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Business · 13/08/2018Updated: 10/17/2026 · 1 min read

Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications

Summary

The US Food and Drug Administration (FDA) is withdrawing approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants, following written notifications from the applicants that the drug products are no longer commercially available.

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

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