AbbVie Inc., et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen

Короткий зміст

The Food and Drug Administration (FDA) is withdrawing approval of 7 abbreviated new drug applications (ANDAs) for prescription drug products containing more than 325 milligrams (mg) of acetaminophen. The holders of these ANDAs have waived their opportunity for a hearing.