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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHS0601047 氢溴酸加兰他敏口腔崩解片 GALANTAMINE HYDROBROMIDE Tablet Chemical Drugs(5) New Drug Application 2006-06-27 天津天达药业有限公司 Tianjin Meihua Biomedical Technology Co Ltd Certificate Issued 2008-12-09 view
CYHS0507085 阿奇霉素分散片 azithromycin Tablet Chemical Drugs(6) Generic Drug 2005-10-21 天津天达药业有限公司 Tianjin Meihua Biomedical Technology Co Ltd Certificate Issued 2006-06-21 view
CXHS0601467 瑞舒伐他汀钙片 rosuvastatin calcium Tablet Chemical Drugs(3.1) New Drug Application 2007-03-19 天津天达药业有限公司 Tianjin Meihua Biomedical Technology Co Ltd Certificate Issued 2009-04-07 view
CXHR0900115 瑞舒伐他汀钙片 rosuvastatin calcium Tablet Chemical Drugs State Standards 2009-06-24 天津天达药业有限公司 Tianjin Meihua Biomedical Technology Co Ltd Certificate Issued 2010-06-02 view
CYHS0502782 利巴韦林颗粒 ribavirin Granule Chemical Drugs(6) Generic Drug 2005-07-20 天津天达药业有限公司 Tianjin Meihua Biomedical Technology Co Ltd Certificate Issued 2006-04-28 view
CXHR0900116 瑞舒伐他汀钙片 rosuvastatin calcium Tablet Chemical Drugs State Standards 2009-06-24 天津天达药业有限公司 Tianjin Meihua Biomedical Technology Co Ltd Certificate Issued 2010-06-02 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
CYHS2000169 哌柏西利胶囊 palbociclib Capsule Chemical Drugs(4) Generic Drug 2020-03-06 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2021-10-29 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
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
CYHS1600190 盐酸苯达莫司汀 bendamustine hydrochloride Active ingredient Chemical Drugs(3) Generic Drug 2017-01-13 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd In Review 2017-01-11 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
CYHB0801802 阿莫西林分散片 amoxicillin Tablet Chemical Drugs Supplementary Application 2008-10-07 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2009-04-08 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
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
CYHB2005483 依达拉奉注射液 edaravone Injection Chemical Drugs Supplementary Application 2020-07-04 南京先声东元制药有限公司 Simcere Pharmaceutical Co Ltd Certificate Issued 2020-09-02 view
CYHS0504189 葛根素注射液 Puerarin 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 2008-05-15 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 Certificate Issued 2016-08-23 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