Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
JXFL1200029 | 粉状巴西棕榈蜡#120NF | Excipients | Other | Import Drug Application | 2012-10-23 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2016-03-29 | view | |
JXFL1300014 | 白凡士林 | Other | Other | Import Drug Application | 2013-09-06 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2017-04-18 | view | |
JXHL0600286 | 凡德他尼片 | vandetanib | Tablet | Chemical Drugs(1.1) | Import Drug Application | 2006-11-08 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2008-04-10 | view |
JXHL0700184 | MK-0518 | raltegravir potassium | Active ingredient | Chemical Drugs(1.1) | Import Drug Application | 2007-07-18 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2008-11-24 | view |
JXHL0700191 | 注射用他拉泊芬钠 | talaporfin sodium | Lyophilized | Chemical Drugs(1.1) | Import Drug Application | 2007-07-18 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2009-02-04 | view |
JXHL0700277 | 阿贝莫司钠注射液 | abetimus | Injection | Chemical Drugs(1.1) | Import Drug Application | 2007-09-25 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2008-07-16 | view |
JXHL0800036 | 注射用坎格雷洛 | cangrelor | Lyophilized | Chemical Drugs(1.1) | Import Drug Application | 2008-01-25 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2009-04-08 | view |
JXHL0800050 | 注射用坎格雷洛 | cangrelor | Lyophilized | Chemical Drugs(1.1) | Import Drug Application | 2008-02-18 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2008-11-27 | view |
JXHL0900130 | Adentri(IV) | Other | Chemical Drugs | Import Drug Application | 2009-04-30 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2010-07-06 | view | |
JXHL1000060 | 贝前列素钠缓释片 | beraprost sodium | Tablet, extended release | Chemical Drugs | Import Drug Application | 2010-03-05 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2011-02-21 | view |
JXHL1200308 | HKI-272胶囊 | neratinib maleate | Capsule | Chemical Drugs | Import Drug Application | 2012-11-08 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2013-04-23 | view |
JXHL1200309 | HKI-272胶囊 | neratinib maleate | Capsule | Chemical Drugs | Import Drug Application | 2012-10-11 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2013-04-23 | view |
JXHL1200336 | HKI-272片剂 | neratinib maleate | Tablet | Chemical Drugs | Import Drug Application | 2012-11-08 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2013-04-23 | view |
JXHL1200337 | HKI-272片剂 | neratinib maleate | Tablet | Chemical Drugs | Import Drug Application | 2012-10-23 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2013-04-23 | view |
JXHL1200338 | HKI-272片剂 | neratinib maleate | Tablet | Chemical Drugs | Import Drug Application | 2012-11-08 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2013-04-23 | view |
JXHL1200339 | HKI-272片剂 | neratinib maleate | Tablet | Chemical Drugs | Import Drug Application | 2012-10-23 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2013-04-23 | view |
JXHL1200343 | HKI-272片剂 | neratinib maleate | Tablet | Chemical Drugs | Import Drug Application | 2012-11-08 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2013-04-23 | view |
JXHL1300302 | Sofosbuvir 片 | Sofosbuvir | Tablet | Chemical Drugs | Import Drug Application | 2013-08-19 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2015-01-29 | view |
JXHL1300402 | 注射用艾塞那肽微球 | Exenatide | Lyophilized | Chemical Drugs | Import Drug Application | 2013-10-22 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | Certificate Issued | 2015-03-02 | view |
JXHL1900012 | 沙芬酰胺片 | safinamide mesylate | Tablet | Chemical Drugs(5.1) | Import Drug Application | 2019-01-28 | 精鼎医药研究开发(上海)有限公司 | Parexel China Co Ltd | In Review | 2019-01-25 | view |