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 |