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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL2100110 注射用Trilaciclib trilaciclib hydrochloride Lyophilized Chemical Drugs(2.4) Import Drug Application 2021-04-01 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd;G1 Therapeutics Inc In Review 2021-03-31 view
CXSB2100015 注射用BD0801 Lyophilized Biological Products(1) Supplementary Application 2021-03-10 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2021-03-09 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
CXSL2000336 注射用BD0801 Lyophilized Biological Products(1) New Drug Application 2020-12-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2020-12-02 view
JXHL2000304 注射用Trilaciclib trilaciclib hydrochloride Lyophilized Chemical Drugs(1) Import Drug Application 2020-11-18 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd;G1 Therapeutics Inc In Review 2020-11-17 view
CXHL2000462 SIM1909-13片 SIM-1909-13 Tablet Chemical Drugs(1) New Drug Application 2020-09-16 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2020-09-16 view
CXHL2000463 SIM1909-13片 SIM-1909-13 Tablet Chemical Drugs(1) New Drug Application 2020-09-16 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd In Review 2020-09-16 view
JXHL1700057 沙美特罗替卡松粉吸入剂 fluticasone propionate;salmeterol xinafoate Inhalation Chemical Drugs(5.2) Import Drug Application 2017-03-27 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd;Celon Pharma SA Certificate Issued 2018-09-21 view
JXHL1700056 沙美特罗替卡松粉吸入剂 fluticasone propionate;salmeterol xinafoate Inhalation Chemical Drugs(5.2) Import Drug Application 2017-03-27 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd;Celon Pharma SA Certificate Issued 2018-09-21 view
JXHL1700058 沙美特罗替卡松粉吸入剂 fluticasone propionate;salmeterol xinafoate Inhalation Chemical Drugs(5.2) Import Drug Application 2017-03-27 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd;Celon Pharma SA Certificate Issued 2018-09-21 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
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
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
CXHL1501588 泊沙康唑 posaconazole 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
CXHL1501589 泊沙康唑注射液 posaconazole Injection Chemical Drugs(3.3) 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
CXHL1501126 乙磺酸尼达尼布软胶囊 nintedanib esylate Soft capsules Chemical Drugs(3.1) New Drug Application 2015-06-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
CXHL1501125 乙磺酸尼达尼布软胶囊 nintedanib esylate Soft capsules Chemical Drugs(3.1) New Drug Application 2015-06-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
CXHL1501039 奈妥匹坦帕洛诺司琼胶囊 netupitant;palonosetron Capsule Chemical Drugs(3.2) New Drug Application 2015-06-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CXHL1501038 奈妥匹坦 netupitant Active ingredient Chemical Drugs(3.1) New Drug Application 2015-06-03 江苏先声药业有限公司 Jiangsu Simcere Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view