Business · 01/10/2021Updated: 10/17/2026 · 1 min read

FDA Corrects Withdrawal of Approval for 36 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) has corrected a notice regarding the withdrawal of approval for 36 abbreviated new drug applications (ANDAs), including one that was set to expire on July 26, 2021, after a timely request from Yung Shin Pharmaceutical Ind. Co. Ltd. to preserve the approval of the ANDA 065152 for Cephalexin Capsules.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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