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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB1500008 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2015-03-13 北京万生药业有限责任公司 Beijing Foyou Pharma Co Ltd Certificate Issued 2016-02-04 view
CXHL1400865 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs(3.1) New Drug Application 2014-08-15 北京万生药业有限责任公司 Beijing Foyou Pharma Co Ltd Certificate Issued 2015-12-15 view
CXHL1400866 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(3.1) New Drug Application 2014-08-15 北京万生药业有限责任公司 Beijing Foyou Pharma Co Ltd Certificate Issued 2015-12-15 view
CXHL1500686 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs(3.1) New Drug Application 2015-06-05 开原亨泰制药有限公司 PharmaResources(Kaiyuan) Co Ltd Certificate Issued 2016-08-12 view
CXHL1500687 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(3.1) New Drug Application 2015-06-05 开原亨泰制药有限公司 PharmaResources(Kaiyuan) Co Ltd Certificate Issued 2016-08-04 view
CXHL1501128 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs(3.1) New Drug Application 2015-08-03 瑞阳制药有限公司 Reyoung Pharmaceutical Co Ltd Certificate Issued 2016-02-19 view
CXHL1501129 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(3.1) New Drug Application 2015-08-03 瑞阳制药有限公司 Reyoung Pharmaceutical Co Ltd Certificate Issued 2016-02-19 view
CXHL1502220 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs(3.1) New Drug Application 2016-02-16 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2017-02-21 view
CXHL1502221 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(3.1) New Drug Application 2016-02-16 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2017-02-21 view
CYHB2400519 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(4) Supplementary Application 2024-04-22 Beijing Foyou Pharma Co Ltd view
CYHS2000373 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(4) Generic Drug 2020-06-02 北京福元医药股份有限公司 Beijing Foyou Pharma Co Ltd Certificate Issued 2021-12-15 view
CYHS2101946 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(4) Generic Drug 2021-11-03 Hainan Simcere Pharmaceutical Co Ltd view
CYHS2403134 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs(4) Generic Drug 2024-09-20 view
JTH2200207 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2022-10-27 view
JTH2200248 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2022-12-27 view
JTH2300186 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2023-07-26 view
JTH2300218 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2023-09-13 view
JXHL0800144 TMC 207 bedaquiline fumarate Active ingredient Chemical Drugs Import Drug Application 2008-05-05 Tibotec BVBA Tibotec Bvba Certificate Issued 2009-01-05 view
JXHL1100300 TMC207 bedaquiline fumarate Active ingredient Chemical Drugs Import Drug Application 2011-09-01 Tibotec BVBA Tibotec Bvba Certificate Issued 2015-03-04 view
JXHL1200174 TMC207 bedaquiline fumarate Active ingredient Chemical Drugs Import Drug Application 2012-06-08 Janssen Infectious Diseases BVBA Janssen Infectious Diseases Bvba Certificate Issued 2012-12-11 view