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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
CXHL2000340 艾拉莫德片 iguratimod Tablet Chemical Drugs(2.4) New Drug Application 2020-07-04 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-07-02 view
CXHL2000342 艾拉莫德片 iguratimod Tablet Chemical Drugs(2.4) New Drug Application 2020-07-04 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-07-02 view
CXHL2000341 艾拉莫德片 iguratimod Tablet Chemical Drugs(2.4) New Drug Application 2020-07-04 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-07-02 view
CYHS2000320 阿普斯特片 apremilast Tablet Chemical Drugs(3) Generic Drug 2020-05-15 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-05-14 view
CYHS2000319 阿普斯特片 apremilast Tablet Chemical Drugs(3) Generic Drug 2020-05-15 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-05-14 view
CYHS2000321 阿普斯特片 apremilast Tablet Chemical Drugs(3) Generic Drug 2020-05-15 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-05-14 view
CYHS2000168 硝苯地平控释片 nifedipine Tablet, extended release Chemical Drugs(4) Generic Drug 2020-03-05 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-03-04 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
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
CYHS2000005 碳酸司维拉姆片 sevelamer carbonate Tablet Chemical Drugs(4) Generic Drug 2020-01-10 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd In Review 2020-01-09 view
CYHB1903860 蒙脱石散 diosmectite Powder Chemical Drugs Supplementary Application 2019-07-16 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2020-01-14 view
CYHB1950502 头孢克洛干混悬剂 cefaclor Suspension Chemical Drugs Supplementary Application 2019-07-09 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2020-04-22 view
CYHB1850340 美洛昔康片 meloxicam Tablet Chemical Drugs Supplementary Application 2018-11-19 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2019-09-19 view
CYHS0790080 盐酸伐昔洛韦片 valaciclovir hydrochloride Tablet Chemical Drugs(6) Generic Drug 2007-03-27 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2008-10-28 view
CYHS0690489 单硝酸异山梨酯片 isosorbide mononitrate Tablet Chemical Drugs(6) Generic Drug 2006-10-31 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2009-04-29 view