FDA Corrects Withdrawal of Approval of 11 Abbreviated New Drug Applications from Dr. Reddy's Laboratories, Inc.

Summary

The FDA is correcting a notice that announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from Dr. Reddy's Laboratories, Inc. The correction reverses the withdrawal of approval for ANDA 203807, clozapine tablets, due to Dr. Reddy's Laboratories, Inc.'s timely request, which was made before the initial withdrawal notice was published.