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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
JXHL1100300 TMC207 bedaquiline fumarate Active ingredient Chemical Drugs Import Drug Application 2011-09-01 Tibotec BVBA Tibotec Bvba Certificate Issued 2015-03-04 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
JTH2300218 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2023-09-13 view
JTH2300186 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2023-07-26 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
JTH2200248 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2022-12-27 view
JTH2200207 富马酸贝达喹啉 bedaquiline fumarate Active ingredient Chemical Drugs Disposable Import Drug Application 2022-10-27 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
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
JYHB2000835 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2020-06-15 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Filed 2020-06-19 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
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
JYHB2200608 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2022-11-08 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
JYHB2400511 富马酸贝达喹啉片 bedaquiline fumarate Tablet Chemical Drugs Supplementary Application 2024-09-28 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
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
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