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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL01B83 葡萄糖酸锌喷鼻凝胶剂 Zinc gluconate Gel Chemical Drugs(4) New Drug Application 2001-11-07 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd In Approval 2006-07-20 view
CXL01B82 盐酸地尔硫卓注射液 diltiazem hydrochloride Injection Chemical Drugs(4) New Drug Application 2001-11-07 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2003-07-07 view
CXS20020172 盐酸格拉司琼葡萄糖注射液 Granisetron hydrochloride Injection Chemical Drugs(4) New Drug Application 2002-03-18 烟台同和医药科技有限公司青岛金峰制药有限公司 Certificate Issued 2003-11-03 view
CXS20020799 阿奇霉素葡萄糖注射液 azithromycin Injection Chemical Drugs(4) New Drug Application 2002-09-02 烟台同和医药科技有限公司青岛金峰制药有限公司 Approval Completed-Pending Certificated 2003-03-26 view
X0300940 甲磺酸帕珠沙星 pazufloxacin mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2003-12-25 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-03-19 view
X0300942 甲磺酸帕珠沙星氯化钠注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-12-25 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-03-19 view
X0300941 甲磺酸帕珠沙星注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-12-25 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-03-19 view
X0302204 硫酸头孢噻利 Cefoselis Sulfate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-03-15 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-08-16 view
X0302205 注射用硫酸头孢噻利 Cefoselis Sulfate Lyophilized Chemical Drugs(3.1) New Drug Application 2004-03-15 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-08-16 view
X0300946 复方盐酸西替利嗪伪麻缓释片 cetirizine hydrochloride;pseudoephedrine hydrochloride Tablet, extended release Chemical Drugs(3.2) New Drug Application 2004-03-15 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-07-05 view
X0300945 格列齐特缓释片 gliclazide Tablet, extended release Chemical Drugs(5) New Drug Application 2004-03-24 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-07-05 view
X0302945 注射用甲磺酸帕珠沙星 pazufloxacin mesylate Lyophilized Chemical Drugs(3.1) New Drug Application 2004-03-24 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2004-07-05 view
X0406305 尼莫地平滴丸 nimodipine Pellet Chemical Drugs(5) New Drug Application 2004-11-08 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2005-10-18 view
X0406920 左炔诺孕酮口腔崩解片 levonorgestrel Tablet Chemical Drugs(5) New Drug Application 2004-11-24 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2005-07-08 view
CXHL0500738 小儿氨酚那敏口腔崩解片 Tablet Chemical Drugs(5) New Drug Application 2005-06-19 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2006-07-27 view
CXHL0500987 异丙肌苷胶囊 isoprinosine Capsule Chemical Drugs(3.1) New Drug Application 2005-08-04 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2007-08-02 view
CXHL0600332 注射用雷贝拉唑钠 rabeprazole sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2006-05-21 烟台同和医药科技有限公司 Yantai Tonghe Medical Technology Co Ltd Certificate Issued 2010-01-14 view