Business · 13/07/2020Updated: 10/17/2026 · 1 min read

InvaGen Pharmaceuticals, Inc. Withdraws Trandolapril Tablets ANDA Approval

Summary

The FDA is withdrawing approval of InvaGen's abbreviated new drug application for trandolapril tablets due to repeated failure to submit required data supporting bioequivalence, and the company waived its right to a hearing.

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

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