Notice
4 Aug 2025
pharmaceuticals, fda, drug approval, generic drugs, acetaminophen, oxycodone
💊FDA Affirms ROXICET Availability for Generic Drug Applications
The Food and Drug Administration (FDA or Agency) has determined that ROXICET (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxycodone HCl and acetaminophen tablet, 5 mg/ 325 mg, if all other legal and regulatory requirements are met.
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