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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL1200354 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Import Drug Application 2012-11-08 Janssen Infectious Diseases BVBA Janssen Infectious Diseases Bvba Certificate Issued 2014-06-17 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
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
JXHS1400100 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Import Drug Application 2014-10-08 Janssen-Cilag International N.V. Janssen-Cilag International NV Certificate Issued 2016-12-01 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
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
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
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
JYHB1601638 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2016-12-19 Janssen-Cilag International N.V. Janssen-Cilag International NV Certificate Issued 2017-06-12 view
JYHB1700578 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2017-04-27 Janssen-Cilag International NV Janssen-Cilag International NV Certificate Issued 2019-05-21 view
JYHB1701122 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2017-08-29 Janssen-Cilag International NV Janssen-Cilag International NV Filed 2017-09-11 view
JYHB1701544 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2017-12-11 Janssen-Cilag International NV Janssen-Cilag International NV Certificate Issued 2018-01-19 view
JYHB1900692 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2019-06-13 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Certificate Issued 2020-02-05 view
JYHB1900914 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2019-07-31 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Certificate Issued 2020-07-29 view
JYHB1901004 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2019-08-22 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Certificate Issued 2019-11-27 view
JYHB2000188 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2020-02-29 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Filed 2020-03-05 view
JYHB2000430 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2020-04-17 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Certificate Issued 2020-07-28 view