Regulatory Updates
Sep 27, 2026•1 min read
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.
Regulatory Updates
Sep 27, 2026•1 min read
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.
Regulatory Updates
Sep 19, 2026•1 min read
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.
Regulatory Updates
Sep 11, 2026•1 min read
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.