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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB2500107 BNT323 BNT-323 Biological Products(1) Supplementary Application 2025-06-25 BioNTech (Shanghai) Pharmaceuticals Co Ltd;Yingen Biopharmaceutical (Suzhou) Co Ltd view
JTS2500047 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Disposable Import Drug Application 2025-06-25 Kyowa Hakko Kirin China Pharmaceutical Co Ltd;Terumo Corporation Kofu Factory;Kyowa Hakko Kirin Co Ltd view
CYSB2500138 重组人凝血酶 thrombin alfa Liniment Biological Products(3.2) Supplementary Application 2025-06-25 Suzhou Zelgen Biopharmaceuticals Co Ltd 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
JYSB2500149 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2025-06-25 Genentech Inc;Roche Pharma (Schweiz) AG view
CYHS2502270 地屈孕酮片 dydrogesterone Tablet Chemical Drugs(4) Generic Drug 2025-06-25 Bei Jing Scrianen Pharmaceutical Co Ltd view
CXHL2500618 AXT-1003胶囊 AXT-1003 Capsule Chemical Drugs(1) New Drug Application 2025-06-25 AXTER THERAPEUTICS (BEIJING) Co Ltd view
CYZB2501272 补血润泽胶囊 Capsule Chinese Herbal Medicine(其他情形) Supplementary Application 2025-06-25 Hainan Yangshengtang Phaymaceution Co Ltd view
CYHS2502274 乙酰半胱氨酸注射液 acetylcysteine Injection Chemical Drugs(4) Generic Drug 2025-06-25 Jilin Aodong Pharmaceutical Industry Group Yanji Co Ltd view
CYZB2501277 宁神丸 Pellet Chinese Herbal Medicine Supplementary Application 2025-06-25 Chongqing Hilan Pharmaceutical Co Ltd view
CYHB2501245 盐酸昂丹司琼片 ondansetron hydrochloride Tablet Chemical Drugs(3) Supplementary Application 2025-06-25 Hongguan Bio-pharma Co Ltd;Ningbo Menovo TianKang 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
JYHZ2500123 阿奇霉素片 azithromycin Tablet Chemical Drugs(5.1) License Renew 2025-06-25 Pliva Croatia Ltd;Teva Pharmaceutical Information Consulting (Shanghai) Co Ltd view
CYHB2501244 盐酸昂丹司琼片 ondansetron hydrochloride Tablet Chemical Drugs(3) Supplementary Application 2025-06-25 Hongguan Bio-pharma Co Ltd;Ningbo Menovo TianKang Pharmaceutical Co Ltd view
JYHZ2500121 聚多卡醇注射液 polidocanol Injection Chemical Drugs License Renew 2025-06-25 Chemische Fabrik Kreussler & Co GmbH;Siegfried Hameln GmbH view
CYHS2502269 铝碳酸镁咀嚼片 hydrotalcite Tablet Chemical Drugs(4) Generic Drug 2025-06-25 Shanghai Johnson & Johnson Pharmaceuticals Ltd view
CYZB2501278 复方桔梗止咳片 Tablet Chinese Herbal Medicine(原9) Supplementary Application 2025-06-25 Henan Fusen Pharmaceutical Co Ltd view
CYHB2501246 氯化钾口服溶液 Potassium chloride Oral solution Chemical Drugs(3) Supplementary Application 2025-06-25 Zhejiang Gaozhi Pharmaceutical Technology Co Ltd;Zhejiang Conba Pharmaceutical Co Ltd view
JYHZ2500120 瑞戈非尼片 regorafenib Tablet Chemical Drugs License Renew 2025-06-25 Bayer AG view
CYZB2501275 五味沙棘散 Powder Chinese Herbal Medicine Supplementary Application 2025-06-25 INNER MONGOLIA Mongolian MEDICINE Co Ltd view