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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1400926 阿齐沙坦氨氯地平片(Ⅱ) amlodipine;azilsartan Tablet Chemical Drugs(3.2) New Drug Application 2014-07-24 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-02-19 view
CXHL1400925 阿齐沙坦氨氯地平片(Ⅰ) amlodipine;azilsartan Tablet Chemical Drugs(3.2) New Drug Application 2014-07-24 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-02-19 view
JXSL1300046 阿巴西普注射液 abatacept Injection Biological Products Import Drug Application 2013-07-08 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd;Bristol-Myers Squibb Company Certificate Issued 2015-11-06 view
CXSL1400128 重组全人源抗EGFR单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-02-05 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
X0400714 连芍清胆胶囊 Capsule Chinese Herbal Medicine(6) New Drug Application 2004-11-04 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
CXHL1300570 萘二磺酸普拉格雷片 prasugrel napadisilate Tablet Chemical Drugs(4) New Drug Application 2013-08-07 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2017-03-15 view
CXHL1300569 萘二磺酸普拉格雷片 prasugrel napadisilate Tablet Chemical Drugs(4) New Drug Application 2013-08-07 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2017-03-15 view
CXHL1300568 萘二磺酸普拉格雷 prasugrel napadisilate Active ingredient Chemical Drugs(4) New Drug Application 2013-08-07 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2017-03-15 view
CXHL1501586 色瑞替尼 ceritinib Active ingredient Chemical Drugs(3.1) New Drug Application 2015-09-09 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-23 view
CXHL1300515 盐酸维拉佐酮片 vilazodone hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2013-07-01 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2015-12-30 view
CXHL1300517 盐酸维拉佐酮片 vilazodone hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2013-07-01 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2015-12-30 view
CXHL1300516 盐酸维拉佐酮片 vilazodone hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2013-07-01 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2015-12-30 view
CXHL1300514 盐酸维拉佐酮 vilazodone hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2013-07-01 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2015-12-24 view
CXHL1400948 盐酸替吡嘧啶 Active ingredient Chemical Drugs(3.1) New Drug Application 2014-07-24 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-03-10 view
CXHL1500892 盐酸帕洛诺司琼软胶囊 palonosetron hydrochloride Soft capsules Chemical Drugs(3.3) New Drug Application 2015-05-19 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CXHL1502054 甲磺酸乐伐替尼胶囊 Lenvatinib mesylate Capsule Chemical Drugs(3.1) New Drug Application 2016-02-16 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-11-23 view
CXHL1502053 甲磺酸乐伐替尼胶囊 Lenvatinib mesylate Capsule Chemical Drugs(3.1) New Drug Application 2016-02-16 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-11-23 view
CXHL1502052 甲磺酸乐伐替尼 Lenvatinib mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2016-02-16 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-11-23 view
CXSL1400111 注射用人鼠嵌合抗TNFα单克隆抗体 Lyophilized Biological Products(2) New Drug Application 2015-01-06 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-04-07 view
JXHL2100040 注射用Trilaciclib trilaciclib hydrochloride Lyophilized Chemical Drugs(1) Import Drug Application 2021-02-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd;G1 Therapeutics Inc In Review 2021-02-03 view