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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2500356 艾美赛珠单抗注射液 emicizumab Injection Biological Products(3.3) New Drug Application 2025-05-08 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CXSL2500357 艾美赛珠单抗注射液 emicizumab Injection Biological Products(3.3) New Drug Application 2025-05-08 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2501531 佩玛贝特片 pemafibrate Tablet Chemical Drugs(4) Generic Drug 2025-04-23 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2501515 左卡尼汀咀嚼片 levocarnitine Tablet Chemical Drugs(3) Generic Drug 2025-04-22 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2501342 磷苯妥英钠注射用浓溶液 fosphenytoin sodium Injection Chemical Drugs(3) Generic Drug 2025-04-09 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2501341 磷苯妥英钠注射用浓溶液 fosphenytoin sodium Injection Chemical Drugs(3) Generic Drug 2025-04-09 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2501234 亚甲蓝肠溶缓释片 methylthioninium chloride Tablet, extended release Chemical Drugs(4) Generic Drug 2025-04-01 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CXSL2500197 NTB003注射液 NTB-003 Injection Biological Products(1) New Drug Application 2025-03-04 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2500851 蔗糖羟基氧化铁咀嚼片 starch;Sucroferric Oxyhydroxide;sucrose Tablet Chemical Drugs(4) Generic Drug 2025-02-26 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHB2500225 西格列汀二甲双胍缓释片 metformin hydrochloride;sitagliptin phosphate Tablet, extended release Chemical Drugs(3) Supplementary Application 2025-01-27 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2500157 八氟丙烷脂质微球注射液 Injection Chemical Drugs(4) Generic Drug 2025-01-09 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2404454 甲磺酸沙非胺片 safinamide mesylate Tablet Chemical Drugs(4) Generic Drug 2024-12-21 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2404455 甲磺酸沙非胺片 safinamide mesylate Tablet Chemical Drugs(4) Generic Drug 2024-12-21 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2403947 阿帕他胺片 apalutamide Tablet Chemical Drugs(4) Generic Drug 2024-11-16 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CXHL2401199 NTQ5082胶囊 NTQ-5082 Capsule Chemical Drugs(1) New Drug Application 2024-11-08 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CXHL2401198 NTQ5082胶囊 NTQ-5082 Capsule Chemical Drugs(1) New Drug Application 2024-11-08 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHB2401625 马来酸阿伐曲泊帕片 avatrombopag maleate Tablet Chemical Drugs(4) Supplementary Application 2024-10-11 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHS2403274 瑞舒伐他汀依折麦布片(I) ezetimibe;rosuvastatin calcium Tablet Chemical Drugs(4) Generic Drug 2024-09-27 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHL2400187 琥珀酰明胶注射液 Succinylated Gelatin Injection Chemical Drugs(4) Generic Drug 2024-09-14 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHL2400185 琥珀酰明胶电解质醋酸钠注射液 Multiple Electrolytes;Sodium Acetate;Succinylated Gelatin Injection Chemical Drugs(4) Generic Drug 2024-09-11 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view