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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXB01196 利巴韦林分散片 ribavirin Tablet Chemical Drugs(4) New Drug Application 2001-06-05 南京东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2003-04-21 view
CXB20020713 赖诺普利胶囊 lisinopril Capsule Chemical Drugs(4) New Drug Application 2002-10-29 南京东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-11-24 view
CXHB0500813 依达拉奉注射液 edaravone Injection Chemical Drugs Supplementary Application 2005-06-19 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2005-12-21 view
CXHB0500814 依达拉奉注射液 edaravone Injection Chemical Drugs Supplementary Application 2005-06-19 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2005-12-21 view
CXHB0502165 富马酸氯马斯汀干混悬剂 clemastine fumarate Suspension Chemical Drugs Supplementary Application 2006-02-07 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2007-07-11 view
CXHB0502561 盐酸曲马多分散片 tramadol hydrochloride Tablet Chemical Drugs Supplementary Application 2006-04-19 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2007-02-08 view
CXHB0601218 依达拉奉注射液 edaravone Injection Chemical Drugs Supplementary Application 2007-03-02 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2008-06-01 view
CXHB0700525 马来酸氨氯地平片 Amlodipine maleate Tablet Chemical Drugs Supplementary Application 2007-07-09 先声药业有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-04-27 view
CXHB0801376 美洛昔康 meloxicam Active ingredient Chemical Drugs Supplementary Application 2008-11-26 先声药业有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-04-21 view
CXHB0801609 蒙脱石分散片 diosmectite Tablet Chemical Drugs Supplementary Application 2008-12-26 先声药业有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-06-08 view
CXHB0900542 注射用比阿培南 biapenem Lyophilized Chemical Drugs Supplementary Application 2009-08-17 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2010-12-29 view
CXHB0900588 吸入用扎那米韦胶囊 zanamivir Powder for inhalation Chemical Drugs Supplementary Application 2009-08-17 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2010-05-19 view
CXHB1300051 阿莫西林分散片 amoxicillin Tablet Chemical Drugs Supplementary Application 2013-10-30 先声药业有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2014-07-10 view
CXHB1500130 注射用奈达铂 nedaplatin Lyophilized Chemical Drugs Supplementary Application 2015-11-26 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-09-04 view
CXHB2101002 注射用多西他赛聚合物胶束 Docetaxel Lyophilized Chemical Drugs(2.2) Supplementary Application 2021-04-07 Simcere Pharmaceutical Co Ltd view
CXHL0600784 复方α-酮酸咀嚼片 Tablet Chemical Drugs(5) New Drug Application 2006-08-15 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2007-08-02 view
CXHL0700180 扎那米韦 zanamivir Active ingredient Chemical Drugs(3.1) New Drug Application 2007-09-26 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2008-11-07 view
CXHL0700181 吸入用扎那米韦胶囊 zanamivir Powder for inhalation Chemical Drugs(3.1) New Drug Application 2007-09-26 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2008-11-07 view
CXHL0800114 依达拉奉注射液 edaravone Injection Chemical Drugs(1.6) New Drug Application 2008-06-04 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-06-17 view
CXHL0800115 依达拉奉注射液 edaravone Injection Chemical Drugs(1.6) New Drug Application 2008-06-04 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-06-17 view