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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
X0406296 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-11-08 黑龙江省智诚医药科技有限公司 Heilongjiang Zhicheng Medicine Technology Co Ltd Certificate Issued 2005-12-08 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
X0406298 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2004-11-08 黑龙江省智诚医药科技有限公司 Heilongjiang Zhicheng Medicine Technology Co Ltd Certificate Issued 2005-12-08 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
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
X0406297 米屈肼胶囊 meldonium Capsule Chemical Drugs(3.1) New Drug Application 2004-11-08 黑龙江省智诚医药科技有限公司 Heilongjiang Zhicheng Medicine Technology Co Ltd Certificate Issued 2005-12-08 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
CXHL0500251 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2005-02-24 沈阳金峰医药科技有限公司 Shenyang Jinfeng Pharmaceutical Technology Co Ltd Certificate Issued 2005-11-03 view
CXHL0500252 米屈肼胶囊 meldonium Capsule Chemical Drugs(3.1) New Drug Application 2005-02-28 沈阳金峰医药科技有限公司 Shenyang Jinfeng Pharmaceutical Technology Co Ltd Certificate Issued 2005-11-03 view
CXHL0500253 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2005-02-28 沈阳金峰医药科技有限公司 Shenyang Jinfeng Pharmaceutical Technology Co Ltd Certificate Issued 2005-11-03 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
CXHL0501655 米屈肼 meldonium Active ingredient Chemical Drugs(3.1) New Drug Application 2005-08-31 海南海神同洲制药有限公司 Hainan Haishen Tongzhou Pharmaceutical Co Ltd Certificate Issued 2006-06-28 view
CXHL0501657 米屈肼注射液 meldonium Injection Chemical Drugs(3.1) New Drug Application 2005-08-31 海南海神同洲制药有限公司 Hainan Haishen Tongzhou Pharmaceutical Co Ltd In Review 2007-06-01 view
CXHL0501656 米屈肼胶囊 meldonium Capsule Chemical Drugs(3.1) New Drug Application 2005-08-31 海南海神同洲制药有限公司 Hainan Haishen Tongzhou Pharmaceutical Co Ltd Certificate Issued 2006-06-28 view