Business · 26/03/2026Updated: 10/16/2026 · 1 min read

Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction

Summary

The FDA is correcting a notice regarding the withdrawal of approval of 72 abbreviated new drug applications (ANDAs), including one for valproic acid, after receiving a timely request from Upsher-Smith Laboratories, LLC to keep the approval in effect.

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

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