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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1400077 注射用重组抗人表皮生长因子受体2(HER2)单抗(曲妥珠单抗) trastuzumab Lyophilized Biological Products(2) New Drug Application 2014-09-12 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2016-07-21 view
JYSB1200278 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2012-12-07 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2013-07-18 view
JYSB0500021 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2005-05-12 Certificate Issued 2005-09-23 view
CYSB2400292 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) Supplementary Application 2024-11-09 Anhui Anke Biotechnology (Group) Co Ltd view
CYSB2000306 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2020-11-25 上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd In Review 2022-01-27 view
JYSF1800009 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2018-06-21 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2018-07-13 view
JYSB1400069 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2014-06-10 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2014-11-06 view
JYSB0900088 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2009-06-02 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2009-11-16 view
CYSB2101216 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2021-10-09 Shanghai Henlius Biopharmaceutical Co Ltd view
JXSL1900066 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Import Drug Application 2019-08-01 美信美达医药信息咨询(北京)有限责任公司 Meixin Meida Medical Information Consulting (Beijing) Co Ltd In Review 2019-07-31 view
JYSB1500163 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2015-06-05 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2015-09-08 view
JXSL1000028 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Import Drug Application 2010-07-15 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2012-08-14 view
JYSB2300117 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2023-07-12 view
BS20020011 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Import Drug Application 2002-09-25 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-05-08 view
CYSB2400136 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) Supplementary Application 2024-05-25 Anhui Anke Biotechnology (Group) Co Ltd view
JYSB2000360 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.1) Supplementary Application 2020-08-04 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Filed 2020-08-17 view
JYSB1700172 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2017-09-27 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2018-05-30 view
JYSB1300191 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2013-08-09 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2014-11-25 view
JXSL0700010 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(7) Import Drug Application 2007-04-20 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2009-01-08 view
CXSS2101019 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) New Drug Application 2021-08-05 Anhui Anke Biotechnology (Group) Co Ltd view