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Business · 02/09/2020Updated: 10/17/2026 · 1 min read

Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications; Correction

Summary

The FDA is correcting a notice that withdrew the approval of 16 new drug applications, including Monodox capsules, after receiving a withdrawal request from Aqua Pharmaceuticals, LLC, due to a timely request to preserve the approval.

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

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