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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL0700389 米屈肼胶囊 meldonium Capsule Chemical Drugs(3.1) Import Drug Application 2007-12-18 JSC Grindeks Jsc Grindeks Certificate Issued 2009-09-25 view
JXHL0700344 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) Import Drug Application 2007-11-07 JSC Grindeks Jsc Grindeks Certificate Issued 2009-09-25 view
CXHS0502517 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2005-12-02 保定三九济世生物药业有限公司 Hebei Zhitong Biopharmaceutical Co Ltd Certificate Issued 2008-08-14 view
CXHL0501934 注射用米屈肼 meldonium Lyophilized Chemical Drugs(3.1) New Drug Application 2005-12-02 保定三九济世生物药业有限公司 Hebei Zhitong Biopharmaceutical Co Ltd Certificate Issued 2008-08-13 view
CXHB0900214 注射用米屈肼 meldonium Lyophilized Chemical Drugs Supplementary Application 2009-07-16 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2010-03-04 view
X0300101 米屈肼胶囊 meldonium Capsule Chemical Drugs(3.1) New Drug Application 2003-12-17 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-04-29 view
CXHB0600544 米屈肼胶囊 meldonium Capsule Chemical Drugs Supplementary Application 2006-05-30 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2007-08-02 view
X0403934 米屈肼口服溶液 meldonium Oral solution Chemical Drugs(3.1) New Drug Application 2004-07-15 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-02-25 view
CXHL0500058 注射用米屈肼 meldonium Lyophilized Chemical Drugs(3.1) New Drug Application 2005-02-17 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-10-09 view
CXHB0600546 米屈肼注射液 meldonium Injection Chemical Drugs Supplementary Application 2006-05-30 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2007-03-05 view
X0300100 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2003-12-17 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-04-29 view
X0300102 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2003-12-17 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-04-29 view
CXHL0500997 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2005-06-25 山西泰盛制药有限公司 Shanxi Zhendong Taisheng Pharmaceutical Co Ltd Certificate Issued 2006-06-28 view
CXHL0500996 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2005-06-25 山西泰盛制药有限公司 Shanxi Zhendong Taisheng Pharmaceutical Co Ltd Certificate Issued 2006-06-28 view
CXHL0800175 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2008-10-31 扬子江药业集团北京海燕药业有限公司 Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co Ltd Certificate Issued view
CXHL0800176 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2008-10-31 扬子江药业集团北京海燕药业有限公司 Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
X0406383 米屈肼氯化钠注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2004-11-08 沈阳中海生物技术开发有限公司 Shenyang Zhonghai Biological Technology Development Co Ltd Certificate Issued 2007-08-02 view
X0406382 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-11-08 沈阳中海生物技术开发有限公司 Shenyang Zhonghai Biological Technology Development Co Ltd Certificate Issued 2006-09-06 view
X0406385 米屈肼口服液 meldonium Oral solution Chemical Drugs(3.1) New Drug Application 2004-11-08 沈阳中海生物技术开发有限公司 Shenyang Zhonghai Biological Technology Development Co Ltd Certificate Issued 2006-09-06 view
X0406384 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2004-11-08 沈阳中海生物技术开发有限公司 Shenyang Zhonghai Biological Technology Development Co Ltd Certificate Issued 2006-09-06 view