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Business · 28/06/2023Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of Oxandrolone Tablets from Multiple Manufacturers

Summary

The FDA is withdrawing approval of new drug applications for oxandrolone tablets from Gemini Laboratories, LLC, and four other manufacturers, following voluntary requests from the companies to waive their hearing opportunities.

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

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