FDA Corrects Notice on Withdrawal of 12 Abbreviated New Drug Applications, Including Error in Lederle Laboratories' Nystatin Ointment Approval

Summary

The Food and Drug Administration (FDA) is correcting a notice regarding the withdrawal of approval of 12 abbreviated new drug applications (ANDAs), including a mistake in the application number for Lederle Laboratories' Nystatin Ointment. The FDA previously withdrew the approval of these ANDAs as of June 11, 2021, but the error was discovered in a May 12, 2021, notice in the Federal Register.