Business · 02/12/1998Updated: 10/17/2026 · 1 min read

Vale Chemical Co., Inc., et al. Seek FDA Hearing on Withdrawal of 13 New Drug Applications and 1 Abbreviated New Drug Application

Summary

The FDA is offering a hearing for Vale Chemical Co., Inc., et al. to discuss their proposal to withdraw approval of 13 new drug applications (NDA) and 1 abbreviated new drug application (ANDA), due to repeated failure to submit required annual reports.

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

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