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Business · 04/09/2025Updated: 10/17/2026 · 1 min read

FDA Corrects Notice on Withdrawal of Approval of Eight Abbreviated New Drug Applications

Summary

The FDA is correcting a notice that announced the withdrawal of approval of eight abbreviated new drug applications, including one for amantadine hydrochloride syrup, after a company objected to the withdrawal.

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

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