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

摘要

The Food and Drug Administration (FDA) is withdrawing approval of 108 abbreviated new drug applications (ANDAs) for prescription pain medications containing more than 325 milligrams (mg) of acetaminophen. The holders of these ANDAs have voluntarily requested that approval of these applications be withdrawn and have waived their opportunity for a hearing.