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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1800023 奥卡替尼胶囊 alkotinib Capsule Chemical Drugs(1) New Drug Application 2018-02-26 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2018-06-08 view
CXHL1800022 奥卡替尼胶囊 alkotinib Capsule Chemical Drugs(1) New Drug Application 2018-02-26 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2018-06-08 view
CXHL1800021 奥卡替尼 alkotinib Active ingredient Chemical Drugs(1) New Drug Application 2018-02-26 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2018-02-24 view
CXSL1700204 注射用重组人促甲状腺激素 thyrotropin alfa Lyophilized Biological Products(7) New Drug Application 2018-02-07 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2018-11-09 view
CXHL1600113 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1.1) New Drug Application 2016-05-10 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2016-12-15 view
CXHL1600114 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1.1) New Drug Application 2016-05-03 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2016-12-15 view
CXHL1600112 杰克替尼二盐酸盐一水合物 jaktinib hydrochloride Active ingredient Chemical Drugs(1.1) New Drug Application 2016-05-03 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2016-12-08 view
CXHB1500034 甲苯磺酸多纳非尼 donafenib tosylate Active ingredient Chemical Drugs Supplementary Application 2015-04-21 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2015-10-29 view
CXHB1500037 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs Supplementary Application 2015-04-21 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2015-10-20 view
CXHB1500036 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs Supplementary Application 2015-04-21 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2015-10-20 view
CXHB1500035 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs Supplementary Application 2015-04-21 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2015-10-29 view
CXSL1400062 外用重组人凝血酶(CHO细胞) thrombin alfa Other Biological Products(7) New Drug Application 2014-08-07 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2016-12-30 view
CXHB1400005 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs Supplementary Application 2014-03-11 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2014-12-01 view
CXSL1200089 外用重组人凝血酶(CHO细胞) thrombin alfa Other Biological Products(7) New Drug Application 2013-04-10 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2017-07-17 view
CXHL1100608 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs(1.1) New Drug Application 2011-12-28 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2012-11-29 view
CXHL1100606 甲苯磺酸多纳非尼 donafenib tosylate Active ingredient Chemical Drugs(1.1) New Drug Application 2011-12-28 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2012-11-29 view
CXHL1100607 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs(1.1) New Drug Application 2011-12-28 苏州泽璟生物制药有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd Certificate Issued 2012-11-29 view