Parke-Davis et al.; Withdrawal of Approval of 18 New Drug Applications, 7 Abbreviated Antibiotic Applications, and 53 Abbreviated New Drug Applications

الملخص

The Food and Drug Administration (FDA) is withdrawing approval of 18 new drug applications (NDA's), 7 abbreviated antibiotic applications (AADA's), and 53 abbreviated new drug applications (ANDA's). The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.