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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYZB2501771 胃康灵胶囊 Capsule Chinese Herbal Medicine Supplementary Application 2025-08-18 Jilin TIAN Yao Bencaotang Pharmaceutical Co Ltd;Tianyaozhong Pharmaceutical Technology (Hainan) Co Ltd view
CYSB2500186 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(原15) Supplementary Application 2025-08-18 Hualan Biological Engineering Inc view
CYHB2501639 维生素B6注射液 pyridoxinium chloride Injection Chemical Drugs(原6) Supplementary Application 2025-08-16 Hunan Er-Kang Pharmaceutical Co Ltd view
JYHZ2500188 注射用替加环素 tigecycline Lyophilized Chemical Drugs License Renew 2025-08-16 Pfizer Europe Ma Eeig;Wyeth Lederle Srl;Pfizer Investment Co Ltd view
CYHB2501638 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs Supplementary Application 2025-08-16 Hainan Aike Pharmaceutical Co Ltd view
JYHB2500430 去氧孕烯炔雌醇片 desogestrel;ethinylestradiol Tablet Chemical Drugs(5.2) Supplementary Application 2025-08-16 Gedeon Ricther Plc view
JYHB2500428 甲磺酸贝舒地尔片 BELUMOSUDIL MESYLATE Tablet Chemical Drugs(5.1) Supplementary Application 2025-08-16 Kadmon Pharmaceuticals LLC;UPM Pharmaceuticals Inc view
CYHS2503016 盐酸卡替洛尔滴眼液 carteolol hydrochloride Eye drops Chemical Drugs(3) Generic Drug 2025-08-16 Chengdu DIAO Jiuhong Pharmaceutical Factory;Zhejiang Shapuaisi Pharmaceutical Co Ltd view
CXSL2500709 注射用乙型脑炎溶瘤病毒 Lyophilized Biological Products(1) New Drug Application 2025-08-16 Sichuan Ankekang Biomedical Co Ltd view
CYHS2503009 联苯苄唑溶液 bifonazole Topical solution Chemical Drugs(3) Generic Drug 2025-08-16 Zhongshan Wanhan Pharmaceuticals Co Ltd view
CXHL2500857 HWH217片 Tablet Chemical Drugs(2.3) New Drug Application 2025-08-16 Hubei Bio-Pharmaceutical Industrial Technological Institute Inc view
CYHS2503001 盐酸曲唑酮缓释片 trazodone hydrochloride Tablet, extended release Chemical Drugs(4) Generic Drug 2025-08-16 Hefei Licheng Pharmaceutical Co Ltd view
JYHB2500427 苯甲酸阿格列汀片 alogliptin benzoate Tablet Chemical Drugs Supplementary Application 2025-08-16 Takeda Ireland Ltd;Teijin Pharma Ltd view
JXHB2500107 硫酸艾沙康唑胶囊 isavuconazonium sulfate Capsule Chemical Drugs(5.1) Supplementary Application 2025-08-16 Pfizer Australia Pty Ltd;SwissCo Services AG view
JYSB2500189 纳武利尤单抗注射液 nivolumab Injection Biological Products Supplementary Application 2025-08-16 Bristol-Myers Squibb Pharma Eeig view
CYHS2503006 盐酸多巴酚丁胺注射液 dobutamine hydrochloride Injection Chemical Drugs(3) Generic Drug 2025-08-16 Shijiazhuang NO4 Pharmaceutical Co Ltd view
JYHB2500426 苯甲酸阿格列汀片 alogliptin benzoate Tablet Chemical Drugs Supplementary Application 2025-08-16 Takeda Ireland Ltd;Teijin Pharma Ltd view
CXHL2500859 MAX-001胶囊 MAX-001 Capsule Chemical Drugs(1) New Drug Application 2025-08-16 Anyanda Pharmaceutical Technology (Guangzhou) Co Ltd view
CXSL2500708 注射用乙型脑炎溶瘤病毒 Lyophilized Biological Products(1) New Drug Application 2025-08-16 Sichuan Ankekang Biomedical Co Ltd view
JYHB2500429 盐酸芬戈莫德胶囊 fingolimod hydrochloride Capsule Chemical Drugs(5.1) Supplementary Application 2025-08-16 Novartis Pharmaceutical Manufacturing LLC;Novartis Pharma Stein AG;Novartis Pharma Schweiz AG view