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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS2502009 碳酸司维拉姆干混悬剂 sevelamer carbonate Suspension Chemical Drugs(3) Generic Drug 2025-06-06 Jiangxi Kerui Pharmaceutical Co Ltd;Shandong Bestcomm Pharmaceutical Company Limited view
CYZB2501108 柔肝解毒口服液 Oral solution Chinese Herbal Medicine Supplementary Application 2025-06-06 Sichuan QILI Pharmaceutical Co Ltd view
CYHS2502001 地拉罗司分散片 deferasirox Tablet Chemical Drugs(4) Generic Drug 2025-06-06 Hebei TIANCHENG Pharmaceutical Co Ltd view
CXSL2500455 注射用SHR-A1811 SHR-A1811 Lyophilized Biological Products(1) New Drug Application 2025-06-06 Suzhou Suncadia Biopharmaceuticals Co Ltd view
CYHS2502012 维生素K1注射液 phytomenadione Injection Chemical Drugs(3) Generic Drug 2025-06-06 Chengdu Easton Bio Pharmaceuticals Co Ltd view
CXSB2500086 重组抗CTLA-4全人单克隆抗体注射液 Injection Biological Products(3.3) Supplementary Application 2025-06-06 Shanghai Henlius Biologics Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd view
CYHS2502006 唑来膦酸注射液 zoledronic acid Injection Chemical Drugs(4) Generic Drug 2025-06-06 Guangdong Yi Xiang Pharmaceutical Co Ltd view
CYHB2501137 小儿氨酚黄那敏颗粒 chlorphenamine maleate;galculus Bovis;paracetamol Granule Chemical Drugs Supplementary Application 2025-06-06 Guizhou Shengshi Longfang Pharmaceutical Co Ltd;Guizhou Junzhitang Pharmaceutical Co Ltd view
JXHL2500127 镥(177Lu)vipivotide tetraxetan注射液 lutetium (177Lu) vipivotide tetraxetan Injection Chemical Drugs(2.4) Import Drug Application 2025-06-06 China Novartis Institutes For Biomedical Research Co Ltd;Novartis Pharma Schweiz AG view
CXHL2500538 QL-H118片 Chemical Drugs(1) New Drug Application 2025-06-06 Nanjing Qinling Medical Technology Co Ltd view
JXHL2500126 用于制备放射性药物镓(68Ga)gozetotide注射液的药盒 Diagnostic reagent Chemical Drugs(5.1) Import Drug Application 2025-06-06 China Novartis Institutes For Biomedical Research Co Ltd;Novartis Europharm Ltd view
JXHL2500125 TAR-210 erdafitinib Active ingredient Chemical Drugs(2.2;2.4) Import Drug Application 2025-06-06 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
CYZB2501109 普乐安片 Tablet Chinese Herbal Medicine Supplementary Application 2025-06-06 Gansu Hexi Pharmaceutical Co Ltd view
CYHS2502011 硝普钠注射液 Nitroprusside sodium Injection Chemical Drugs(3) Generic Drug 2025-06-06 HE BEI YI PIN Pharmaceutical Co Ltd view
CYHB2501140 帕米膦酸二钠注射液 pamidronate disodium Injection Chemical Drugs(3) Supplementary Application 2025-06-06 Chengdu Tiantai Mountain Pharmaceutical Co Ltd;Sichuan Jianlin Pharmaceutical Co Ltd view
CXSS2500060 重组抗IL-1β人源化单克隆抗体注射液 SSGJ-613 Injection Biological Products(1) New Drug Application 2025-06-06 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
JTH2500096 克林霉素磷酸酯过氧苯甲酰凝胶 benzoyl peroxide;clindamycin phosphate Gel Chemical Drugs Disposable Import Drug Application 2025-06-06 Glaxo Operations UK Ltd;Shanghai Bozhiyan New Drug Research Co Ltd;Glaxosmithkline Uk Ltd view
CYHB2501139 注射用氯唑西林钠 cloxacillin sodium Lyophilized Chemical Drugs Supplementary Application 2025-06-06 Hainan General Sanyang Pharmaceutical Co Ltd view
CXSL2500450 贝伐珠单抗注射液 bevacizumab Injection Biological Products(2.2) New Drug Application 2025-06-06 Suzhou Suncadia Biopharmaceuticals Co Ltd view
CYSB2500130 舒格利单抗注射液 Sugemalimab Injection Biological Products(1) Supplementary Application 2025-06-06 Wuxi Biologics Co Ltd;Pfizer Investment Co Ltd view