FDA Corrects Withdrawal of Approval for 12 New Drug Applications, 8 Abbreviated Antibiotic Applications, and 23 Abbreviated New Drug Applications

Summary

The FDA is correcting a notice that withdrew approval of 12 new drug applications, 8 abbreviated antibiotic applications, and 23 abbreviated new drug applications, including a portion of an application for the 200mg tablet of the medication Tambocor (flecainide acetate), which was incorrectly withdrawn by the FDA in a notice published on October 2, 1996.