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Business · 02/02/2001Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of 125 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) has withdrawn the approval of 125 abbreviated new drug applications (ANDA's) due to repeated non-compliance with annual reporting requirements by the application holders.

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

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