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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHB2400165 注射用盐酸曲拉西利 trilaciclib hydrochloride Lyophilized Chemical Drugs Supplementary Application 2024-01-27 Hainan Simcere Pharmaceutical Co Ltd view
CYHB2301624 阿莫西林胶囊 amoxicillin Capsule Chemical Drugs Supplementary Application 2023-07-17 Hainan Simcere Pharmaceutical Co Ltd view
CYHB2350123 苯磺酸左氨氯地平片 levamlodipine besylate Tablet Chemical Drugs Supplementary Application 2023-02-02 Hainan Simcere Pharmaceutical Co Ltd view
CYHB2300123 注射用盐酸曲拉西利 trilaciclib hydrochloride Lyophilized Chemical Drugs(5.1) Supplementary Application 2023-01-14 Hainan Simcere Pharmaceutical Co Ltd view
CXHB2200133 注射用SIM1910-09 AER-271 Lyophilized Chemical Drugs(1) Supplementary Application 2022-08-17 Hainan Simcere Pharmaceutical Co Ltd view
CYHB2200560 氢溴酸右美沙芬颗粒 dextromethorphan hydrobromide Granule Chemical Drugs Supplementary Application 2022-03-30 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2102165 阿普米司特片 apremilast Tablet Chemical Drugs(4) Generic Drug 2021-12-09 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2102167 阿普米司特片 apremilast Tablet Chemical Drugs(4) Generic Drug 2021-12-09 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2102166 阿普米司特片 apremilast Tablet Chemical Drugs(4) Generic Drug 2021-12-09 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2101946 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(4) Generic Drug 2021-11-03 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2101233 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(4) Generic Drug 2021-06-02 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2101235 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(4) Generic Drug 2021-06-02 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2101234 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(4) Generic Drug 2021-06-02 Hainan Simcere Pharmaceutical Co Ltd view
CYHL2101007 巴曲酶注射液 batroxobin Injection Chemical Drugs(3) Generic Drug 2021-05-11 Hainan Simcere Pharmaceutical Co Ltd view
JXHL2100110 注射用Trilaciclib trilaciclib hydrochloride Lyophilized Chemical Drugs(2.4) Import Drug Application 2021-04-01 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2021-03-31 view
CXSB2100015 注射用BD0801 sevacizumab Lyophilized Biological Products(1) Supplementary Application 2021-03-10 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2021-03-09 view
CXHL2100115 甲磺酸仑伐替尼胶囊 Lenvatinib mesylate Capsule Chemical Drugs(2.4) New Drug Application 2021-02-20 先声药业有限公司 Simcere Pharmaceutical Co Ltd In Review 2021-02-19 view
CYHS2100198 泊沙康唑注射液 posaconazole Injection Chemical Drugs(4) Generic Drug 2021-02-11 先声药业有限公司 Simcere Pharmaceutical Co Ltd In Review 2021-02-10 view
JXHL2100040 注射用Trilaciclib trilaciclib hydrochloride Lyophilized Chemical Drugs(1) Import Drug Application 2021-02-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2021-02-03 view
CXHL2100061 注射用SIM1910-09 AER-271 Lyophilized Chemical Drugs(1) New Drug Application 2021-01-28 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2021-01-27 view