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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2000425 奥贝胆酸镁片 Obeticholic acid Magnesium Tablet Chemical Drugs(2.1) New Drug Application 2020-09-01 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-08-31 view
CXHL1900365 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2019-11-22 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-11-21 view
CXHL1900442 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2020-01-01 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-12-31 view
CXHL1900185 盐酸杰克替尼乳膏 jaktinib hydrochloride Cream Chemical Drugs(1) New Drug Application 2019-06-10 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd;Shanghai Zejing Pharmaceutical Technology Co Ltd In Review 2019-06-06 view
CXHS2000010 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs(1) New Drug Application 2020-05-15 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-05-14 view
CXHL1900353 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2019-11-13 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-11-11 view
CXHL1900406 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2019-12-10 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-12-09 view
CXHL1900181 盐酸杰克替尼乳膏 jaktinib hydrochloride Cream Chemical Drugs(1) New Drug Application 2019-06-10 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd;Shanghai Zejing Pharmaceutical Technology Co Ltd In Review 2019-06-06 view
CXHL2000166 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs(1) New Drug Application 2020-04-27 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-04-26 view
CXHL1900249 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs(1) New Drug Application 2019-08-22 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-08-20 view
CXHL1900366 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2019-11-22 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-11-21 view
CXHL1900441 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2020-01-01 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-12-31 view
CXHL1900184 盐酸杰克替尼乳膏 jaktinib hydrochloride Cream Chemical Drugs(1) New Drug Application 2019-06-10 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd;Shanghai Zejing Pharmaceutical Technology Co Ltd In Review 2019-06-06 view
CXHL2000203 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs(1) New Drug Application 2020-05-09 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-05-08 view
CXHL1900352 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2019-11-13 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-11-11 view
CXHB2000137 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) Supplementary Application 2020-12-14 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-12-11 view
CXHL1900405 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2019-12-10 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-12-09 view
CXHL2000055 甲苯磺酸多纳非尼片 donafenib tosylate Tablet Chemical Drugs(1) New Drug Application 2020-02-25 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-02-24 view
CXHL1900276 盐酸杰克替尼片 jaktinib hydrochloride Tablet Chemical Drugs(1) New Drug Application 2019-08-07 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2019-08-06 view
CXHL2000424 奥贝胆酸镁片 Obeticholic acid Magnesium Tablet Chemical Drugs(2.1) New Drug Application 2020-09-01 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-08-31 view