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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHB2501238 布美他尼注射液 bumetanide Injection Chemical Drugs(3) Supplementary Application 2025-06-24 Shanxi Nuocheng Pharmaceutical Co Ltd;Shandong Xinhua Pharmaceutical Company Limited view
CYZB2501287 五酯滴丸 Pellet Chinese Herbal Medicine(原9) Supplementary Application 2025-06-27 Sichuan Hezheng Pharmaceutical Co Ltd view
JYHB2500334 诺西那生钠注射液 nusinersen sodium Injection Chemical Drugs(5.1) Supplementary Application 2025-06-24 Patheon Italia SpA;Biogen Netherlands BV view
CYHS2502320 乙酰半胱氨酸注射液 acetylcysteine Injection Chemical Drugs(4) Generic Drug 2025-06-30 Beijing Continent Pharmaceuticals Co Ltd;Zhejiang Cdmo Pharmaceutical Co Ltd view
CYHB2501249 盐酸吗啉胍片 moroxydine hydrochloride Tablet Chemical Drugs Supplementary Application 2025-06-26 Heilongjiang Haxing Pharmaceutical Co Ltd;Heilongjiang Jun'an Pharmaceutical Group Hongxiang Pharmaceutical Co Ltd view
CXHL2500604 JMKX003002片 JMKX-003002 Tablet Chemical Drugs(1) New Drug Application 2025-06-23 Zhejiang Hangyu Pharmaceutical Co Ltd view
CYHB2501261 阿法骨化醇软胶囊 alfacalcidol Soft capsules Chemical Drugs Supplementary Application 2025-06-27 Qingdao Chia Tai Haier Pharmaceutical Co Ltd view
JXSL2500112 U3-1402 patritumab deruxtecan Injection Biological Products(1) Import Drug Application 2025-06-24 First Pharmaceutical (China) Co Ltd;Daiichi Sankyo Co Ltd view
JXSL2500113 VAY736注射液 ianalumab Injection Biological Products(1) Import Drug Application 2025-06-28 China Novartis Institutes For Biomedical Research Co Ltd;Novartis Pharma Schweiz AG view
CYHB2501273 西咪替丁片 cimetidine Tablet Chemical Drugs Supplementary Application 2025-06-28 Heilongjiang Haxing Pharmaceutical Co Ltd;Heilongjiang Jun'an Pharmaceutical Group Hongxiang Pharmaceutical Co Ltd view
CYHS2502279 盐酸西替利嗪滴剂 cetirizine hydrochloride Drops Chemical Drugs(4) Generic Drug 2025-06-26 Jiangsu Tasly DIYI Pharmaceutical Co Ltd view
CXHL2500606 JMKX003002片 JMKX-003002 Tablet Chemical Drugs(1) New Drug Application 2025-06-23 Zhejiang Hangyu Pharmaceutical Co Ltd view
CXSL2500510 ALMB-0166注射液 ALMB-0166 Injection Biological Products(1) New Drug Application 2025-06-24 Shanghai Enlemai Biotechnology Co Ltd view
JYHZ2500124 盐酸左卡巴斯汀鼻喷雾剂 levocabastine hydrochloride Spray Chemical Drugs License Renew 2025-06-27 Shanghai Johnson & Johnson Pharmaceuticals Ltd;Johnson & Johnson Innovative Medicine;Johnson & Johnson Consumer NV view
CYHB2501275 注射用盐酸头孢吡肟 cefepime hydrochloride Lyophilized Chemical Drugs Supplementary Application 2025-06-28 Guangzhou Baiyunshan Tianxin Pharmaceutical Co Ltd view
JYSB2500150 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2025-06-25 Patheon Italia SpA;Recordati Netherlands BV view
CYZB2501264 复方片仔癀软膏 Ointment Chinese Herbal Medicine Supplementary Application 2025-06-24 Zhangzhou Pientzehuang Pharmaceutical Co Ltd view
JTH2500107 精氨酸培哚普利片 perindopril arginine Tablet Chemical Drugs Disposable Import Drug Application 2025-06-27 Les Laboratoires Servier Industrie;Shanghai Bozhiyan New Drug Research Co Ltd view
JYHZ2500129 米曲菌胰酶片 Tablet Chemical Drugs License Renew 2025-06-28 Nordmark Arzneimittel GmbH & Co KG;Bridging Pharma GmbH view
JYSB2500148 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2025-06-25 Genentech Inc;Roche Pharma (Schweiz) AG view