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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB0502360 注射用雷替曲塞 raltitrexed Lyophilized Chemical Drugs Supplementary Application 2005-11-23 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd;Beijing Dezhong Wanquan Pharmaceutical Technology Development Co Ltd Certificate Issued 2006-04-25 view
CXHL0500312 硫酸金刚烷胺氯化钠注射液 Adamantanamine Sulfate Injection Chemical Drugs(3.1) New Drug Application 2005-03-13 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2005-10-08 view
CXHL0600778 多烯磷脂酰胆碱软胶囊 Polyene Phosphatidyl choline Soft capsules Chemical Drugs(5) New Drug Application 2006-06-19 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2009-06-11 view
CXHL0700456 羟乙基淀粉130/0.4乳酸钠林格注射液 Hydroxyethyl Starch 130/0.4;sodium lactate Injection Chemical Drugs(5) New Drug Application 2008-01-23 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2010-08-27 view
CXHL0700458 注射用聚乙二醇降纤酶 Polyethylene glycol defibrase Lyophilized Chemical Drugs(1.1) New Drug Application 2007-12-25 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2008-07-08 view
CXHL0800002 羟乙基淀粉130/0.4醋酸钠林格注射液 Hydroxyethyl Starch 130/0.4;Sodium acetate Injection Chemical Drugs(5) New Drug Application 2008-03-13 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2010-09-13 view
CXHL0900294 盐酸莫西沙星葡萄糖注射液 moxifloxacin hydrochloride Injection Chemical Drugs(5) New Drug Application 2009-09-18 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-01-21 view
CXHL0900527 氨氯地平奥美沙坦酯片(Ⅰ) amlodipine besylate;olmesartan medoxomil Tablet Chemical Drugs(3.2) New Drug Application 2010-03-31 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2012-01-30 view
CXHL0900534 氨氯地平奥美沙坦酯片(Ⅱ) amlodipine besylate;olmesartan medoxomil Tablet Chemical Drugs(3.2) New Drug Application 2010-03-31 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2012-01-16 view
CXHL1000202 氢溴酸普拉格雷醋酸合物片 Prasugrel hydrobromide Tablet Chemical Drugs(4) New Drug Application 2010-06-23 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2013-11-15 view
CXHL1000203 氢溴酸普拉格雷醋酸合物片 Prasugrel hydrobromide Tablet Chemical Drugs(4) New Drug Application 2010-06-23 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2013-11-15 view
CXHL1200130 辛伐他汀烟酸缓释片(Ⅰ) nicotinic acid;simvastatin Tablet, extended release Chemical Drugs(3.2) New Drug Application 2012-04-11 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2014-04-15 view
CXHL1200131 辛伐他汀烟酸缓释片(Ⅱ) nicotinic acid;simvastatin Tablet, extended release Chemical Drugs(3.2) New Drug Application 2012-04-11 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2014-04-15 view
CXHL1300661 度他雄胺 dutasteride Active ingredient Chemical Drugs(3.1) New Drug Application 2013-08-28 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2015-12-30 view
CXHL1300662 度他雄胺胶囊 dutasteride Capsule Chemical Drugs(5) New Drug Application 2013-07-31 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2015-12-24 view
CXHL1300833 阿齐沙坦片 azilsartan Tablet Chemical Drugs(3.1) New Drug Application 2013-09-22 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-01-13 view
CXHL1300834 阿齐沙坦片 azilsartan Tablet Chemical Drugs(3.1) New Drug Application 2013-09-22 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-01-13 view
CXHL1400781 他达拉非片 tadalafil Tablet Chemical Drugs(3.4) New Drug Application 2014-08-21 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-03-10 view
CXHL1400782 他达拉非片 tadalafil Tablet Chemical Drugs(3.4) New Drug Application 2014-08-21 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-03-10 view
CXHL1400783 他达拉非 tadalafil Active ingredient Chemical Drugs(3.1) New Drug Application 2014-08-21 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-03-10 view