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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSL20020079 Bc1-2反义硫代磷酸寡脱氧核苷酸 Other Biological Products(1) New Drug Application 2003-04-18 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2006-10-27 view
CYHS1200139 伊班膦酸钠 ibandronate sodium Active ingredient Chemical Drugs(6) Generic Drug 2012-08-27 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd In Review 2012-08-24 view
CYHS1200143 伊班膦酸钠注射液 ibandronate sodium Injection Chemical Drugs(6) Generic Drug 2012-08-27 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2018-07-06 view
CYHB2250119 伊班膦酸钠注射液 ibandronate sodium Injection Chemical Drugs(原6) Supplementary Application 2022-02-17 Fuzhou Jinshan Biological Pharmaceutical Co Ltd view
CYHB2250120 伊班膦酸钠注射液 ibandronate sodium Injection Chemical Drugs(原6) Supplementary Application 2022-02-17 Fuzhou Jinshan Biological Pharmaceutical Co Ltd view
CYHS1200144 伊班膦酸钠注射液 ibandronate sodium Injection Chemical Drugs(6) Generic Drug 2012-08-27 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2020-04-14 view
Y0303279 依诺沙星软膏 enoxacin Ointment Chemical Drugs(6) Generic Drug 2003-09-12 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2004-04-16 view
CXHS0700012 坎地沙坦酯 candesartan cilexetil Active ingredient Chemical Drugs(2) New Drug Application 2007-04-04 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2009-03-26 view
CXSL0800042 安普利森钠注射用冻干粉 Lyophilized Biological Products(1) New Drug Application 2008-11-03 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd In Review 2008-10-29 view
CYHS1900625 巴氯芬注射液 baclofen Injection Chemical Drugs(3) Generic Drug 2019-09-05 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd In Review 2019-09-04 view
CYHS1900624 巴氯芬注射液 baclofen Injection Chemical Drugs(3) Generic Drug 2019-09-05 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd In Review 2019-09-04 view
CYHS1900623 巴氯芬注射液 baclofen Injection Chemical Drugs(3) Generic Drug 2019-09-05 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd In Review 2019-09-04 view
CYHS1900626 巴氯芬注射液 baclofen Injection Chemical Drugs(3) Generic Drug 2019-09-05 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd In Review 2019-09-04 view
CYHS1400570 恩替卡韦 entecavir Active ingredient Chemical Drugs(6) Generic Drug 2015-02-03 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd In Review 2015-02-02 view
CYHS0507532 氟马西尼 flumazenil Active ingredient Chemical Drugs(6) Generic Drug 2005-10-21 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2006-06-22 view
CYHS0507533 氟马西尼注射液 flumazenil Injection Chemical Drugs(6) Generic Drug 2005-10-21 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2008-11-12 view
CXHL0900263 注射用安普利森钠冻干粉 Lyophilized Chemical Drugs(1.1) New Drug Application 2009-07-30 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2010-07-27 view
X0304999 甲钴胺 mecobalamin Active ingredient Chemical Drugs(4) New Drug Application 2003-09-24 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2004-09-20 view
Y0305662 甲钴胺注射液 mecobalamin Injection Chemical Drugs(6) Generic Drug 2003-12-25 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2004-09-20 view
CYHB0805963 甲钴胺注射液 mecobalamin Injection Chemical Drugs Supplementary Application 2008-10-31 福建金山生物制药股份有限公司 Fuzhou Jinshan Biological Pharmaceutical Co Ltd Certificate Issued 2009-04-24 view