Business · 13/02/2018Updated: 10/17/2026 · 1 min read

Mallinkrodt Pharmaceuticals LLC Withdraws Approval of PEMOLINE Tablets ANDA

Summary

Mallinkrodt Pharmaceuticals, LLC has withdrawn its abbreviated new drug application for PEMOLINE Tablets in various strengths, following its own request and waiver of a hearing with the FDA.

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

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