Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXHL1600343 | ZL-2306对甲苯磺酸盐一水合物 | niraparib tosylate | Active ingredient | Chemical Drugs(1) | New Drug Application | 2017-03-01 | 上海合全药业股份有限公司 | Shanghai Syntheall Pharmaceutical Co Ltd | Certificate Issued | 2017-07-24 | view |
CXHB1700125 | ZL-2306对甲苯磺酸盐一水合物 | niraparib tosylate | Active ingredient | Chemical Drugs | Supplementary Application | 2018-01-12 | 上海合全药业股份有限公司 | Shanghai Syntheall Pharmaceutical Co Ltd | In Review | 2018-01-11 | view |