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Business · 21/07/1997Updated: 10/17/2026 · 1 min read

Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications; Correction

Summary

The FDA is correcting a notice that withdrew approval of 39 new drug applications, 13 abbreviated antibiotic applications, and 46 abbreviated new drug applications, including an incorrect withdrawal of approval for DYNABAC (dirithromycin tablets) by Lilly Research Laboratories, which is still under approval.

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

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