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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHS1100277 盐酸普拉克索 pramipexole dihydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2012-04-11 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2013-09-23 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
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 Certificate Issued 2008-11-21 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
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
CXHR0800086 注射用盐酸帕洛诺司琼 palonosetron hydrochloride Lyophilized Chemical Drugs State Standards 2008-12-12 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2010-01-27 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
CYHS1301329 依折麦布辛伐他汀片 ezetimibe;Simvastatin Tablet Chemical Drugs(6) Generic Drug 2013-12-02 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-01-13 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 Certificate Issued 2008-05-09 view
CYHB1204233 盐酸昂丹司琼注射液 ondansetron hydrochloride Injection Chemical Drugs Supplementary Application 2012-06-25 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2013-10-29 view
CYHS1501468 恩他卡朋双多巴片(Ⅱ) carbidopa;entacapone;levodopa Tablet Chemical Drugs(6) Generic Drug 2016-05-11 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-10-24 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
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
CYHS1500435 替格瑞洛片 ticagrelor Tablet Chemical Drugs(6) Generic Drug 2015-05-13 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-03-10 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 Certificate Issued 2005-07-08 view
CYHS0900844 吸入用扎那米韦胶囊 zanamivir Powder for inhalation Chemical Drugs(6) Generic Drug 2009-11-17 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2010-02-11 view
CYHS1490016 盐酸普拉克索片 pramipexole dihydrochloride Tablet Chemical Drugs(6) Generic Drug 2014-02-19 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2016-03-17 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 Certificate Issued 2008-09-27 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
CYHB1103270 注射用阿莫西林钠克拉维酸钾 amoxicillin sodium;potassium clavulanate Lyophilized Chemical Drugs Supplementary Application 2012-02-21 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2013-04-11 view