Glaxo, Inc., et al.; Withdrawal of Approval of 13 Abbreviated Antibiotic Applications and 2 Abbreviated New Drug Applications

摘要

The Food and Drug Administration (FDA) is withdrawing approval of 13 abbreviated antibiotic applications (AADA's) and 2 abbreviated new drug applications (ANDA's). The holders of the applications notified the agency in writing that the drug products were no being longer marketed and requested that the approval of the applications be withdrawn.