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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS2501783 吡仑帕奈口服混悬液 Perampanel Suspension Chemical Drugs(4) Generic Drug 2025-05-16 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500949 注射用头孢唑林钠 cefazolin sodium Lyophilized Chemical Drugs Supplementary Application 2025-05-12 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500950 注射用头孢唑林钠 cefazolin sodium Lyophilized Chemical Drugs Supplementary Application 2025-05-12 Hunan Kelun Pharmaceutical Co Ltd view
CXHL2500449 KLA318-2纳米晶注射液 Chemical Drugs(2.2) New Drug Application 2025-05-09 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500919 醋酸加尼瑞克注射液 ganirelix acetate Injection Chemical Drugs(4) Supplementary Application 2025-05-07 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500908 盐酸罗哌卡因注射液 ropivacaine hydrochloride Injection Chemical Drugs(4) Supplementary Application 2025-05-01 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500907 盐酸罗哌卡因注射液 ropivacaine hydrochloride Injection Chemical Drugs(4) Supplementary Application 2025-05-01 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2501610 佩玛贝特片 pemafibrate Tablet Chemical Drugs(4) Generic Drug 2025-04-29 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500799 奥拉帕利片 olaparib Tablet Chemical Drugs(4) Supplementary Application 2025-04-23 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500800 奥拉帕利片 olaparib Tablet Chemical Drugs(4) Supplementary Application 2025-04-23 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2501373 注射用头孢哌酮钠舒巴坦钠/氯化钠注射液 cefoperazone sodium;sulbactam sodium Injection Chemical Drugs(4) Generic Drug 2025-04-10 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2501374 注射用头孢哌酮钠舒巴坦钠/氯化钠注射液 cefoperazone sodium;sulbactam sodium Injection Chemical Drugs(4) Generic Drug 2025-04-10 Hunan Kelun Pharmaceutical Co Ltd view
CYHB2500643 甲磺酸仑伐替尼胶囊 Lenvatinib mesylate Capsule Chemical Drugs Supplementary Application 2025-03-28 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2501158 比拉斯汀口服溶液 bilastine Oral solution Chemical Drugs(3) Generic Drug 2025-03-25 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2500402 苯磺酸氨氯地平口服溶液 amlodipine besylate Oral solution Chemical Drugs(3) Generic Drug 2025-01-22 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2500401 苯磺酸氨氯地平口服溶液 amlodipine besylate Oral solution Chemical Drugs(3) Generic Drug 2025-01-22 Hunan Kelun Pharmaceutical Co Ltd view
CXHL2500046 注射用KLA578-1 Chemical Drugs(2.2) New Drug Application 2025-01-09 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2404530 伊布替尼片 ibrutinib Tablet Chemical Drugs(3) Generic Drug 2024-12-26 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2404500 复方电解质注射液(V) Injection Chemical Drugs(3) Generic Drug 2024-12-25 Hunan Kelun Pharmaceutical Co Ltd view
CYHS2404461 注射用硫酸艾沙康唑 isavuconazonium sulfate Lyophilized Chemical Drugs(4) Generic Drug 2024-12-21 Hunan Kelun Pharmaceutical Co Ltd view