FDA Approves ANI Pharmaceuticals' Risperidone Oral Solution (ANDA076440)

The U.S. Food and Drug Administration has granted approval for application ANDA076440, covering an oral solution of risperidone manufactured by ANI Pharmaceuticals (ANI PHARMS). The product is classified as a human prescription drug and is indicated for use as an atypical antipsychotic. The approved dosage form is a solution for oral administration, containing risperidone at a strength of 1 mg/mL. It is marketed under the brand name RISPERIDONE with the National Drug Code 62559-981-30 (product NDC 62559-981). The product is listed with identifiers including NUI N0000175430, UNII L6UH7ZF8HC, and RxCUI 199387. Submission history shows the original approval (submission 1) on January 30, 2009. Subsequent labeling supplements were approved on December 15, 2009; January 11, 2011; May 27, 2011; October 27, 2011; and July 14, 2024 (submissions 6, 7, and 8). All submissions were classified under the labeling category. The product is marketed as a prescription medication and falls under the pharmacologic class of atypical antipsychotics.