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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
J0300014 复合维生素 Other Chemical Drugs(3.1) Import Drug Application 2003-01-21 罗氏制药有限公司 Roche Holding AG;Shanghai Roche Pharmaceutical Co Ltd;Roche Products Ltd Approval Completed-Pending Certificated 2004-01-16 view
JXHL0500072 埃罗替尼薄膜衣片 erlotinib hydrochloride Tablet Chemical Drugs(1.1) Import Drug Application 2005-04-27 罗氏制药有限公司 Roche Holding AG Certificate Issued 2005-09-21 view
JTS1900038 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Disposable Import Drug Application 2019-08-03 瑞士罗氏制药有限公司F. Hoffman-La Roche Ltd F Hoffmann-La Roche Ltd(Switzerland);TOT Biopharm Co Ltd;Roche Registration GmbH Certificate Issued 2019-09-04 view
JTS1900039 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Disposable Import Drug Application 2019-08-03 瑞士罗氏制药有限公司 F. Hoffman-La Roche Ltd. F Hoffmann-La Roche Ltd(Switzerland);TOT Biopharm Co Ltd;Roche Registration GmbH Certificate Issued 2019-09-04 view
JXHL0600157 盐酸厄洛替尼片 erlotinib hydrochloride Tablet Chemical Drugs(3.4) Import Drug Application 2006-05-30 上海罗氏制药有限公司(北京办事处) Shanghai Roche Pharmaceuticals Ltd Beijing;Roche Pharma (Schweiz) Ltd Certificate Issued 2008-05-21 view
J0401641 利妥昔单抗注射液 rituximab Injection Biological Products Import Drug Application 2004-09-09 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Issued 2005-07-21 view
JXHL0600034 卡培他滨片 capecitabine Tablet Chemical Drugs Import Drug Application 2006-02-13 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing;F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2007-04-30 view
A20000105 复合维生素 Other Chemical Drugs New Drug Application 2000-10-25 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Approval Completed-Pending Certificated 2002-08-07 view
J0400540 奥利司他微丸(制剂中间体) orlistat Pellet Chemical Drugs Supplementary Application 2004-04-12 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Issued 2004-12-09 view
J0300894 卡维地洛片 carvedilol Tablet Chemical Drugs Supplementary Application 2003-07-07 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Approval Completed-Pending Certificated 2003-11-21 view
J0301409 甲磺酸沙奎那韦胶囊 saquinavir mesylate Capsule Chemical Drugs License Renew 2003-09-28 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Approval Completed-Pending Certificated 2004-05-09 view
J0301891 卡维地洛片 carvedilol Tablet Chemical Drugs Supplementary Application 2003-12-31 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Issued 2004-11-11 view
J0301552 伊班膦酸片 ibandronate sodium Tablet Chemical Drugs(3.1) Import Drug Application 2004-09-13 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Issued 2005-01-31 view
J0300185 卡培他滨片 capecitabine Tablet Chemical Drugs License Renew 2003-03-11 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Approval Completed-Pending Certificated 2003-08-14 view
J0400886 托拉塞米片 torasemide Tablet Chemical Drugs Supplementary Application 2004-05-31 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Issued 2005-02-03 view
J0401188 注射用重组人红细胞生成素-beta Lyophilized Biological Products License Renew 2004-07-07 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Issued 2009-09-10 view
JXHL0500226 多巴丝肼控释胶囊 benserazide hydrochloride;levodopa Capsules, extended release Chemical Drugs(3.2) Import Drug Application 2005-11-09 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing;Roche Pharma (Schweiz) Ltd Certificate Issued 2007-07-05 view
J0301512 聚乙二醇干扰素alfa-2a注射液 peginterferon alfa-2a Injection Biological Products Supplementary Application 2003-10-26 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Approval Completed-Pending Certificated 2004-02-18 view
J0301725 吗替麦考酚酯片 mycophenolate mofetil Tablet Chemical Drugs Supplementary Application 2004-06-16 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Issued 2004-12-15 view
JXHL0500052 盐酸缬更昔洛韦片 valganciclovir hydrochloride Tablet Chemical Drugs(3.1) Import Drug Application 2005-03-28 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing;F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2005-11-01 view