药(上海)有限公司 | Zai Lab (Shanghai) Co Ltd | In Review | 2019-11-14 | view |