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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
AS20000016 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Import Drug Application 2000-01-01 美国礼来亚洲公司北京办事处 Approval Completed-Pending Certificated view
CSL20020035 双时相重组赖脯胰岛素注射液75/25 Injection Biological Products(2) New Drug Application 2002-06-03 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Approval Completed-Pending Certificated 2003-01-23 view
CSL20020034 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(2) New Drug Application 2002-06-03 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2003-06-20 view
X0401022 双时相重组赖脯胰岛素注射液75/25 Injection Biological Products Supplementary Application 2004-03-16 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2004-07-19 view
CYSS0500012 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2006-02-05 view
CYSS0500011 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2006-02-05 view
CXSB0700036 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2007-09-12 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2008-06-20 view
CYSB1000532 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2010-11-26 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2011-09-29 view
CYSB1000533 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2010-11-26 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2011-09-29 view
CXSL1100041 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) New Drug Application 2011-10-19 江苏万邦生化医药股份有限公司 Wanbang Biopharmaceuticals Certificate Issued 2013-09-13 view
CXSS1500012 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) New Drug Application 2015-11-03 江苏万邦生化医药股份有限公司 Wanbang Biopharmaceuticals Certificate Issued 2016-04-21 view
CXSL1700132 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) New Drug Application 2018-03-14 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2018-10-08 view
CYSB1700229 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2018-06-15 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2019-05-27 view
CYSB2000015 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2020-02-14 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-03-26 view
CXSS2000034 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) New Drug Application 2020-06-28 江苏万邦生化医药集团有限责任公司 Wanbang Biopharmaceuticals In Review 2020-06-24 view
CYSB2000096 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2020-05-18 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-07-27 view
CYSB2000095 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2020-05-18 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-07-27 view