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Business · 05/12/1997Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of 11 Antibiotic and 105 New Drug Applications by Zenith Goldline Pharmaceuticals

Summary

The FDA is withdrawing approval of 11 abbreviated antibiotic applications and 105 abbreviated new drug applications following a request from Zenith Goldline Pharmaceuticals, which notified the agency that the drug products are no longer commercially available.

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

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