Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXHS1800043 | 对甲苯磺酸尼拉帕利胶囊 | niraparib tosylate | Capsule | Chemical Drugs(1) | New Drug Application | 2018-12-17 | 再鼎医药(苏州)有限公司 | Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd | Certificate Issued | 2019-12-30 | view |
CYHB2008144 | 甲苯磺酸尼拉帕利胶囊 | niraparib tosylate | Capsule | Chemical Drugs(1) | Supplementary Application | 2020-10-27 | 再鼎医药(上海)有限公司,再鼎医药(苏州)有限公司 | Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd | Certificate Issued | 2021-10-25 | view |
CXHS2000009 | 甲苯磺酸尼拉帕利胶囊 | niraparib tosylate | Capsule | Chemical Drugs(2.4) | New Drug Application | 2020-03-20 | 再鼎医药(苏州)有限公司 | Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd | Certificate Issued | 2020-09-16 | view |