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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
JYSB2400212 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2024-09-25 Patheon Italia SpA;Recordati Netherlands BV view
JYSB2400167 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2024-07-30 Patheon Italia SpA;Recordati Netherlands BV view
JYSB2400003 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2024-01-03 Patheon Italia SpA;Recordati Netherlands BV view
JYSB2300116 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2023-07-04 Patheon Italia SpA view
JYSB2200222 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2022-12-20 Rentschler Biopharma Se view
JYSB2200096 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2022-06-14 Rentschler Biopharma Se view
JYSB2200041 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2022-03-15 Patheon Italia SpA;Recordati Netherlands BV view