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Business · 17/06/2020Updated: 10/17/2026 · 1 min read

FDA Corrects Notice on Withdrawal of 16 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) has corrected a notice regarding the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, including Lupin Pharmaceuticals, Inc. The correction states that the approval of four ANDAs remains in effect due to Lupin Pharmaceuticals' timely request to prevent their withdrawal.

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

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