FDA Approves Risperidone Tablet ANDA077784 Submitted by Ratipharm

The U.S. Food and Drug Administration has recorded an approval (status AP) for Abbreviated New Drug Application ANDA077784 on June 8, 2010. The original submission (submission number 1) was made by Ratipharm. The application covers six oral tablet products containing risperidone at the following strengths: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Each product is listed as a non‑reference drug, not a reference standard, and the marketing status for all six products is "Discontinued". No additional reference drug information is provided. The approval reflects the FDA’s regulatory processing of these generic risperidone tablets under the specified application number.