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

摘要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 27, 2014 (79 FR 17163). The document withdrew approval of 108 abbreviated new drug applications (ANDAs) for prescription pain medications containing more than 325 milligrams (mg) of acetaminophen per dosage unit from multiple applicants, effective March 27, 2014. The document failed to withdraw approval of ANDAs 040825, 040822, and 040824, held by Ranbaxy Laboratories Inc. and Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540, and ANDA 040182, held by Pharmaceutical Associates, Inc., 201 Delaware St., Greenville, SC 29605. The holders of these applications have voluntarily requested that approval of these applications be withdrawn and have waived their opportunity for a hearing. FDA confirms the withdrawal of approval of ANDAs 040825, 040824, 040822, and 040182.