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27 thg 9, 2026•1 phút đọc
FDA Approves ANI Pharmaceuticals' Risperidone Oral Solution (ANDA076440)
FDA approved ANDA076440 for ANI Pharmaceuticals' risperidone oral solution (1 mg/mL), a prescription atypical antipsychotic, with recent labeling updates in July 2024.
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27 thg 9, 2026•1 phút đọc
FDA Approves Multiple Risperidone Tablet Strengths Under ANDA 078871
FDA has approved six oral tablet strengths of risperidone (0.25 mg to 4 mg) as prescription products, with labeling updates from 2008 to 2023.
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19 thg 9, 2026•1 phút đọc
FDA Approves Multiple Risperidone Tablet Products under ANDA 078269
FDA has approved several oral risperidone tablet strengths ranging from 0.25 mg to 4 mg under ANDA 078269, with labeling submissions completed.
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11 thg 9, 2026•1 phút đọc
FDA Approves Risperidone Tablet ANDA077784 Submitted by Ratipharm
FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.