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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS20020302 复方甘露醇注射液 mannitol Injection Chemical Drugs(4) New Drug Application 2002-04-28 江苏正大天晴药业股份有限公司南京正大天晴制药有限公司 Certificate Issued 2002-12-03 view
CXS20020301 复方甘露醇注射液 mannitol Injection Chemical Drugs(4) New Drug Application 2002-04-28 江苏正大天晴药业股份有限公司南京正大天晴制药有限公司 Certificate Issued 2002-12-03 view
CXS20020372 帕米膦酸二钠葡萄糖注射液 pamidronate disodium Injection Chemical Drugs(4) New Drug Application 2004-04-28 江苏正大天晴药业股份有限公司上海医药工业研究院 南京正大天晴制药有限公司 Certificate Issued 2004-08-30 view
CYHS0900602 盐酸阿扎司琼注射液 azasetron hydrochloride Injection Chemical Drugs(6) Generic Drug 2010-01-20 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2011-02-15 view
CYHB1950109 注射用帕瑞昔布钠 parecoxib sodium Lyophilized Chemical Drugs Supplementary Application 2019-01-29 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2021-01-08 view
CYHS1301563 琥珀酸索利那新片 solifenacin succinate Tablet Chemical Drugs(6) Generic Drug 2014-04-24 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-02-03 view
CXZS0602954 益脉康滴丸 Pellet Chinese Herbal Medicine(8) New Drug Application 2006-06-16 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2007-07-11 view
CYHS1700349 他达拉非片 tadalafil Tablet Chemical Drugs(4) Generic Drug 2018-01-08 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2019-07-02 view
CYHB1205386 注射用泮托拉唑钠 pantoprazole sodium Lyophilized Chemical Drugs Supplementary Application 2012-12-12 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2013-07-12 view
CYHS2000829 甲磺酸沙非胺片 safinamide mesylate Tablet Chemical Drugs(3) Generic Drug 2020-12-03 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2021-08-19 view
CYHS1501277 盐酸美金刚 memantine hydrochloride Active ingredient Chemical Drugs(6) Generic Drug 2016-03-14 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd In Review 2016-03-11 view
X0402709 参麦舒欣滴丸 Pellet Chinese Herbal Medicine(5) New Drug Application 2004-05-31 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2007-12-29 view
CYHB1906038 厄贝沙坦氢氯噻嗪片 hydrochlorothiazide;irbesartan Tablet Chemical Drugs Supplementary Application 2019-11-05 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2020-01-14 view
CYHS1401699 琥珀酸普芦卡必利片 prucalopride succinate Tablet Chemical Drugs(6) Generic Drug 2015-03-28 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-03-10 view
Y0301943 甘油果糖注射液 Fructose;glycerol Injection Chemical Drugs(6) Generic Drug 2003-07-07 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2004-03-19 view
CXHS1000192 恩替卡韦胶囊 entecavir Capsule Chemical Drugs(5) New Drug Application 2010-09-06 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2012-06-13 view
CYHB1950411 注射用泮托拉唑钠 pantoprazole sodium Lyophilized Chemical Drugs Supplementary Application 2019-06-10 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2020-11-30 view
CYHS1400787 他达拉非片 tadalafil Tablet Chemical Drugs(6) Generic Drug 2014-08-22 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-03-10 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
CYHS1700727 阿哌沙班片 apixaban Tablet Chemical Drugs(4) Generic Drug 2018-08-22 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd Certificate Issued 2020-07-29 view