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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS1300095 依折麦布片 ezetimibe Tablet Chemical Drugs(6) Generic Drug 2013-04-22 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2015-12-24 view
CXZS0501370 益母片 Tablet Chinese Herbal Medicine(9) New Drug Application 2005-05-12 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd;Jiangsu Xiansheng Medicament Research Co Ltd Certificate Issued 2008-11-21 view
CYHS1600176 盐酸普拉克索片 pramipexole dihydrochloride Tablet Chemical Drugs(4) Generic Drug 2017-02-03 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2020-11-03 view
CYHB1104525 培美曲塞二钠 pemetrexed disodium Active ingredient Chemical Drugs Supplementary Application 2011-06-01 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2012-02-09 view
X0301856 阿莫西林克拉维酸钾颗粒 amoxicillin;potassium clavulanate Granule Chemical Drugs Supplementary Application 2003-04-08 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2003-12-15 view
CXHL1500775 索非布韦 Sofosbuvir Active ingredient Chemical Drugs(3.1) New Drug Application 2015-07-31 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CYHB1311406 扎那米韦吸入粉雾剂 zanamivir Powder for inhalation Chemical Drugs Supplementary Application 2014-04-09 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2014-11-21 view
CXHS0601483 注射用比阿培南 biapenem Lyophilized Chemical Drugs(3.1) New Drug Application 2006-12-18 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd;Hainan Simcere Pharmaceutical Co Ltd;Chengdu Entry S&T Development Co Ltd;Jiangsu Xiansheng Medicament Research Co Ltd Certificate Issued 2008-05-09 view
CYHS2000305 哌柏西利胶囊 palbociclib Capsule Chemical Drugs(4) Generic Drug 2020-05-07 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2021-10-29 view
CYHS1300595 注射用硼替佐米 bortezomib Lyophilized Chemical Drugs(6) Generic Drug 2013-08-20 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2019-07-02 view
CYHS0504190 单硝酸异山梨酯注射液 isosorbide mononitrate Injection Chemical Drugs(6) Generic Drug 2005-07-20 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2006-01-18 view
CYHB1111420 注射用培美曲塞二钠 pemetrexed disodium Lyophilized Chemical Drugs Supplementary Application 2012-04-12 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2013-07-29 view
X0403202 小儿解感合剂 Oral solution Chinese Herbal Medicine(9) New Drug Application 2004-06-16 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd;Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2005-07-08 view
CXHL1502097 依达拉奉注射液 edaravone Injection Chemical Drugs(3.4) New Drug Application 2016-01-15 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-11-23 view
CYHB1501461 注射用培美曲塞二钠 pemetrexed disodium Lyophilized Chemical Drugs Supplementary Application 2015-03-28 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-04-07 view
CXHS0700260 注射用盐酸帕洛诺司琼 palonosetron hydrochloride Lyophilized Chemical Drugs(3.1) New Drug Application 2007-12-25 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd;Hangzhou Rongli Pharmaceutical Technology Co Ltd;Jiangsu Xiansheng Medicament Research Co Ltd Certificate Issued 2008-09-27 view
CYHS2000568 注射用盐酸苯达莫司汀 bendamustine hydrochloride Lyophilized Chemical Drugs(4) Generic Drug 2020-08-20 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2021-10-08 view
CXHS1300346 甲磺酸伊马替尼 imatinib mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2014-01-03 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd;Jiangsu Simcere Pharmaceutical Co Ltd;Jiangsu Xiansheng Medicament Research Co Ltd Certificate Issued 2016-08-23 view
CYHS0508525 多烯磷脂酰胆碱注射液 Polyene Phosphatidyl choline Injection Chemical Drugs(6) Generic Drug 2005-12-15 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-06-11 view
CYHB1850014 瑞舒伐他汀钙片 rosuvastatin calcium Tablet Chemical Drugs Supplementary Application 2018-02-14 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2018-10-22 view