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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL2400156 Dexpramipexole片 dexpramipexole Tablet Chemical Drugs(1) Import Drug Application 2024-07-04 Parexel China Co Ltd;Areteia Therapeutics Inc view
JXHB2500049 Dexpramipexole片 dexpramipexole Tablet Chemical Drugs(1) Supplementary Application 2025-04-16 Catalent Pharma Solutions LLC;Areteia Therapeutics Inc view
JXHB2500048 Dexpramipexole片 dexpramipexole Tablet Chemical Drugs(1) Supplementary Application 2025-04-16 Catalent Pharma Solutions LLC;Areteia Therapeutics Inc view
JXHL2400155 Dexpramipexole片 dexpramipexole Tablet Chemical Drugs(1) Import Drug Application 2024-07-04 Parexel China Co Ltd;Areteia Therapeutics Inc view