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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS2000133 阿莫西林克拉维酸钾片 Amoxicillin;Potassium Clavulanate Tablet Chemical Drugs(4) Generic Drug 2020-02-19 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2021-12-21 view
CYHB2050701 注射用硼替佐米 bortezomib Lyophilized Chemical Drugs(原6) Supplementary Application 2020-11-13 先声药业有限公司 Simcere Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2021-11-22 view
CYHB2050702 注射用硼替佐米 bortezomib Lyophilized Chemical Drugs(原6) Supplementary Application 2020-11-13 先声药业有限公司 Simcere Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2021-11-22 view
CYHB2009336 头孢丙烯胶囊 cefprozil Capsule Chemical Drugs(原5) Supplementary Application 2020-11-19 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2021-09-14 view
CYHB2009335 头孢丙烯胶囊 cefprozil Capsule Chemical Drugs(原5) Supplementary Application 2020-11-19 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2021-09-14 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
CYHS2000126 吗替麦考酚酯胶囊 mycophenolate mofetil Capsule Chemical Drugs(4) Generic Drug 2020-02-18 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2021-03-03 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
CYHS2100066 富马酸丙酚替诺福韦片 tenofovir alafenamide fumarate Tablet Chemical Drugs(4) Generic Drug 2021-01-25 先声药业有限公司 Simcere Pharmaceutical Co Ltd In Review 2021-01-25 view
CYHB2150053 阿莫西林克拉维酸钾干混悬剂 Amoxicillin;Potassium Clavulanate Suspension Chemical Drugs Supplementary Application 2021-01-20 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2021-01-19 view
CYHL2100002 注射用伏立康唑 voriconazole Lyophilized Chemical Drugs(4) Generic Drug 2021-01-11 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2021-01-11 view
CXSL2000336 注射用BD0801 sevacizumab Lyophilized Biological Products(1) New Drug Application 2020-12-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2020-12-02 view
CYHB2009867 注射用盐酸苯达莫司汀 bendamustine hydrochloride Lyophilized Chemical Drugs(3) Supplementary Application 2020-11-30 先声药业有限公司 Simcere Pharmaceutical Co Ltd In Review 2020-11-30 view
JXHL2000304 注射用Trilaciclib trilaciclib hydrochloride Lyophilized Chemical Drugs(1) Import Drug Application 2020-11-18 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2020-11-17 view
CXHL2000462 SIM1909-13片 SIM-1909-13 Tablet Chemical Drugs(1) New Drug Application 2020-09-16 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2020-09-16 view
CXHL2000463 SIM1909-13片 SIM-1909-13 Tablet Chemical Drugs(1) New Drug Application 2020-09-16 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2020-09-16 view