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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB2000051 罗沙司他胶囊 roxadustat Capsule Chemical Drugs Supplementary Application 2020-06-16 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2020-06-15 view
JXSL2100030 Pamrevlumab pamrevlumab Injection Biological Products(1) Import Drug Application 2021-02-23 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2021-02-22 view
CXHL1600143 可博美胶囊(FG-4592胶囊) roxadustat Capsule Chemical Drugs(1) New Drug Application 2016-07-14 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd Certificate Issued 2017-03-15 view
CYHB1901708 罗沙司他胶囊 roxadustat Capsule Chemical Drugs Supplementary Application 2019-04-11 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2019-04-10 view
CXHB2100007 罗沙司他胶囊 roxadustat Capsule Chemical Drugs(1) Supplementary Application 2021-01-19 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2022-01-19 view
CYHB1513117 可博美胶囊(FG-4592胶囊) roxadustat Capsule Chemical Drugs Supplementary Application 2016-02-16 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd Certificate Issued 2016-10-27 view
CYHB1706886 罗沙司他胶囊 roxadustat Capsule Chemical Drugs Supplementary Application 2017-12-25 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2017-12-22 view
JXSL2100020 Pamrevlumab pamrevlumab Injection Biological Products(1) Import Drug Application 2021-02-10 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2021-02-10 view
CXHL1600142 可博美胶囊(FG-4592胶囊) roxadustat Capsule Chemical Drugs(1) New Drug Application 2016-07-11 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd Certificate Issued 2017-03-15 view
CXHS1800013 罗沙司他胶囊 roxadustat Capsule Chemical Drugs(1) New Drug Application 2018-06-29 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd Certificate Issued 2019-08-23 view
CXHB2100008 罗沙司他胶囊 roxadustat Capsule Chemical Drugs(1) Supplementary Application 2021-01-19 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2022-01-19 view
CXHS1700018 罗沙司他 roxadustat Active ingredient Chemical Drugs(1) New Drug Application 2017-11-02 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2017-10-31 view
JXSL2000068 Pamrevlumab pamrevlumab Injection Biological Products Import Drug Application 2020-06-09 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2020-06-03 view
CYHB1513116 可博美(FG-4592) roxadustat Active ingredient Chemical Drugs Supplementary Application 2016-02-16 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd Certificate Issued 2016-10-27 view
CXHS1800014 罗沙司他胶囊 roxadustat Capsule Chemical Drugs(1) New Drug Application 2018-06-29 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd Certificate Issued 2019-08-23 view
JXSB2000031 Pamrevlumab pamrevlumab Injection Biological Products(1) Supplementary Application 2020-10-15 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2020-10-14 view
CXHL2100151 罗沙司他胶囊 roxadustat Capsule Chemical Drugs(2.4) New Drug Application 2021-03-02 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2021-03-01 view
CXHS1700019 罗沙司他胶囊 roxadustat Capsule Chemical Drugs(1) New Drug Application 2017-11-01 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd Certificate Issued 2018-12-21 view
JXSL2000069 Pamrevlumab pamrevlumab Injection Biological Products Import Drug Application 2020-06-04 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2020-06-03 view
CXHB2100021 罗沙司他胶囊 roxadustat Capsule Chemical Drugs(1) Supplementary Application 2021-01-28 珐博进(中国)医药技术开发有限公司 FibroGen (China) Medical Technology Development Co Ltd In Review 2021-01-27 view