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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHL2500160 氟[18F]代雌二醇注射液 Chemical Drugs(3) Generic Drug 2025-09-01 Jiangsu HUAYI Technology Co Ltd view
JYHZ2500197 醋酸阿比特龙片 abiraterone acetate Tablet Chemical Drugs(5.2) License Renew 2025-09-01 Drreddy′s (Beijing) Pharmaceutical Co Limited;Dr Reddy's Laboratories Ltd view
CYHB2501730 碳酸氢钠片 sodium bicarbonate Tablet Chemical Drugs Supplementary Application 2025-08-30 Shandong Jianbin Pharmaceutical Technology Co Ltd;Jinan Yongning Pharmaceutical Co Ltd view
JXSB2500104 Mim8 denecimig Injection Biological Products(1) Supplementary Application 2025-08-30 Novo Nordisk A/S view
CXSL2500751 9MW3811注射液 9MW-3811 Injection Biological Products(1) New Drug Application 2025-08-30 Mabwell (Shanghai) Bioscience Co Ltd view
CYHS2503203 注射用氯诺昔康 lornoxicam Lyophilized Chemical Drugs(4) Generic Drug 2025-08-30 Beijing Sihuan Kebao Pharmaceutical Co Ltd view
CYHS2503192 达格列净二甲双胍缓释片(I) dapagliflozin;metformin hydrochloride Tablet, extended release Chemical Drugs(4) Generic Drug 2025-08-30 Shijiazhuang Polee Pharmaceutical Co Ltd;Shaanxi Junkeli Pharmaceutical Technology Co Ltd view
JTS2500073 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Disposable Import Drug Application 2025-08-30 Qilu Pharmaceutical (Hainan) Co Ltd;Terumo Corporation Kofu Factory view
CYHS2503201 盐酸二甲双胍口服溶液 metformin hydrochloride Oral solution Chemical Drugs(3) Generic Drug 2025-08-30 Anhui Sihuan Kebao Pharmaceutical Co Ltd view
CYHS2503180 莫匹罗星软膏 mupirocin Ointment Chemical Drugs(4) Generic Drug 2025-08-30 Hangzhou Huadong Medicine Group Kangrun Pharmaceutical Co Ltd;Hangzhou Zhuyangxin Pharmaceutical Co Ltd view
CYHB2501732 盐酸小檗碱片 berberine hydrochloride Tablet Chemical Drugs Supplementary Application 2025-08-30 Shandong Jianbin Pharmaceutical Technology Co Ltd;Jinan Yongning Pharmaceutical Co Ltd view
CYHB2501737 富马酸伏诺拉生片 vonoprazan fumarate Tablet Chemical Drugs(4) Supplementary Application 2025-08-30 Shijiazhuang NO4 Pharmaceutical Co Ltd view
CYHB2501736 富马酸伏诺拉生片 vonoprazan fumarate Tablet Chemical Drugs(4) Supplementary Application 2025-08-30 Shijiazhuang NO4 Pharmaceutical Co Ltd view
CYZB2501892 十味消食散 Powder Chinese Herbal Medicine Supplementary Application 2025-08-30 Tibet Changdu Liming Medicineltd;Xizang Darya Dry Pharmaceutical Co Ltd view
JXHL2500249 [111In]In-FL-020注射液 Chemical Drugs(1) Import Drug Application 2025-08-30 view
CYHB2501724 葡萄糖注射液 glucose Injection Chemical Drugs Supplementary Application 2025-08-30 Sichuan Pacific Pharmaceutical Co Ltd view
CYHS2503190 对乙酰氨基酚缓释片 paracetamol Tablet, extended release Chemical Drugs(4) Generic Drug 2025-08-30 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
CYHB2501728 卡托普利片 Captopril Tablet Chemical Drugs Supplementary Application 2025-08-30 Shandong Jianbin Pharmaceutical Technology Co Ltd;Jinan Yongning Pharmaceutical Co Ltd view
CYZB2501886 健脑益气片 Tablet Chinese Herbal Medicine Supplementary Application 2025-08-30 Harbin Kangzeyuan Pharmaceutical Co Ltd;Harbin Sandong Pharmaceutical Co Ltd view
JXHB2500118 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2025-08-30 Janssen Research & Development LLC;Janssen-Cilag SpA view