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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHB2501169 西甲硅油乳剂 simeticone Oral emulsion Chemical Drugs(4) Supplementary Application 2025-06-12 Hunan Jiudian Pharmaceutical Co Ltd;Shanxi Ante Bio-pharmaceutical Co Ltd view
JXSS2500072 帕博利珠单抗注射液(皮下注射) pembrolizumab Injection Biological Products(2.1) Import Drug Application 2025-06-07 BSP Pharmaceuticals SpA;Merck Sharp & Dohme BV;MSD R&D (China) Co Ltd view
CYHS2502069 乙酰半胱氨酸注射液 acetylcysteine Injection Chemical Drugs(4) Generic Drug 2025-06-12 Hainan Hualon Pharmaceutical Co Ltd;Zhejiang Cdmo Pharmaceutical Co Ltd view
CXSL2500476 注射用SHR-A2009 SHR-A2009 Lyophilized Biological Products(1) New Drug Application 2025-06-12 Suzhou Suncadia Biopharmaceuticals Co Ltd view
CYHB2550213 醋酸地塞米松片 dexamethasone acetate Tablet Chemical Drugs Supplementary Application 2025-06-10 Tianjin Lisheng Pharmaceutical Co Ltd view
JXHB2500071 LY3819469注射液 Lepodisiran Sodium Injection Chemical Drugs(1) Supplementary Application 2025-06-12 Vetter Development Services USA Inc;Eli Lilly & Company view
CYHS2502060 比拉斯汀口服溶液 bilastine Oral solution Chemical Drugs(3) Generic Drug 2025-06-11 Nanjing Huanglong Biotechnology Co Ltd;Zhihe (Shandong) Da Pharmaceutical Co Ltd view
CYHB2501145 曲安奈德益康唑乳膏 Econazole Nitrate;Triamcinolone acetonide Cream Chemical Drugs Supplementary Application 2025-06-07 Sinomune Pharmaceutical Co Ltd view
CYZB2501142 清热解毒口服液 Oral solution Chinese Herbal Medicine Supplementary Application 2025-06-12 Huaihua Zhenghao Pharmaceutical Co Ltd;KP Pharmacy Co Ltd view
CYHB2501162 卡贝缩宫素注射液 carbetocin Injection Chemical Drugs(4) Supplementary Application 2025-06-10 Hainan General Sanyang Pharmaceutical Co Ltd;Sichuan Meida Kangjiale Pharmaceutical Co Ltd view
CYHS2502030 蛋白琥珀酸铁口服溶液 Iron Proteinsuccinylate Oral solution Chemical Drugs(4) Generic Drug 2025-06-09 Henan Taifeng Biotechnology Co Ltd view
JYSZ2500017 注射用重组人凝血因子VIII Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products License Renew 2025-06-12 Novo Nordisk (China) Pharmaceuticals Co Ltd;Novo Nordisk A/S view
CYHS2502110 多索茶碱糖浆 doxofylline Oral solution Chemical Drugs(3) Generic Drug 2025-06-12 Zhejiang Cdmo Pharmaceutical Co Ltd view
CYHS2502050 沙库巴曲缬沙坦钠片 sacubitril;valsartan Tablet Chemical Drugs(4) Generic Drug 2025-06-11 Shijiazhuang NO4 Pharmaceutical Co Ltd view
CYHB2550219 氯化钾注射液 Potassium chloride Injection Chemical Drugs Supplementary Application 2025-06-12 Hubei Tiansheng Pharmaceutical Co Ltd view
JYHB2500307 ω-3脂肪酸乙酯90软胶囊 Soft capsules Chemical Drugs(5.1) Supplementary Application 2025-06-07 Patheon Softgels BV;Abbott Laboratories Ltd view
CYSB2500133 司普奇拜单抗注射液 stapokibart Injection Biological Products Supplementary Application 2025-06-11 Chengdu Kangnuoxing Biopharma Inc view
CYHS2502118 乙酰半胱氨酸注射液 acetylcysteine Injection Chemical Drugs(4) Generic Drug 2025-06-12 Zhejiang Bio-diamond Pharmaceutical Technology Co Ltd;Zhejiang Cdmo Pharmaceutical Co Ltd view
CYHS2502075 布瑞哌唑片 brexpiprazole Tablet Chemical Drugs(4) Generic Drug 2025-06-12 Hunan Xiangzhong Pharmaceutical Co Ltd view
CYHL2500108 环孢素滴眼液(Ⅱ) ciclosporin Eye drops Chemical Drugs(3) Generic Drug 2025-06-10 Lunan BETTER Pharmaceutical Co Ltd view