Regulatory UpdatesSep 19, 2026•1 min read

FDA Approves ANDA085911 for Oxycodone 5/APAP 500 Oral Tablet

By the PharmaCountry team

FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as discontinued.

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.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Oxycodone #acetaminophen #ANDA #FDA #generic drug #Oral Tablet