Entreprise · 02/02/20011 min de lecture
John J. Ferrante et al; Withdrawal of Approval of 125 Abbreviated New Drug Applications
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is withdrawing approval of 125 abbreviated new drug applications (ANDA's). The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for these applications.