FDA Approves Multiple Risperidone Tablet Products under ANDA 078269

The U.S. Food and Drug Administration (FDA) has approved a series of oral risperidone tablet products under the Abbreviated New Drug Application (ANDA) 078269. All products are prescription‑only, oral tablets, and are not designated as reference drugs. Approved strengths include 0.25 mg (product 001), 0.5 mg (product 002), 1 mg (product 003), 2 mg (product 004), 3 mg (product 005), and 4 mg (product 006). Each tablet contains the active ingredient risperidone at the listed strength and is marketed under the brand name RISPERIDONE. The FDA’s labeling review record shows multiple supplemental submissions (SUPPL) that received approval status (AP). Notable submission dates include February 10 2012 (submission 6), April 22 2011 (submission 4), October 22 2012 (submission 8), and more recent approvals on January 21 2020 (submissions 12 and 14) and May 3 2025 (submission 16). All submissions pertained to labeling updates for the approved tablet products.