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Business · 25/09/1997Updated: 10/17/2026 · 1 min read

Helen A. Ballack Co. et al. Withdraw FDA Approval for 105 Drug Applications

Summary

The FDA is withdrawing approval for 61 new drug applications, 8 abbreviated antibiotic applications, and 36 abbreviated new drug applications, following written notifications from applicants that the drug products are no longer marketed.

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

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