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Business · 02/02/2023Updated: 10/17/2026 · 1 min read

FDA Corrects Withdrawal of Approval for 10 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on November 21, 2022, regarding the withdrawal of approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants, including Sunstar Americas, Inc., Sofgen Pharmaceuticals, LLC, and Indicus Pharma, LLC, after receiving withdrawal requests from these companies.

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

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