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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHB2050415 磺达肝癸钠注射液 fondaparinux sodium Injection Chemical Drugs Supplementary Application 2020-07-15 扬子江药业集团江苏紫龙药业有限公司,信泰制药(苏州)有限公司 Certificate Issued 2021-11-19 view
CYHB2040019 注射用米卡芬净钠 micafungin sodium Lyophilized Chemical Drugs Supplementary Application 2020-05-10 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd In Review 2020-05-09 view
CYHS2000199 磷酸奥司他韦干混悬剂 oseltamivir phosphate Suspension Chemical Drugs(3) Generic Drug 2020-03-21 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd In Review 2020-03-20 view
CYHS1900819 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs(4) Generic Drug 2019-12-05 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2021-07-30 view
CYHS1900527 注射用伏立康唑 voriconazole Lyophilized Chemical Drugs(4) Generic Drug 2019-07-31 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd In Review 2019-07-29 view
CYHB1902032 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2019-04-24 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2019-07-02 view
CYHS1900071 阿卡波糖片 acarbose Tablet Chemical Drugs(4) Generic Drug 2019-01-22 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2021-04-02 view
CYHS1700655 恩替卡韦片 entecavir Tablet Chemical Drugs(4) Generic Drug 2018-05-17 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2019-07-02 view
CYHS1400365 盐酸帕罗西汀肠溶缓释片 paroxetine hydrochloride Tablet, extended release Chemical Drugs(6) Generic Drug 2014-11-27 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2016-09-11 view
CYHS1400364 盐酸帕罗西汀肠溶缓释片 paroxetine hydrochloride Tablet, extended release Chemical Drugs(6) Generic Drug 2014-11-27 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2016-09-11 view
CYHS1400363 盐酸帕罗西汀肠溶缓释片 paroxetine hydrochloride Tablet, extended release Chemical Drugs(6) Generic Drug 2014-11-27 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2016-09-11 view
CYHS1400362 盐酸帕罗西汀 paroxetine hydrochloride Active ingredient Chemical Drugs(6) Generic Drug 2014-11-27 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd In Review 2014-11-25 view
CYHS1400469 注射用米卡芬净钠 micafungin sodium Lyophilized Chemical Drugs(6) Generic Drug 2014-07-17 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2020-04-14 view
CXHS1400129 米卡芬净钠 micafungin sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2014-07-14 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd In Review 2014-07-11 view
CXHL1400627 磺达肝癸钠 fondaparinux sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2014-07-14 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd In Review 2014-07-11 view
CYHS1400656 磺达肝癸钠注射液 fondaparinux sodium Injection Chemical Drugs(6) Generic Drug 2014-07-14 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2019-11-28 view
CYHS1301195 埃索美拉唑钠 esomeprazole sodium Active ingredient Chemical Drugs(6) Generic Drug 2014-04-30 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd In Review 2014-04-29 view
CYHS1301196 注射用埃索美拉唑钠 esomeprazole sodium Lyophilized Chemical Drugs(6) Generic Drug 2014-04-30 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2019-12-02 view
CYHS1301632 注射用醋酸卡泊芬净 caspofungin acetate Lyophilized Chemical Drugs(6) Generic Drug 2014-03-06 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2020-01-14 view
CYHS1301631 注射用醋酸卡泊芬净 caspofungin acetate Lyophilized Chemical Drugs(6) Generic Drug 2014-03-06 信泰制药(苏州)有限公司 BrightGene Pharmaceutical Co Ltd Certificate Issued 2020-01-14 view