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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2500485 洛奈利单抗注射液 Injection Biological Products(1) New Drug Application 2025-06-14 Shandong New Time Pharmaceutical Co Ltd view
CYHS2502089 卡左双多巴缓释片 carbidopa;levodopa Tablet, extended release Chemical Drugs(4) Generic Drug 2025-06-12 Shandong New Time Pharmaceutical Co Ltd view
CYHS2502090 卡左双多巴缓释片 carbidopa;levodopa Tablet, extended release Chemical Drugs(4) Generic Drug 2025-06-12 Shandong New Time Pharmaceutical Co Ltd view
CXSB2500088 司美格鲁肽注射液 semaglutide Injection Biological Products(3.3) Supplementary Application 2025-06-10 Shandong New Time Pharmaceutical Co Ltd view
CXSB2500081 F008 F-008 Injection Biological Products(1) Supplementary Application 2025-06-04 Shandong New Time Pharmaceutical Co Ltd view
CYHS2501883 利伐沙班口崩片 rivaroxaban Tablet Chemical Drugs(3) Generic Drug 2025-05-27 Shandong New Time Pharmaceutical Co Ltd view
CYHS2501884 利伐沙班口崩片 rivaroxaban Tablet Chemical Drugs(3) Generic Drug 2025-05-27 Shandong New Time Pharmaceutical Co Ltd view
CYHS2501735 硫辛酸片 Tablet Chemical Drugs(3) Generic Drug 2025-05-14 Shandong New Time Pharmaceutical Co Ltd view
CYHS2501467 注射用醋酸西曲瑞克 cetrorelix acetate Lyophilized Chemical Drugs(4) Generic Drug 2025-04-17 Shandong New Time Pharmaceutical Co Ltd view
CXHL2500384 LN2222 LN-2222 Active ingredient Chemical Drugs(2.2) New Drug Application 2025-04-12 Shandong New Time Pharmaceutical Co Ltd view
CXHL2500383 LN2222 LN-2222 Active ingredient Chemical Drugs(2.2) New Drug Application 2025-04-12 Shandong New Time Pharmaceutical Co Ltd view
CXSL2500287 LNF2102注射液 LNF-2102 Injection Biological Products(1) New Drug Application 2025-04-10 Shandong New Time Pharmaceutical Co Ltd view
CXSB2500044 注射用重组人源化抗BCMA/CD3双特异性抗体 Recombinant Humanized Anti-BCMA/CD3 Bis-specific Antibody Preparation Lyophilized Biological Products(1) Supplementary Application 2025-03-29 Shandong New Time Pharmaceutical Co Ltd view
CYHB2500599 甲磺酸仑伐替尼胶囊 Lenvatinib mesylate Capsule Chemical Drugs(4) Supplementary Application 2025-03-25 Shandong New Time Pharmaceutical Co Ltd view
CYHB2500538 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs Supplementary Application 2025-03-15 Shandong New Time Pharmaceutical Co Ltd view
CYHB2500537 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs Supplementary Application 2025-03-15 Shandong New Time Pharmaceutical Co Ltd view
CXSL2500199 注射用重组人源化抗BCMA/CD3双特异性抗体 Recombinant Humanized Anti-BCMA/CD3 Bis-specific Antibody Preparation Lyophilized Biological Products(1) New Drug Application 2025-03-05 Shandong New Time Pharmaceutical Co Ltd view
CYHB2500337 硫辛酸注射液 Injection Chemical Drugs Supplementary Application 2025-02-19 Shandong New Time Pharmaceutical Co Ltd view
CYHB2500249 沙库巴曲缬沙坦钠片 sacubitril;valsartan Tablet Chemical Drugs(4) Supplementary Application 2025-02-07 Shandong New Time Pharmaceutical Co Ltd view
CXHL2500054 XZ157 XZ-157 Chemical Drugs(2.2) New Drug Application 2025-01-11 Shandong New Time Pharmaceutical Co Ltd view