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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYHB1100655 盐酸厄洛替尼片 erlotinib hydrochloride Tablet Chemical Drugs Supplementary Application 2011-07-21 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche SpA;Roche Registration Ltd Certificate Issued 2012-08-15 view
JYHB1401245 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs Supplementary Application 2014-09-09 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche SpA;Roche Registration Ltd Certificate Issued 2015-05-28 view
JYSB1600281 聚乙二醇干扰素α-2a注射液 peginterferon alfa-2a Injection Biological Products Supplementary Application 2017-01-18 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;F Hoffmann-La Roche Ltd(Switzerland);Roche Registration Ltd Certificate Issued 2017-06-21 view
JXHL0600300 甲磺酸沙奎那韦片 saquinavir mesylate Tablet Chemical Drugs(3.1) Import Drug Application 2006-11-21 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche Registration Ltd Certificate Issued 2009-04-15 view
JXSL1800071 利妥昔单抗注射液 rituximab Injection Biological Products Import Drug Application 2018-12-12 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche Pharma (Schweiz) AG In Review 2018-12-11 view
CYHB2100019 注射用头孢曲松钠 ceftriaxone sodium Lyophilized Chemical Drugs(原6) Supplementary Application 2021-01-06 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Shenzhen China Resources Gosun Pharmaceuticals Co Ltd In Review 2021-01-06 view
JYSB1100040 聚乙二醇干扰素α-2a注射液 peginterferon alfa-2a Injection Biological Products Supplementary Application 2011-03-16 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) Ltd Certificate Issued 2012-10-24 view
CYHB1400981 注射用头孢曲松钠 ceftriaxone sodium Lyophilized Chemical Drugs Supplementary Application 2014-03-11 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2015-07-27 view
CYHB1507132 注射用头孢曲松钠 ceftriaxone sodium Lyophilized Chemical Drugs Supplementary Application 2015-11-09 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2016-10-11 view
CYHS0508094 卡培他滨片 capecitabine Tablet Chemical Drugs(6) Generic Drug 2005-12-02 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2007-02-26 view
JYHZ1800184 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs License Renew 2018-07-02 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Delpharm Milano Srl;Roche Pharma (Schweiz) AG Certificate Issued 2018-11-26 view
JYSB2000393 重组人促红素-β注射液(CHO细胞) Recombinant Human Erythropoietin β(CHO Cell) Injection Biological Products Supplementary Application 2020-08-21 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Filed 2020-09-01 view
JYSB1000129 利妥昔单抗注射液 rituximab Injection Biological Products Supplementary Application 2010-08-06 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Certificate Issued 2012-02-17 view
CYHB1303242 注射用头孢曲松钠 ceftriaxone sodium Lyophilized Chemical Drugs Supplementary Application 2013-05-21 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2013-11-14 view
JYHB1800577 奥利司他胶囊 orlistat Capsule Chemical Drugs Supplementary Application 2018-05-28 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche SpA;Cheplapharm Arzneimittel GmbH Certificate Issued 2018-06-25 view
JXSL0900052 贝伐人源化单抗注射液 bevacizumab Injection Biological Products Import Drug Application 2009-08-05 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche Pharma (Schweiz) Ltd Certificate Issued 2010-07-21 view
JYHB1900986 骨化三醇胶丸 calcitriol Soft capsules Chemical Drugs Supplementary Application 2019-08-17 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Roche Pharma (Schweiz) AG;Catalent Germany Eberbach GmbH Certificate Issued 2019-10-10 view
H20020135 去氧氟尿苷 doxifluridine Active ingredient Chemical Drugs Import Drug Application 2002-06-04 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-07-08 view
JYHB2000570 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs Supplementary Application 2020-05-18 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;Delpharm Milano Srl;Roche Pharma (Schweiz) AG Certificate Issued 2020-08-10 view
JYHB0900936 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs Supplementary Application 2009-11-25 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) Ltd Filed 2010-01-08 view