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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXZS0506915 七叶神安软胶囊 Soft capsules Chinese Herbal Medicine(8) New Drug Application 2006-02-07 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2009-04-16 view
CXHL1501124 乙磺酸尼达尼布 nintedanib esylate Active ingredient Chemical Drugs(3.1) New Drug Application 2015-06-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
CXHL1501125 乙磺酸尼达尼布软胶囊 nintedanib esylate Soft capsules Chemical Drugs(3.1) New Drug Application 2015-06-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
CXHL1501126 乙磺酸尼达尼布软胶囊 nintedanib esylate Soft capsules Chemical Drugs(3.1) New Drug Application 2015-06-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
X0401883 仙灵强骨口服液 Oral solution Chinese Herbal Medicine(6) New Drug Application 2005-01-07 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2005-06-17 view
CYHS0509564 伏格列波糖 voglibose Active ingredient Chemical Drugs(6) Generic Drug 2006-02-07 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2007-05-15 view
CXHL0502519 伏格列波糖分散片 voglibose Tablet Chemical Drugs(5) New Drug Application 2006-02-07 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2007-06-11 view
CXHL0502520 伏格列波糖口腔崩解片 voglibose Tablet Chemical Drugs(5) New Drug Application 2006-02-07 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2008-11-28 view
X0304382 依达拉奉 edaravone Active ingredient Chemical Drugs(2) New Drug Application 2003-08-22 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2004-01-19 view
CXL01F76 依达拉奉 edaravone Active ingredient Chemical Drugs(2) New Drug Application 2001-12-07 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
CXL01F77 依达拉奉注射液 edaravone Injection Chemical Drugs(2) New Drug Application 2001-12-07 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd view
CYHS0506468 单硝酸异山梨酯片 isosorbide mononitrate Tablet Chemical Drugs(6) Generic Drug 2005-10-13 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2006-07-04 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
CXHL1401693 卡格列净 canagliflozin Active ingredient Chemical Drugs(3.1) New Drug Application 2014-11-26 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-04-07 view
CXHL1401694 卡格列净片 canagliflozin Tablet Chemical Drugs(3.1) New Drug Application 2014-11-26 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-04-07 view
CYHS0505245 双氯芬酸钠凝胶 diclofenac sodium Gel Chemical Drugs(6) Generic Drug 2005-07-27 海南先声药业有限公司 Hainan Simcere Pharmaceutical Co Ltd Certificate Issued 2005-12-19 view
FX20020482 双氯芬酸钠缓释胶囊 diclofenac sodium Capsules, extended release Chemical Drugs Generic Drug 2002-08-07 海南海富制药有限公司 Hainan Simcere Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-12-16 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