FDA Corrects Notice on Withdrawal of 23 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that incorrectly announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, effective March 7, 2019, and specifically removed the incorrect ANDA 077895 for Ursodiol Capsules USP, 300 milligrams, held by Impax Laboratories, LLC.