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Entreprise · 10/07/20191 min de lecture
Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
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Résumé
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, has requested withdrawal of these applications and has waived its opportunity for a hearing.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →