FDA Approves ANDA090265 for Hydrocodone/Acetaminophen Tablets

The Food and Drug Administration (FDA) has recorded an Abbreviated New Drug Application (ANDA) identified as ANDA090265. The original submission (submission number 1) was made by CARACO and received an approval status (AP) on December 23, 2008. The application covers three oral tablet products marketed under the brand name HYDROCODONE BITARTRATE AND ACETAMINOPHEN. All three tablets contain 500 mg of acetaminophen combined with varying strengths of hydrocodone bitartrate: 5 mg (product number 001), 7.5 mg (product number 002), and 10 mg (product number 003). Each product is listed with a marketing status of "Discontinued" and is not designated as a reference drug or reference standard. No further information on current market availability or future plans for these products is provided in the FDA record.