FDA Approves ANDA085911 for Oxycodone 5/APAP 500 Oral Tablet

The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered ANDA085911 for an oral tablet containing 5 mg oxycodone hydrochloride and 500 mg acetaminophen, marketed under the brand name Oxycodone 5/APAP 500. The product, submitted by Bristol Myers Squibb, received an approval status (AP) on October 25, 1977. FDA records indicate the marketing status is listed as discontinued.