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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYZZ2500011 香松通络油 Liniment Chinese Herbal Medicine License Renew 2025-06-12 Ling Nam Medicine Factory(HK)Ltd view
JYZZ2500010 香松通络油 Liniment Chinese Herbal Medicine License Renew 2025-06-12 Ling Nam Medicine Factory(HK)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
JYSZ2500016 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
JYSZ2500015 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
JYSZ2500014 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
JYSB2500131 乙型肝炎病毒 丙型肝炎病毒 人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) Diagnostic reagent IVD Supplementary Application 2025-06-12 Roche Molecular Systems Inc view
JYHZ2500115 苯磺酸氨氯地平片 amlodipine besylate Tablet Chemical Drugs License Renew 2025-06-12 Novartis Pharmaceutical Manufacturing LLC;Lek Pharmaceuticals DD view
JYHB2500316 玛巴洛沙韦片 baloxavir marboxil Tablet Chemical Drugs(5.1) Supplementary Application 2025-06-12 Shionogi Pharma Co Ltd;Roche Pharma (Schweiz) AG view
JYHB2500315 玛巴洛沙韦片 baloxavir marboxil Tablet Chemical Drugs(5.1) Supplementary Application 2025-06-12 Roche Pharma (Schweiz) AG view
JYHB2500314 复方肝素钠尿囊素凝胶 Gel Chemical Drugs Supplementary Application 2025-06-12 Merz Pharmaceuticals GmbH;Merz Pharma Gmbh & Co KGaA view
JYHB2500313 复方肝素钠尿囊素凝胶 Gel Chemical Drugs Supplementary Application 2025-06-12 Merz Pharmaceuticals GmbH;Merz Pharma Gmbh & Co KGaA view
JYHB2500312 普拉替尼胶囊 pralsetinib Capsule Chemical Drugs(1) Supplementary Application 2025-06-12 Catalent Cts LLC;Rigel Pharmaceuticals Inc view
JYHB2500311 布地奈德福莫特罗吸入气雾剂(I) Budesonide;Formoterol Inhalation Chemical Drugs(5.2) Supplementary Application 2025-06-10 Kindeva Drug Delivery;Mylan Pharmaceuticals Inc view
JYHB2500310 布地奈德福莫特罗吸入气雾剂(II) budesonide;formoterol fumarate Inhalation Chemical Drugs(5.2) Supplementary Application 2025-06-10 Kindeva Drug Delivery;Mylan Pharmaceuticals Inc view
JYHB2500309 达罗他胺片 darolutamide Tablet Chemical Drugs Supplementary Application 2025-06-10 Orion Corporation Orion Pharma Espoo Plant;Bayer Healthcare Pharmaceuticals Inc view
JYHB2500308 地屈孕酮片 dydrogesterone Tablet Chemical Drugs Supplementary Application 2025-06-10 Abbott BV;Abbott Biologicals BV 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
JXSS2500095 帕博利珠单抗注射液(皮下注射) pembrolizumab Injection Biological Products(2.1) Import Drug Application 2025-06-12 BSP Pharmaceuticals SpA;Merck Sharp & Dohme BV;MSD R&D (China) Co Ltd view
JXSS2500094 帕博利珠单抗注射液(皮下注射) pembrolizumab Injection Biological Products(2.1) Import Drug Application 2025-06-12 BSP Pharmaceuticals SpA;Merck Sharp & Dohme BV;MSD R&D (China) Co Ltd view