Business · 24/03/1999Updated: 10/17/2026 · 1 min read

Vale Chemical Co., Inc., et al.; FDA Withdraws Approval of 13 New Drug Applications and 1 Abbreviated New Drug Application

Summary

The US Food and Drug Administration (FDA) has withdrawn approval of 13 new drug applications (NDAs) and 1 abbreviated new drug application (ANDA) due to repeated failure to submit required annual reports by the applicants.

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

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