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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 Certificate Issued 2019-12-30 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 Certificate Issued 2020-09-16 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 Certificate Issued 2021-10-25 view
CYHB2008100 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(2.4) Supplementary Application 2020-10-26 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-10-23 view
CXHB2000126 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) Supplementary Application 2020-11-20 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-11-19 view
CXHB2000125 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) Supplementary Application 2020-11-20 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2020-11-19 view
CXHL1900377 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) New Drug Application 2019-11-29 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-28 view
CXHL1900376 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) New Drug Application 2019-11-29 再鼎医药(上海)有限公司 Zai Lab (Shanghai) Co Ltd In Review 2019-11-28 view
CYHB2200630 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs Supplementary Application 2022-04-19 view
CYHB2400347 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs Supplementary Application 2024-03-07 view
CYHB2102282 甲苯磺酸尼拉帕利胶囊 niraparib tosylate Capsule Chemical Drugs(1) Supplementary Application 2021-12-10 view