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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS2000853 奥贝胆酸片 obeticholic acid Tablet Chemical Drugs(3) Generic Drug 2020-12-09 江苏恒瑞医药股份有限公司 Jiangsu Hengrui Pharmaceuticals Co Ltd Certificate Issued 2021-10-29 view
CYHS2000852 奥贝胆酸片 obeticholic acid Tablet Chemical Drugs(3) Generic Drug 2020-12-09 江苏恒瑞医药股份有限公司 Jiangsu Hengrui Pharmaceuticals Co Ltd Certificate Issued 2021-10-29 view
CYHS2000434 熊去氧胆酸胶囊 ursodeoxycholic acid Capsule Chemical Drugs(4) Generic Drug 2020-06-29 安士制药(中山)有限公司 Anshi Pharmaceutical (Zhongshan) Inc Certificate Issued 2021-09-13 view
JYHZ2000144 牛磺熊去氧胆酸胶囊 tauroursodeoxycholic acid Capsule Chemical Drugs License Renew 2020-06-13 意大利贝斯迪大药厂 Bruschettini Srl;Doppel Farmaceutical Srl Certificate Issued 2021-03-04 view
JTH2100038 熊去氧胆酸口服混悬液 ursodeoxycholic acid Suspension Chemical Drugs Disposable Import Drug Application 2021-02-05 Vifor SA, Zweigniederlassung Medichemie Ettingen Corden Pharma Fribourg AG Zweigniederlassung Ettingen;Dr Falk Pharma GmbH;Shenzhen Kangzhe Biotechnology Co Ltd Certificate Issued 2021-03-02 view
CYHB2150125 熊去氧胆酸片 ursodeoxycholic acid Tablet Chemical Drugs Supplementary Application 2021-02-27 武汉普元药业有限责任公司 Wuhan Puyuan Pharmaceutical Co Ltd In Review 2021-02-26 view
JXHL2100023 熊去氧胆酸口服混悬液 ursodeoxycholic acid Suspension Chemical Drugs(5.1) Import Drug Application 2021-01-23 深圳市康哲生物科技有限公司 Shenzhen Kangzhe Biotechnology Co Ltd;Dr Falk Pharma GmbH In Review 2021-01-22 view
CYHS2000728 熊去氧胆酸胶囊 ursodeoxycholic acid Capsule Chemical Drugs(4) Generic Drug 2020-10-17 上海宣泰医药科技股份有限公司 Sinotherapeutics Inc;Haimen PHARMA INC In Review 2020-10-16 view
JYHB2001420 熊去氧胆酸软胶囊 ursodeoxycholic acid Soft capsules Chemical Drugs Supplementary Application 2020-08-21 辽宁大熊制药有限公司 Liaoning Daewoong Pharmaceutical Co Ltd;Daewoong Pharmaceutical Co Ltd Filed 2020-09-02 view
JYHB2001421 熊去氧胆酸软胶囊 ursodeoxycholic acid Soft capsules Chemical Drugs Supplementary Application 2020-08-21 辽宁大熊制药有限公司 Liaoning Daewoong Pharmaceutical Co Ltd;Daewoong Pharmaceutical Co Ltd Filed 2020-09-02 view
CXHL2000423 奥贝胆酸镁片 Obeticholic acid Magnesium Tablet Chemical Drugs(2.1) New Drug Application 2020-09-01 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-08-31 view
CXHL2000425 奥贝胆酸镁片 Obeticholic acid Magnesium Tablet Chemical Drugs(2.1) New Drug Application 2020-09-01 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-08-31 view
CXHL2000424 奥贝胆酸镁片 Obeticholic acid Magnesium Tablet Chemical Drugs(2.1) New Drug Application 2020-09-01 苏州泽璟生物制药股份有限公司 Suzhou Zelgen Biopharmaceuticals Co Ltd In Review 2020-08-31 view
JTH2000204 牛磺熊去氧胆酸胶囊 tauroursodeoxycholic acid Capsule Chemical Drugs Disposable Import Drug Application 2020-07-23 DOPPEL FARMACEUTICI S.R.L. Doppel Farmaceutical Srl;Bruschettini Srl;Beijing Quanfu Kangjian Medicine Information Consulting Co Ltd Certificate Issued 2020-08-13 view
JYHB2001100 熊去氧胆酸胶囊 ursodeoxycholic acid Capsule Chemical Drugs Supplementary Application 2020-06-28 深圳市康哲药业有限公司 Shenzhen Kangzhe Pharmaceutical Co Ltd;Losan Pharma GmbH;Dr Falk Pharma GmbH Filed 2020-06-30 view
JYHZ1900339 熊去氧胆酸胶囊 ursodeoxycholic acid Capsule Chemical Drugs License Renew 2019-12-30 深圳市康哲药业有限公司 Shenzhen Kangzhe Pharmaceutical Co Ltd;Losan Pharma GmbH;Dr Falk Pharma GmbH Certificate Issued 2020-06-03 view
CYHS2000325 奥贝胆酸片 obeticholic acid Tablet Chemical Drugs(3) Generic Drug 2020-05-18 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd In Review 2020-05-15 view
JYHZ2000019 牛磺熊去氧胆酸胶囊 tauroursodeoxycholic acid Capsule Chemical Drugs License Renew 2020-02-22 意大利贝斯迪大药厂 Bruschettini Srl;Doppel Farmaceutical Srl Certificate Issued 2020-05-15 view
CYHS2000282 奥贝胆酸片 obeticholic acid Tablet Chemical Drugs(3) Generic Drug 2020-05-07 正大天晴药业集团股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd In Review 2020-05-06 view
CYHS2000283 奥贝胆酸片 obeticholic acid Tablet Chemical Drugs(3) Generic Drug 2020-05-07 正大天晴药业集团股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd In Review 2020-05-06 view