FDA Approves ANDA087463 for Oxycet (Oxycodone/Acetaminophen) Tablet

The U.S. Food and Drug Administration (FDA) has granted approval for application ANDA087463. The approved product is marketed under the brand name Oxycet, a prescription oral tablet that combines oxycodone hydrochloride (5 mg) with acetaminophen (325 mg). The product is classified as a human prescription drug and is manufactured by SpecGx LLC. It is listed under the generic name Oxycodone Hydrochloride and Acetaminophen and is available in multiple NDC package codes (e.g., 0406-0512-01, 0406-0522-05, etc.). Submission history shows a series of manufacturing (CMC) and labeling supplements dating back to 1988, with the most recent labeling supplement (submission number 56) approved on March 4, 2024. All submissions to date have received an "AP" (Approved) status. The tablet is intended for oral administration and is designated as a prescription‑only medication.